Example of documentation template for Human Resource

The following document templates (tool kits) are provided totally complimentary, free of charge to use as a starting point for Human Resource. As each business is different, additional documents or revisions would be required to meet your organization’s specific needs, requirements, context, risk profile, etc. If after reading through all of these documents, you feel like you still need a consulting partner to help you develop your new documents – Contact Us. We’re always looking for interesting new clients and projects.

1.0 Annual Training plan

YEAR – xxxx

Date:

Jan

Feb

Mar

Apr

May

June

July

Aug

Sep

Oct

Nov

Dec

Employee Details

Week

S.No

Employee Name

Designation

API – Q1 9th Edition – Awareness

Risk Assess, Cont.planning &MOC

Control of NC, CA & PA

HSE Insduction Tranning

Waste Management

Hydril Procedures

Contract Review & Customer Satisfaction

Store rec – issue, Receive, NC

Design and Development requirements

Heavy Lifting

QMS Procedures, Work instructions

API – 6A prodcuts requirements

Welding process requirements SAW,

Hazard Communication

Defensive Driving

VGS inspection templates

QC – Requirements & Calibration

MPI,LPT,UT Procedures

Power Tools

Hydro carbon Waste disposal

Machine Maintenance, NC Detection

Record Keeping &Document Mgt.

Purchasing Requirements

Fire Hazard

Use of PPEs

Monogram Product Requirements

Pressure Testing Requirements

Blasting & Painting

Electric Shock

Emergency Evacuation

Prepared by
Signature:

Date:

Reviewed by
Signature:

Date

Approved by
Signature:

Date

Iss.No./Date: 02/01.06.2013
Rev.No/Rev.Date:00/–

2.0 Training Request Form

Employee Name		Employee Number

Proposed Training Activity (Internal/ External)

Date(s)	Location			Total # Hours of Training (excluding travel time)

Registration Fee (show discounts if any)			Other Costs (travel, books, lodging, etc.)

Total Cost			Ref. of Training need analysis (if any)

Is release time needed? Replacement staffing?

Training Description (Why is it Necessary)

Employee & HR Sign: Name: Date:	MR Sign: Name: Date:	Chairman Sign: Name: Date:
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date: xx/xx.xx.xxxx

3.0 Attendance Sheet

Topic:		Date:	Time:
S.no	Name		Signature





















Iss.No./Date: xx/xx.xx.xxxx Rev.No/(Rev.Date): xx/xx.xx.xxxx

4.0 Training Feedback Form

Name Of the Programme :
Faculty :		Date :
Trainee Name :		Desig:
Sl. No.		Yes	No
1	Were you able to follow the program ? (If No, please explain)
2	Did you understand the objective? (If No, please explain)
3	Will it be useful for you to work better? (If No, please explain)
4	Did it increase your level of knowledge? (If No, please explain)
5	Rating of Programme: ( A-Excellent, B-Good C-Poor)
a)	Course Contents
b)	Faculty
c)	Course Materials
	Signature of the Trainee
Other remarks
Iss.No./Date: xx/xx.xx.xxxx Rev.No/(Rev.Date): xx/xx.xx.xxxx

5.0 Certificate Request Form

Name	…………………………………………………	Hiring Date	….…./……..…./…………	Emp. No	…………………

Designation	…………………………………………………	Department	………………………………	Cost Center / JO	…………………

Salary Certificate

Continuity Certificate

Credit Card

Arabic

English

Civil ID or Passport No.

Addressed to

Reasons

Employee	Head Of Department	Personnel Officer

Note: Attach copy with the certificate signed by the employee

6.0 Interview Analysis – Local

Name of Candidate
Interviewed for the post of:
Department		Reporting to
Date of Interview		Availability
Visa Status		Agency(if any)
Validity of Visa		Contact No.
*Skills* *& Competency*	*Description*		*Excellent*	*Good*	*Average*	*Poor*
			10	8	5	2
Education
Training & Certification
Relevant Experience
Proven Skills
Work Knowledge
Trade Test (If any)
Total Grading:
Interview Assessment
Summary:
Training Need (If any):
Salary:	Last Received	Expectation			Offered

Other Allowances:	Company Vehicle/Transport	Mobile			Accommodation

Employment Status	Current	Notice Period			Exp. Joining Date

Conclusion	Acceptance of Candidate	Action to be taken by the company

For HR use:
Document required & to be verified. (CV/PP copy, interview details/ others if any)	Trade Test (if any) Certificate attested by Kuwait Council
	Bio-data Signato Work permit Civil ID Passport Copy
Signature with Date
Interviewed By:	Reviewed By: HR		Approved By: GM/AGM

Iss.No./Date: xx/xx.xx.xxxx Rev.No/(Rev.Date): xx/xx.xx.xxxx

7.0 Interview Analysis – Abroad

Name of Candidate
Post Applied for		Availability
Place of Interview		Agency(if any)
Date of Interview		Agency Contact No.
Passport No.		Candidate Cont. No.
Passport Validity		Date of Birth
*Skills* *& Competency*	*Description*		*Excellent*	*Good*	*Average*	*Poor*
			10	8	5	2
Education
Training & Certification
Relevant Experience
Proven Skills
Work Knowledge
Trade Test (If any)
Total Grading:
Interview Assessment
Summary:
Training Need (If any):
Salary:	Last Received	Expectation			Offered

Other Allowances:	Joining Ticket	Food/Accomodation/Mobile			Transportation

Employment Status	Current	Notice Period			Exp. Joining Date

Conclusion	Acceptance of Candidate	Action to be taken by the company

For HR use:
Document required & to be verified. (CV/PP copy, interview details/ others if any)	Bio data	Certificate attested by Ministry
	Passport Copy	Trade test
Interviewed By:	Reviewed By: HR		Approved By: GM/AGM

Iss.No./Date: xx/xx.xx.xxxx Rev.No/(Rev.Date): xx/xx.xx.xxxx

8.0 Personnel Interview Record Form

Name
Post Applied For
Passport No.
Passport Validity
Civil ID No.
Visa Status
Visa Validity
Type of Visa
Transferable/Non-Transferable
Visa Required/Not Required
Contact Number	Local	International
Qualification
Additional Qualification
Experience in Years
Iss.No./Date: xx/xx.xx.xxxx Rev.No/(Rev.Date): xx/xx.xx.xxxx

9.0 Job Application form

Please fil the complete form:

Recent Photo

Position Applied for:

Personal Information:

Full Name:

First:

Second:

Third:

Last:

Blood Type:

Marital Status:

Gender:

Place of Birth:

Date of Birth:

Nationality:

Date of Expiry:

Passport Type:

Passport No.:

Date of Expiry:

Article No.:

Civil ID No.:

Permanent Address:

Current Address:

Mob. No.:

E-mail Address:

Do you have any medical issue that requires attention? Please mention with the medication you use

In case of Emergency, please mention first of kin

Please mention your dependents’ details below:

Sr no

Name

Date of Birth

Relations

Educational Qualifications:

Please mention your Educational Qualification starting from the highest

Sr no

Country

University / Collage

Year

Degree

Please mention your Professional Certificates

Sr no

Country

College / Institute

Year

Certificate

Language Skills

Language

English

Arabic

Reading

Written

Speaking

B = Basic (Basic with no practice) – G = Good (Handle Conversations) VG = Very Good (Conduct high end discussions) – EX = Excellent

PC Skills

Level

Fair

Good

Very Good

Excellent

Basic PC

MS Word

MS Excel

MS PowerPoint

MS Outlook

Internet

AutoCAD

MS Project

Primavera

Professional Experiences

Please mention last three companies your worked for starting from current or last company then the one before

Company Name

Last Salary

Job Title

Tasks

Company Name

Last Salary

Job Title

Tasks

Company Name

Last Salary

Job Title

Tasks

Other Information:

Do you have a valid driving license?

Yes /No

Type

Are you currently working?

Yes /No

When can you join work?

Can we contact your current employer?

What is your expected salary?

References: Please provide two of your references at work

Sr no

Name

Job Title

Company

Contact Number

Statement: By signing this application, I hereby state that all information provided are true, and any false information will hold me subjected to all legal and contractual responsibilities including dismissal.

Date:

Signature:

Attachment:

Please Attach the following: Recent Photograph Resume’ Work Permit Copy Civil ID Copy Passport Copy Residency Page Copy Educational Certificates copies Experience Certificates Copies

10. Joining Date Notification – New Recruit

New Recruit To: Administration Name: File No.: Date of Joining: Position: Salary: Department / Project: Division: Induction By: Advance: Employee’s Signature Personal Dept. Signature Finance Manager Signature
Medical Done: Residence Stamped: Civil ID Applied: PRO Signature: Personal Dept:
Date resumed Duties(in Case of Leave) Leave Granted From To On time / Earlier / Delayed No. of days late: Reason for delays: Dept. Manager Signature: Date:_
Administration Department: Signature:
Distribution Personal File & Finance
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

11. Joining Date Notification – New Recruit

To: Administration Date: / / Name: File No.: Date of Joining: Position: Salary: Department / Project: Division: Induction By: Advance: Employee’s Signature Personal Dept. Signature Finance Manager Signature
Date resumed Duties(in Case of Leave) Leave Granted From To On time /Earlier / Delayed No. of days late: Reason for delays: Dept. Manager Signature: Date:
Administration Department: Signature:
Distribution Personal File & Finance
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

12. Job Offer Letter

Date:

Dear:

Based on our interview and discussions we are pleased to inform you that you have been selected for the employment in accordance with the following terms and conditions:

Position

Reporting to

Key job roles

Temporary assignment

Probationary Period

Training (if any)

Basic Salary

Housing Allowance

Transportation

Mobile

Additional

Leave

Annual Air Ticket

Medical Insurance

Other

Eligibility for annual leave will be applicable only after successful completion of one full year

Documents to be submitted upon joining

Passport Original

Copy of Civil ID

Qualification Certificate attested

Employment Contract current

Signatory Proof

Other as needed by HR

Issued by

Signature & Date

Designation:☑

Chairman

GM/AGM

HR Manager

Position

Offer Acceptance

Name:

Signature & Date

Note: Issuance of this document will be valid only with the signature of one of the below:

Chairman
General Manager/ AGM
HR Manager

13. Employee Performance Evaluation

Emp. Name:			Employee No.:
Designation:			Evaluation Dt.:
PART – A		*(To be completed with the employee and supervisor)*
A.1	Quality of Work Competence, accuracy, neatness, thoroughness.			☐ Outstanding
				☐ Exceeds Expectations
				☐ Meets Expectations
				☐ Needs Improvement
				☐ Unsatisfactory
A.2	Quantity of Work Quantity with quality, planning skills, ability to meet schedules, less rework			☐ Outstanding
				☐ Exceeds Expectations
				☐ Meets Expectations
				☐ Needs Improvement
				☐ Unsatisfactory
A.3	Job Knowledge Degree of technical knowledge, understanding of job procedures and methods.			☐ Outstanding
				☐ Exceeds Expectations
				☐ Meets Expectations
				☐ Needs Improvement
				☐ Unsatisfactory
A.4	Working Relationships Co-operation and ability to work with supervisor, co-workers, and clients			☐ Outstanding
				☐ Exceeds Expectations
				☐ Meets Expectations
				☐ Needs Improvement
				☐ Unsatisfactory
A.5	Supervisory Skills Training skills, work allocation skills, monitoring skills, problem solving, decision making, communication			☐ Outstanding
				☐ Exceeds Expectations
				☐ Meets Expectations
				☐ Needs Improvement
				☐ Unsatisfactory
A.6	Other Factor Language, adaptability, judgment, initiative, problem solving, improvement in job etc.			☐ Outstanding
				☐ Exceeds Expectations
				☐ Meets Expectations
				☐ Needs Improvement
				☐ Unsatisfactory
A.7	Cost Saving Alternate methods, time saving, new developments, competitiveness, Achievements Time, money, outcome			☐ Outstanding
				☐ Exceeds Expectations
				☐ Meets Expectations
				☐ Needs Improvement
				☐ Unsatisfactory
PART B		*(To be communicated to the employee by the supervisor)*
B.1	Performance Goals for the Next Evaluation Period
B.2	Training and Development Suggestions
B.3	Next step in Career Ladder
Evaluated by				Dt.:
Acknowledged by Employee				Dt.:
*Note: After completing PART A & B return to HR to complete PART C*
PART C		*(To be completed by HR Department)*
Dt of Joining:			Joining Salary:
Starting job:			Current position:
No of increments:			Last increment:
Quality Violation:			Behavioural Violation:
PART D		(By Operations Manager/AGM/GM)
D.1	Overall Assessment (this may be completed by the authorised after discussing with the line manager)
D.2	Recommendation (this may be completed by the authorised after discussing with the line manager))
Signed by: OM/AGM/GM				Dt.
Approved by: GM/Chairman				Dt.
PART E		*(To be completed by HR Department)*
ACTION TAKEN
#	Date	Description
1
2
3
4
5
SIGNED AS COMPLETED
HR Manager				Dt.

14. Personal Permission

Date of Mission Work
Name of Employee
Employee No.
Time	From	To

Place of the task	1
	2
	3
Employee’s Signature Manager’s Signature
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

15. Travel / Leave Application

(To be forwarded by sanctioning authority to Finance Manager)

Name in (block letters) as in passport:

Employee #: Department: Designation:

Purpose of travel:
Annular Leave: Y/N
Business: Y/N
Both: Y/N
Emergency: Y/N

No. of days leave: No. of days business:

Proposed date for travel: Proposed date of return:

Details of journey arrangements to be made:

Hotel Accomodation Required: Y/N
Allowance Required: Amount:
Travel to be borne by: Company: Individual: Both:
Contact address while on leave:

Tel / fax #:

Signature of the employee: Date:

Recommended and forwarded- A substitute is/not necessary:

Not approved: Section in-charge:

Leave sanctioned for days from to
Department manager’s signature

General manager’s Sginature

FOR OFFICIAL USE ONLY
No. of days leave eligible:
No. of days entitled for:
Passport No.                                             Expiry Date:                                                Visa Expiry Date:

Ticket bookings:
Dep. Dt:
Route:
Flight #:
Time:
Arrival Dt.:
Route:
Flight #:
Time:

Pay prior to leave: Y/N        Amount hold:_                                            Pay upon arrival:
Deduction(if any):                                   Fare:

Accountant:                                              Finance Manager:

White copy – Personal File, Blue Copy – Originator, Yellow Copy – Master File.

Iss.No./Date: xx/xx.xx.xxxx
Rev.No/Rev.Date:xx/xx.xx.xxxx

16. Employee Annual leave declaration letter

Sub: EMPLOYEE’S DECLARATION LETTER

I am (name) employed at XXX. In the designation of and having employee no. declare that I will be going for my Annual leave and it is fully committed to be return on the declared date which is on No of days – (Annual leave entitled 30 days). Otherwise the Company has the right to Terminate my services, and I have no right to declare any of my Financial Dues or any Indemnities.

Yours Sincerely,

Emp. No

Name & Signature

H.R.Dept. and Personnel / Admin.

17. Employee Discharge Declaration

I, hereby acknowledge, declare, admit, and confirm that I have reached an amicable full settlement with XXX Co. (hereinafter XXX) in respect of my employment with (XXX) and have received all my rights, accruals from XXX including any salaries, commission, leaves, indemnities over time and all other benefits as from the date of my employment with XXX commencing on until the date hereof and hereby accept the lump sum of cash as full and final and complete settlement of all XXX s obligation towards me.

I hereby declare that I have no past, present or future claims against XXX for the period of service which is now concluded and admit that I finally irrevocably and unconditionally discharge, acquit and release XXX from any liability, obligation or responsibility whatsoever and what ever kind, nature, origin, or amount relating to or arising from my employment with XXX and its termination. Further, I hereby irrevocably and unconditionally undertake not to any claims, demands, litigation or any other contention for any other, dues or sums of money whatsoever in respect of the employment. All being waived under the terms herein.

Signed:

Date:

18. Clearance Form

Date: / /
Name:
Nationality:
Position:
Clearance Reason	Other	Final Exit	Emergency	As per contract

EMP. Affairs
Car: Sing.		Has no car		Handed the car
House: Sing.		Has no house		Handed the house
Office: Sing.		Has no office		Handed the office
computer: Sing.		Has no computer		Handed the computer
Tel: Sing.		Has no phone		Handed the phone
Other Advance
HR Manager
Advance & Petty Cash
Financial lib.
Financial administration confirm:
Direct Manager:
Pay & Received passport
Do not pay & Received passport
Because:
Phones during his vacation 1 – 2 –
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx-

19. Temporary Delivery of a car.

Name	Emp.No.	Date of received		Meter read when received	Date of return the car		Meter read. when return	The recipient
Name	Emp.No.	Day	Hour	Meter read when received	Day	Hour	Meter read. when return	The recipient















Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx-

20. Vehicle Issue form

Series: ……………….. Operating order No. …………….. Date: / / Company name: ………………………………………………………….. Local number: ……………………. Plate No. …………………………. Type the stomach: ………………. Meter reading: …………………… The driver Name, number: ………………………………………………. Project: ……………………………. Date of repairing: / /
Statement Garage
…………………………………………………………………………………………………………………….
……………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………
…………………………………………………………………
I received MR: ………………………………………………..
Number: ……………………………………………………….
Car after completing validity and valid for work.
Recipient: ……………………………………………………..
Director garage: ………………………………………………
Statement	Details	Unit price	Amount
Spare Parts
Type maintenance
External Work
Wage Workers
Total
Name: ……………………………………………………………… Signature: ………………………………………………………….
Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

21. Mobile Sim Card issue Form

The company will pay a maximum of                  per month for all business calls. Any private use made of the phone must / will be paid by the holder. The SIM CARD pin code shoudn’t be changed from the one issued with the SIM CARD upon receiving it. If the SIM CARD is lost or stolen the holder must inform the company immediately. It is the responsibility of the holder to hand over the SIM CARD to personal & Admin Department 24 hrs before departing on leave. The SIM CARD, should not be left at personal residence or handed over to any person without prior permission of the General Manager or the personal and Admin Department.
Name of the Holder: ………………………………………………….     ( EMP.code                 )

Signature: ……………………………………………………………..
Date: …………………………………………………………………..
Telephone : ……………………………………………………………
I Have the following in my possession
1)                 Sim Card
2)
3)

HR Dept.                                                                      GM

Issue.No./Date: xx/xx.xx.xxxx
Rev.No/Rev.Date:xx/xx.xx.xxxx

22 Overtime Request Sheet

Overtime for the Department:								Date:
								Month:
Job No:		Description:						Period
S. NO	Category		Estimated	Normal	Normal	Sumcay	Holiday	Justification for over time
			TOTAL	HRS	OT	OT	OT
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Note: Approval for OT shall be taken prior to keep any person for OT If limit exceed than approved shall be requested and approval shall be taken from GM prior to continue OT working OT Time sheet shall be submitted with OT approval/approved Over Time Request Sheet
Prepared by				Reviewed by:			Approved by
Name:				Name:			Name:
Signature:				Signature:			Signature:
Date:				Date:			Date:
Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

23. International Fax/Call Request Form

CALL/FAX Requested By:
Department:
Destination:
Tel/Fax Number:
Name of Company:
Contact Person:
Reason for CALL/FAX:
Job Number:
Date:
(REQUESTER’S SIGNATURE) (APPROVAL SIGNATURE)
Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

24. Hand Over Record

Date : __ /__ / 20__

PERSONNEL ON LEAVE : ________________________________

EMP NUMBER : ________________________________

DESIGNATION : ________________________________

RESPONSIBILITIES HANDED OVER TO : ________________________________

DESIGNATION : ________________________________

HANDOVER DURATION : ________________________________

RESPONSIBILITIES INCLUDE : ________________________________

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

SPECIAL TASK: _________________________________________________________________

______________________________________________________________________________

Hand Over By: Sign and Date

___________________________

Hand Over To: Sign and Date

___________________________

Original: HR Copy: Copy:

25. Time-Off Permission

Name	…………………………………………………	Hiring Date	….…./……..…./…………	Emp. No	…………………

Designation	…………………………………………………	Department	………………………………	Cost Center / JO	…………………

Reason for permission		Duty		Personal	Others
Reason for permission		Late arrival		Early Leave	Others

Kindly allow me time-off on

Date

….…./……..…./…………

Start Time

….……:………

End Time

….……:………

Reasons

…………………………………………………………………………………………………………………………………………………. …………………………………………………………………………………………………………………………………………………. …………………………………………………………………………………………………………………………………………………. …………………………………………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………………………………………….

Employee	Head Of Department

For HR Dept. Use Only Deduct/ Not Deduct
Remarks

Personnel In-Charge			HR Manager

26. Company Sponsorship transfer request

Name	…………………………………………………	Hiring Date	….…./……..…./…………	Emp. No	…………………

Designation	…………………………………………………	Department	………………………………	Cost Center / JO	…………………

Please transfer my residency on company sponsorship
Employee	Head of Department

Probation period completion status	Yes/No Exception
	Reason	……………………………………………………………………
Title in work permit Salary in Work Permit Duration Date of Residence Expiry ….…./……..…./…………

HR Manager	Chief Executive Officer & GM

27. Medical Leave Request form

Name	…………………………………………………	Hiring Date	….…./……..…./…………	Emp. No	…………………

Designation	…………………………………………………	Department	………………………………	Cost Center / JO	…………………

Employee	Line Manager	Personnel in Charge	Company Stamp

Kindly examine & diagnose the above mentioned Employee, Your medical treatment and recommendation along with your diagnosis is highly appreciated
Doctor’s Diagnosis and Recommendations

Days of Rest Recommended

Doctor & Hospital / Clinic Stamp	………………………………	Doctor’s Signature
	….…./……..…./…………	Date

Notes: Inform HR Dept. within 24 hours if you have sick leaveIn case of emergency that may cause delay your return, inform HR Dept.The Hospital / Clinic Stamp is necessary to accept medical leave.

28. Employee Transfer Request

Employee Transfer Request

Name	…………………………………………………	Hiring Date	….…./……..…./…………	Emp. No	…………………

Designation	…………………………………………………	Department	………………………………	Cost Center / JO	…………………

*Please transfer the employee start from*		….…./……..…./…………
Transfer Data	From		To	Remarks
Company /Dept.	………………………………..		………………………………..	………………………………………………..
Designation	………………………………..		………………………………..	………………………………………………..
Salary	………………………………..		………………………………..	………………………………………………..

Signature of Old Manager	Signature Of New Manager

Employee Comment
Signature

Remarks
HR Manager			Financial Manager		Chief Executive Officer & GM
☐	Within Budget	☐



Signature			Signature	Signature

29. Change of status Form

Name	…………………………………………………	Hiring Date	….…./……..…./…………	Emp. No	…………………
Designation	…………………………………………………	Department	………………………………	Cost Center / JO	…………………

Effective Date: Recommended by Head of Department: ……. / ….. / ………….

Administrative Variables

Particulars

Existing

Change To

Department

Cost Centre

Job Title

Job Grade

Financial Variables

Salary (KD)

Existing

Change To

Net Change

% Change

Basic Salary

Housing Allowance

Company Housing

Conveyance Allowance

Other Allowances:

Total (KD)

Benefits Variables

Benefits

Existing

Change To

Cost Change (KD)

% Change

Company Car

Annual Leave (Days)

Mobile Limit

Leave Passage

Self / Family

Sector / Class

Time Frame

Due to the following

Previous 3 Increments

………………………………………………………………………………… ………………………………………………………………………………… ………………………………………………………………………………… …………………………………………………………………………………

Date

Amount (KD)

Head Of Department

………………………………………

Personnel Officer

………………………………………

Final Approval By HRC.
HR Manager	GM & CEO

Updated in Systems.	Verified in Systems.
HR Department	Finance Department

30 Manpower Requisition Form

Department	………………………………………………………………………
Section	………………………………………………………………………
Project	………………………………………………………………………
Job / Position Title	………………………………………………………………………
Position Classification	Existing Position	☐	☐
Reasons of Hiring	☐ Replacement ☐Approved by Annual Budget ☐ New Position ☐ Business need (Out of budget)
Request within Budget				Out of Budget
Job Description (To be filed if JD is not available)	……………………………………………………………………… ……………………………………………………………………… ……………………………………………………………………… ………………………………………………………………………
Years Of Experience	………………………………………………………………………
Expected Hiring Date	.… /.…/………
Hiring Resources	Candidate is Available			From HRM
Recommendation
Line Manager				Head of Department

31. Probation evaluation Form

Name	…………………………………………………	Hiring Date	….…./……..…./…………	Emp. No	…………………

Designation	…………………………………………………	Department	………………………………	Cost Center / JO	…………………

No	Performance Factors Measured	Exceeds Expectation	Meets Requirement	Underperformance
1	Efficiency in his/ her work
2	Execution Skills/ Role Effectiveness
3	Ability to learn new things and adapt at work
4	Reliability and responsibility
5	Communication with colleagues,supervisors and subordinates
6	Positive Attitude
7	Interpersonal & Team Working Abilities
8	Appearance and Manners

Based on the evaluation we recommend the following:
	Qualified and to assign permanently			Employee doesn’t meet work requirements, end services

Remarks :


Employee		Direct In-charge			Head of Department


HR Manager			GM & Chief Executive Officer (End of Services only)

32. Induction Training Form

EMPLOYEE DETAILS
Name:			Employee No:
Designation:			Department:
Date of Joining:			Type of Employment:		Permanent/Temporary
Reporting to:			Training Assigned by:
TRAINING GIVEN
#	Subject	Contents of the training		Training given by		Employee Signature
1	Quality Management System (QMS)	Quality Policy Quality Objectives Governing Standards & Specifications Non-conformance & reporting Suggestions for improvement
2	Health, Safety & Environment Management (HSE)	HSE Policies & Objectives Restricted Entries & Personnel Safety Emergency Preparedness Site Tour (Key points – exit, assembly) Visitors policy Housekeeping & Safe working practice
3	Code of Conducts (COC)	Company Rules & Regulations Kuwait Labour Law Business Ethics Business Conduct Grievance Violations & Actions
4	Job Roles & Responsibilities (JRR)	Responsibility, Authority & Accountability Organization & Communication Internal & External Communication Confidentiality Agreement Key Performance Indicators Training Needs
CONFIRMATION AFTER PROBATIONARY PERIOD
#	Subject	Assessment		Yes/No		Signed by
1	QMS	Employee Understood the QMS requirements and evidence of adhering to it.
2	HSE	Employee Understood the HSE requirements and evidence of adhering to it.
3	COC	Employee Understood the COC requirements and evidence of adhering to it.
4	JRR	Employee Understood the JRR requirements and evidence of adhering to it.

33. Training Effectiveness Form

EMPLOYEE NAME:

ID NO:

DEPARTMENT:

TRAINING:

TRAINING FACULTY:

TRAINING START DATE: TRAINING END DATE:

(1) Has the training helped the employee to apply to his area of work, the knowledge gained on the training course?

(2) Has the training assisted the employee to close the skill gap that was registered prior to the training?

(3) Overall, has this training helped to make the employee more productive in his area of work?

Please rate the below to understand how the training has helped the employee in his work area in comparison to that prior to training:
(a) Excellent (b) Good (c) Needs improvement (d) Not Applicable

S No.	Measurement Parameter	Pre – Training Effective Quite Effective Ineffective	Post – Training Effective Quite Effective Ineffective
1	ERROR RATING
2	PROCESSING TIME
3	RESPONSIBILITIES HANDLED
4	MEETING DEADLINES
5	CONFIDENCE TO CARRY OUT WORK TASK
6	LEVEL OF SUPERVISION REQUIRED
7	QUALITY OF WORK
8	OVERALL PRODUCTIVITY
9	OBJECTIVES MET
10	COST SAVING (IF, IDENTIFIED)
	Overall

EVALUATOR NAME :	HR REPRESENTATIVE’S NAME:
SIGNATURE :	SIGNATURE :
DATE:	DATE:

34. Training Matrix

35 Training need analysis

Designation: Machinist

Employee name: _____________________________________

Employee code: ______________________________________

	Skills desired	Skill score	Training required
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15

Status	Score
Good	3
Satisfactory	2
Improvement	1
Nil	0

Training needs analysis done by:

Name: ___________________________________

Signature: ________________________________

Date: _________________________

Example of documentation template for Management Representative

The following document templates (tool kits) are provided totally complimentary, free of charge to use as a starting point for Management Representative. As each business is different, additional documents or revisions would be required to meet your organization’s specific needs, requirements, context, risk profile, etc. If after reading through all of these documents, you feel like you still need a consulting partner to help you develop your new documents – Contact Us. We’re always looking for interesting new clients and projects.

1. Document Change Request

Requestor:                                                        DCR No.:

Department:                                                     Date:

Document code:                                              Rev. No:

Document title:                                               Rev. Date:

NATURE OF CHANGE REQUIRED:

INSTEAD OF:

SIGNATURE OF REQUESTOR

CHANGE REVIEW REMARKS:

APPROVED BY

CHANGE INCORPORATED IN DOCUMENT: Yes /No

MASTER COPY UPDATE: Yes /No

Revision No: Revision Date:

SIGNATURE OF MANAGEMENT REPRESENTATIVE

Iss.No./Date: XX/XX.XX.XXXX
Rev.No/Rev.Date: XX/XX.XX.XXXX

2. New Document Request

Requester: NDR No.:

Department: Date:

DOCUMENTED REQUIRED:

DETAILS:

SIGNATURE OF REQUESTOR

NAME OF THE ORIGINATOR:

DECISION: ACCEPTED /REJECTED

APPROVED BY

REQUIREMENTS INCORPORATED IN DOCUMENT: Yes /No

MASTER LIST UPDATE: Yes /No

Document No:

Revision No:

Revision Date:

SIGNATURE OF MANAGEMENT REPRESENTATIVE

Iss.No./Date: XX/XX.XX.XXXX
Rev.No/Rev.Date: XX/XX.XX.XXXX

3. Document Control and Issue Register

Sl No.	Description of Document	Doc No.	Issue# / Rev #	Copy #	Issued To	Receivers’s Sign	Date	Status of Doc.	Withdrawal	Remarks
Managing Director



Management Representative



Operational Manager


QA/QC Department



Maintenance



Sales



Procurement



Human Resource



HSE

4. Quality System Documents Amendment Register

Sl No.	Description of Document	Doc No.	Current			Previous			Amendments	Remarks
Sl No.	Description of Document	Doc No.	Issue#	Rev #	Date	Issue#	Rev #	Date	Details of changes	Remarks

5. Annual Internal Audit Plan/Annual MRM Plan

Month / Week

JAN

FEB

MAR

APRIL

MAY

JUN

JUL

AUG

SEP

OCT

NOV

DEC

III

Prepared by

Approved by

Date

Iss.No./Date: xx/xx.xx.xxxx
Rev.No/Rev.Date: xx/xx.xx.xxxx

6. Annual Internal Audit Schedule

Department	Auditee	Auditor	Scope of the audit	Time	Date







Prepared By:			Approved By:
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date: xx/xx.xx.xxxx

7. Internal Audit Report

Date: –		Dept:			Auditor:		Auditee:
+ Obs: Positive Observation		OI: Opportunity for Improvement			MN – NC: Minor Non Conformance		MJ – NC: Major Non Conformance
Sr. No.	Standard Reference	Audit Questionnaire	Audit Questionnaire		Compliance Type
					+ Obs	OI	MN – NC	MJ – NC





Auditors Signature:				Auditee : Signature:
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date: xx/xx.xx.xxxx

8. Internal audit summary report

To:
Cc:
From:
Date:
Audit Description:
Executive Overview
Audit Objective and Scope
Audit Team
Criteria
Positive Observations
Repeated Findings
Audit Findings
Recommendations
Corrective Action Status
Signature Management Representative:	Date:
Iss.No./Date: xx/xx.xx.xxxx
Rev.No/Rev.Date: xx/xx.xx.xxxx

9. Non Conformance Report

Originator		NCR Number
Reference		NCR Date
Department		Auditee
N. C Findings : MAJOR/ MINOR

Signature & Date of Orignator:	Auditee signature
Root cause and correction of non-conformance
Root Cause :

CORRECTION:

CAR Agreed By: Name/ Title
Signature & Date:
Corrective Action:

QA/QC Manager : Sign & Date	Target date of completion :
Follow-up audit: Verification of correction and corrective action

QA/QC Manager : Sign & Date
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date: xx/xx.xx.xxxx

10. NonConformities Tracking Sheet

Sl No.	Departments/Areas	Non Conformance Report	NCR Number	Type	Date	Auditees	Auditors	Status	MR Sign.

11 MANAGEMENT REVIEW MEETING MINUTES

Management Review Meeting Agenda

Quality Policy
Quality Objectives & Targets
Effectiveness of actions resulting from previous management reviews
Results of Audits
Changes that could affect the quality management system, including changes to legal and other applicable requirements (such as industry standards)
Analysis of customer satisfaction, including customer feedback
Process performance
Results of Risk assessment
Status of corrective and preventive actions
Analysis of supplier performance
Review of analysis of product conformity, including nonconformities identified after delivery or use
Recommendations for improvement

Venue:
Date:
Period:
Time:
PARTICIPANTS







Absentees :
Management Representative:
Sno.	Topic discussed	Review of Topic	Decision on Implementation	Improvement / Corrective action	Responsibility	Time frame
A.	Follow-up actions from previous management reviews

B.	Results of Audits
	Internal Quality Audit
	External Quality Audit
C	Customer Audit
	Customer Feedback
	Customer Complaints
D	Results of risk assessment


E	Process performance and product conformity
	Monthly Outgoing Inspection Report
	Continual Improvement Plan
F	Status of Corrective & Preventive Action

G	Supplier Performance

H	Changes that could affect the Quality Management
	Organizational Structure
	Customer specific requirements
	Legal & other applicable requirements
	Certification Council
I	Achievement of Objectives and Targets
	Quality Policy
	Quality Objective
	Staff Training needs review
J	Review of all elements of the entire Quality System
	Review of Quality Manual
	Organization Chart
	Calibration Frequency review
	Timely Invoicing Review
	Resources needs for personnel
	Product related to customer requirements
	Recommendations for improvement
	Effectiveness of all elements in the entire quality management system and its processes
Prepared by Approved by
Issue No. / Date : xx/ xx-xx-xxxx Rev. No. / Date : xx/ xx-xx-xxxx

12. Action Plan

Sl.No.	What	Where	Which	How many How much	Why do (Cause)	How to do (Method)	Who	When

















Prepared by: Approved by:
Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date: xx/xx.xx.xxxx

13) NC Closure – Verification Checklist

NC #	Date:
Root Cause Analysis Addressed?	Yes/ NO
Actions Taken to Correct Nonconformity Addressed?	Yes/ NO
Actions Taken to Minimize Recurrence Addressed?	Yes/ NO
Documents Revised As Part of Corrective Action?	Yes/ NO
Training Performed As Part of Corrective Action?	Yes/ NO
Training Effectiveness Determined?	Yes/ NO
Corrective Action Closed & Determined to be Effective?	Yes/ NO

Record Objective Evidence
Include revised documents, training dates, closure dates, effective dates and any other relevant information

Name of the Management Representative:

Signature of the Management Representative :

Date:

14) QMS Self Assessment form

1	Is your department working efficiently?
1a	If not why?
1b	What is recommendation?
2	Do you have enough resources?
2a	If not describe.
3	Is the applicable section of the QMS is relevant within your department?
3a	If not describe.
4	Is there any customer complaints due to your/department failure?
4a	If yes, what corrective action taken? Is it effective?
5	What is your recommendation for overall improvement of the QMS?
	Date of analysis:
	Name of customer:
	No of order carried out during last 3 months:

15) Record of Management of Change

Process/Process Area: Initiated or Identified by:					MOC No.
					Date:
CHANGE IN THE SYSTEM NEEDED
Proposed or identified change				Present Process/Function

MOC PROCESS
Change in Organizational Structure Yes No Change in Critical Supplier Yes No Change in Key Personnel or Essential Personnel Yes No Change in Management System Procedure Yes No Others, Please Specify:
Reviewe by :		Management Representative (MR)		Date:
RISK ASSOSCIATED WITH THE CHANGE
#	Risk		Impact on	Significance	Action/Elimination/ Mitigation
				High (H) Medium (M) Low (L)
1
2
3
4
5
Note: High = Required change in QMS, process, technology, knowledge, personnel or supply chain partners/process, time constrains Medium = Required implementation, resources planning/allocation, or training but possible within the set time frame; Low = none of H or M
RECOMMENDED / NECESSARY ACTIONS FOR THE MITIGATION OF RISK
#	Action			Target	Responsibility
1
2
3
4
5
APPROVED BY:				Date:
MOC IMPEMENTATION
#	Action			Status	Comments
1
2
3

16. Risk Assessment & Management

Cross Functional Team

RA Performed on:

Prepared by:

Risk Assessement & Management

Approved by:

Define the process:

Doc No.: SOS / MR / 18

Process Function

Potential Failure Mode

Potential Effect(s) of Failures

s e v

C l a s s

Potential Cause(s)/Mechanism(s) of Failures

O c c u r

Current Process Controls Prevention

Current Process Controls Detection

D e t e c t

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Action Results

Requirements

Action Taken

S e v

O c c

D e t

R P N

Issue / Rev. No.:

Date:

Summary of Changes:

Reason for Revision

17. Contingency Planning

Sl. No.

Process / Function in the Organization

Identified Critical activity in the Organization

Outcome of Risk Assessment – Identified Risk

Impact

Contingency Plan

Responsibility / Authority

Internal Communication Control

External Communication Control

Remarks

What

When

Where

Why

Who

How

How much?

18. Corrective and/or Preventive Action Request

REQUEST RAISED FOR

CORRECTIVE ACTION
PREVENTIVE ACTION

TO:

PAR/CAR NO:

DATE:

Incident Details:	Identified by: (source/employee)	Potential Risk/Opportunity

Action Planned:	Responsibility & Target (for action):		Action Taken:

Action Details:
Completed by (Signature & Date)		Verified & Accepted by: (MR/Top Management)

Follow-up:	Effectiveness:		Status: Closed / New CAR/PAR

Action Details:
Completed by (Signature & Date)		Verified & Accepted by: (MR/Top Management)

19. Quality Performance Analysis Report

Quality Objectives

S. NO	Department	Objectives	Target	Current Status	Remark

S. NO	Performance Parameter	Current Status	Remark
2	Review of Quality Policy:
3	Effectiveness of action resulting from previous MRM:
4	Result of Audits: a) Internal Audit: b) External Audit:
5	Changes that could affect the quality management system, including changes to legal and other applicable requirements:
6	Customer Complaints:
7	Customer Satisfaction Survey Data:
9	Order Summary (Process Performance):
10	Internal and External issues, Needs and Expectation of Interested parties,
11	Results of Risk Assessments and Contingency planning:
12	Product/service Non conformances, including non conformances identified after delivery or use:
13	Status of Corrective & Preventive actions: (NCR / NCMR)
14	Supplier Performance Summary:
15	Resource needs: a) Quality Improvements: b) Recommendation for Improvement:

Prepared by:		Approved by:
Name:		Name:
Sign:		Sign:
Date:		Date:

20 Monthly Key Performance Indicator (KPI)

Department :				Month/Year :		__________ / 20____
Person responsible :

Sr. No	Task	Completion			Remarks
		Target	Actual








Approved By : _________________		Verified By : ___________________

21. Standards User Register

S. No	Description of the Standards	Name	Received on	Returned on	Sign	Remarks


























Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

22 Minutes of Meeting

Subject:
Venue:
HSE Regulation:
Minutes taken by:
Attendee:	Department:	Signature:











Distribution List:
Agenda:

Issues	Actions
Issues	Actionee	Due Date	Status

Example of documentation template for Design and Development

The following document templates (tool kits) are provided totally complimentary, free of charge to use as a starting point for Design and Development dept. As each business is different, additional documents or revisions would be required to meet your organization’s specific needs, requirements, context, risk profile, etc. If after reading through all of these documents, you feel like you still need a consulting partner to help you develop your new documents – Contact Us. We’re always looking for interesting new clients and projects.

1.Design & Development – Cross Functional Team

Job No. : Record No. :

Product :

The following are the team members participating in the design and development process

Sl. No.	Name	Process	Qualification	Experience

2. Design & Development Plan

Sr. No.	Stages	Source	Requirements	Responsibility	Target date of completion	Actual date of completion	Review
1	Design & development plan	Customer & Standard requirements
2	Input	Customer PO / Contract Review
		Applicable Statutory requirements (Legal)
		Required Product Specification
		API Spec requirements Scope
		Size & Material designations
		Service Conditions
		Methodology , assumptions and formulae documentation
		Requirements for Manufacturing process
		Risk Assessment & Management
		Resources
		API Monogram requirements
3	Output	Applicable Statutory requirements
		Methodology, assumptions and formulae documentation
		Material qualification requirements
		Dimensions and Design acceptance criteria
		Identification of products of components deemed critical to design
		Special characteristics for safe and proper use
		Risk Assessment & Management
		Appropriate information for Purchasing
		Requirements for Manufacturing Process
		Verification, Validation and Testing processes
		API Monogram requirements
4	Review	Product Requirements
		Legal Requirements
		Dimensional requirements and Critical components
		Material Requirements
		Purchasing Requirements
		Manufacturing Requirements including Traceability
		Testing Requirements
		Verification and Validation requirements
		Risk assessments
		API Monogram requirements
5	Verification & Final Review	Alternate calculations
		Inspection Reports
		Surface NDE Reports (
		Hardness Test Report
		Dimensional Report
6	Validation & Approval	Test
7	Control of Changes	Engineering changes
8	API Monogram Marking	API Monogram Marking procedure

3. Design & Development input

SR.NO	DESIGN INPUTS REQUIREMENTS	RESPONSIBILITY	DESIGN INPUTS
1	Customer Requirements Customer PO
2	Contract review
3	Applicable Statutory requirements
4	Required Product Specification
	1)
	2)
	3)
	Service conditions
5	Material Designations
6	Methodology , assumptions and formulae documentation
7	Historical performance and other information derived from previous similar designs
8	Requirements for Manufacturing process
9	Testing & verification
10	Validation
11	Results of Risk Assessments
12	Availability of Raw Material
13	Resources applicable for manufacturing
14	Special resources required
15	API Monogram Requirements

4. Design & Development Review

Doc No. :	PRODUCT:		Planned Dt.
PROJECT NO.:	Part No. :		Actual Dt.
CUSTOMER:			Rev No.
* After contract review
PARTICIPANTS	DEPARTMENT	SIGNATURE





POINTS CONSIDERED FOR THE REVIEW
Review on Customer specific requirements identified in the contract review checklist
Product description
Methodology, assumptions and formulae documentation
Results of calculations
Historical Performance and information derived from previous Similar design
Verification of dimensional measurements and acceptance criteria
Are tolerances compatible with accepted manufacturing standards
Identify products or Components deemed critical to Design
Special characteristics for safe and proper use
Requirements for Manufacturing process
Traceability requirements
Technical Requirements including test methods, requirements for Verification and acceptance criteria
Functional requirements including validation of product manufactured and acceptance criteria
Is the specified test sampling size and / or frequency feasible
If required, has customer approval been obtained for test equipment
Environmental condition, in which the test is to be performed.
Availability of Machines/Equipments/Tools
Availability of Procedures / other documentation
Applicable Statutory requirements
Results of Risk Assessments
Any other points to be considered?

Prepared by	Reviewed by	Approved by
Name	Name	Name
Sign	Sign	Sign
Date	Date	Date

5. Design & Development output

Record No. : Part No. :
Job No : Date & Rev No. :
Description :

SR.NO	DESIGN OUTPUT REQUIREMENTS	RESPONSIBILITY	DESIGN OUTPUTS
1	Product Specification
2	Applicable Statutory requirements
3	Methodology, assumptions and formulae documentation including Historical performance and other information as applicable
4	Drawings including the Design acceptance criteria
5	Identification of products of components deemed critical to design
6	Special characteristics for safe and proper use
7	Bill of Materials
8	Results of Risk Assessments
9	Approved list of Critical Suppliers, Selection of suppliers
10	Raw Material
11	Requirements for Manufacturing process, Testing & verification
12	Quality & Production Plan
13	Traceability marking like Heat number & Serial number
14	Machining as per Requirements
15	Welding Operations in accordance with SOS approved WPSs
16	NDE(MT, Hardness testing and PT on ring grooves)
17	Verification, Validation & Testing Methods
18	API Monogram requirements
19	Availability of resources – Machines/Equipments
20	Procedures / Work Instructions/ Operational Control Procedure (Procedures)
22	Special resources required

Prepared by	Reviewed by	Approved by
Name	Name	Name
Sign	Sign	Sign
Date	Date	Date

6. Design Verification and Final Review

Part No.:		Part Name:	Record No.:		Date & Rev No.:
Job / WO / Project No.:			Sl. No.:
DESIGN VERIFICATION
S.No.	REQUIREMENT	INPUT	OUTPUT		REMARKS
1	Required Product Specification,
2	Material Designations
3	Methodology , assumptions and formulae documentation
4	Requirements for Manufacturing process
5	Testing & verification
6	API Monogram Requirements
TECHNICAL VERIFICATION
S.No.	STAGE DESCRIPTION	SPECIFICATION	VERIFICATION METHOD		RESULT	REMARKS
1	Raw Material Inspection
2	Material Composition
3	Material Mechanical Properties
4	NDT
5	Finished component verification
6	NDT
7	Special Compliance
Prepared by:		Checked by:		Approved by:
Name:		Name:		Name:
Sign:		Sign:		Sign:
Date:		Date:		Date:
Issue / Rev No.: 02 / 03 Rev. Date:14-11-2019

7. Transmittal

*From:*		*Department:*
Project:
*To:*		*Department:*

Please find attached herewith the following documents for:
	[ ] I (information)		[ ] A (Approval)		[ ] C (Construction)
	[ ] N (With our comments)		[ ] R (Revision)		[ ] N (With our comments)
	[ ] T (To be returned with your comments)		[ ] V (Revised according to your comments)		[ ] X __________________
No	Documents transmitted:	Description			Revision	No. Copies	Format
1							.dwg / .pdf
2							.dwg / .pdf
3							.dwg / .pdf
4							.dwg / .pdf
5							.dwg / .pdf
6							.dwg / .pdf
7							.dwg / .pdf
8							.dwg / .pdf
9							.dwg / .pdf
10							.dwg / .pdf
11							.dwg / .pdf

*Please return a signed copy of the present transmittal for acknowledgement.*
Signature:
Department:				Department:
Iss.No./Date:xx/xx.xx.xxxx
Rev.No/Rev.Date:xx/xx.xx.xxxx

8. Design & Development validation

Part No.:	Job / WO / Project No.:	Record No.:
Part Name:	Sl. No.:	DATE & REV No.:
Description	Observations and review	Reviewed by	Remarks
1. Prototype tests
Performance test certificate
Mechanical test
Hardness test
2. Functional and/or operational tests of production products
Pressure test certificated
Any other test
3. Tests specified by industry standards and/or regulatory requirements
Reference Standard:
Test description
4. Field performance tests and reviews
Field performance test result if any

Prepared by:	Checked by	Approved by:
Name:	Name:	Name:
Sign:	Sign:	Sign:
Date:	Date:	Date:
Issue: xx, Rev. No.: xx Issue / Rev. No Date: xx-xx-xxxx / xx-xx-xxxx

9. Document Progress Register (DPR)

ID	Department	Discipline	Documents transmitted	Description	Rev.	Sheet	Format	Remark

























Iss.No./Date: xx/xx.xx.xx
Rev.No/Rev.Date: xx/xx.xx.xx

10. Design Change Note

REQUEST NUMBER:		DRAWING / SPEC / TECHNICAL DOCUMENT NO.:		DATE:
CHANGE NUMBER:		DRAWING / SPEC / TECHNICAL DOCUMENT DESCRIPTION:
DESCRIPTION OF CHANGE:
REASON FOR REQUEST:
1. CUSTOMER
2. PROCESS IMPROVEMENT
3. PRODUCT IMPROVEMENT
4. SUPPLIER
5. ERROR
STOCK DISPOSITION:
1. USE “AS-IS”
2. SCRAP
3. REWORK
4. N/A
COPIES OF ECN TO BE DISTRIBUTED TO:
1. PURCHASING
2. QUALITY ASSURANCE
3. OPERATIONS
4. STORES
5. QUALITY CONTROL
6. OTHER (SPECIFY)
COMMENTS:
CHANGE EFFECTS THE FOLLOWING WORK ORDERS:
Requested By:	Reviewed by:		Approved By:
Iss.No./Date: xx/xx.xx.xx Rev.No/Rev.Date: xx/xx.xx.xx

Example of documentation template for sales department

The following document templates (tool kits) are provided totally complimentary, free of charge to use as a starting point for for sales dept. As each business is different, additional documents or revisions would be required to meet your organization’s specific needs, requirements, context, risk profile, etc. If after reading through all of these documents, you feel like you still need a consulting partner to help you develop your new documents – Contact Us. We’re always looking for interesting new clients and projects.

1. INQUIRY REGISTER

S. No	Client name	Quotation Ref No.

















Prepared by		Reviewed by
Name		Name
Sign		Sign
Date		Date
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date: 00/–	*Enquiry status can be On hold / Under discussion / Regret

2. Job Register

S.No	PO.No	Job Delivered on
	.




















Prepared by		Reviewed by
Name		Name
Sign		Sign
Date		Date
Iss.No./Date: 01/30.12.2017 Rev.No/Rev.Date: 00/–

3. Contract Review

Customer:
Enquiry No. :	Date
Quotation Ref:	Date:
P. O. No. :	PO Received Date : Confirmation on :

A) Technical Requirement Review:

Sr. No	Review Points	Review Comments
1	Nature of work
2	Scope of work specified by customer
3	Is drawing, specification and standards mentioned in drawing are available and are latest.
4	Product specification
5	Material
6	Manufacturing requirements
7	Testing/Inspection requirements
8	Order within SOS capacity. Any outsourcing required.
9	Monogram requirements

B) Commercial Requirement

Sr. No	Review Points	Review Comments
1	Price
2	Payment Terms and Conditions
3	Freight
4	Any Other Points

C) Legal Requirements

Sr. No.	Legal Requirements	Review comments

D) Risk Assessment

Sr. No.	Risk Identified	Review comments

E) Job Specific Training Requirements

Sr. No.	Training Requirements	Review comments

Order Accepted : Yes / No	Date :
Contract review done By:	Approved By:

4. Verbal Inquiry / Order Form

ENQUIRY NO.:	RECEIVING DATE:
CLIENT:	CLOSING DATE:
	DRAWINGS RECEIVED:	Yes / No
CONTACT:	INQUIRY THROUGH:	Verbal
TELEPHONE:		Email
FAX:
DESCRIPTION OF JOB:

RECEIVED BY	QUOTED:	Yes / No
NAME:	QUOTED TERMS & CONDITIONS (IF YES):
DESIGNATION:
SIGNATURE:	AMOUNT :
	COMPLETION:
REMARKS:
Iss.No./Date: xx/xx.xx.xxxx
Rev.No/Rev.Date:xx/xx.xx.xxxx

5. Customer Satisfaction feedback

*For ORGANIZATION use only*
Customer Information
Company
Job Number
Starting Date	PO Number
Invoice Date	Date
Customer Representative	Contact

*Please fill the following to determine the level of satisfaction about work done:*
*For customer use*		Satisfaction Level
S.No	Concerns	Encircle one					Remarks
		Poor—————->Good
1	How was the enquiry been responded?	1	2	3	4	5
2	Had quotation submitted within your desired time?	1	2	3	4	5
3	How cost effective our quote is in meeting your expectation?	1	2	3	4	5
4	Has the work been done as per the scope defined in the quotation?	1	2	3	4	5
5	How well did the Commercial Department coordinated with you?	1	2	3	4	5
6	In case of any damages reported to ORGANIZATION, were actions taken promptly?	1	2	3	4	5
7	How do you find the quality of our service?	1	2	3	4	5
8	Are you satisfied with the level of documentation provided to you?	1	2	3	4	5
9	Has the work been completed within the agreed delivery date?	1	2	3	4	5
10	Would you like to continue with ORGANIZATION for a similar job again?	1	2	3	4	5
*	Please provide suggestions for our quality improvement (Space provided below)
*Customer comments & Signature*
*For ORGANIZATION use only*		Total Score Obtained			Percentage		Remarks By HOD
Total Customer Satisfaction Score		/50			/100

Reviewed by:		Issued with invoice by:
Iss.No./Date: xx/xx.xx.xxxx
Rev.No/Rev.Date: xx/xx.xx.xxxx

6. Customer Satisfaction Analysis Report

Date of analysis:
Name of customer:
No of order carried out during last 6 months:

1	Is customer satisfied with our overall performance?	A	B	C
2	Is customer happy with our communication?	A	B	C
3	Is customer satisfied with our quality of work/product?	A	B	C
4	Is customer satisfied with the delivery?	A	B	C
5	Is customer happy with our pricing? (No of order lost during the last 3 months from this customer)	A	B	C
6	Is the customer satisfied with our resources? (Personnel, Machineries & Equipment, Finance etc.)	A	B	C
7	Is the customer satisfied with our communication channel? (If no, specify)	A	B	C
8	Is the customer happy with our hospitality and service when they visit us?	A	B	C
9	Is the customer happy with our qualification and experience?	A	B	C
10	Is the customer happy with our safety procedures and safety practice?	A	B	C
11	Is the customer happy with our Quality System & Procedures?	A	B	C
12	Is customer happy with our service after sale?	A	B	C
	Final Score	A	B	C

Analysis carried out by:	Reviewed by:	Analysis carried out by:
Name:	Signature and Date:	Name:
Signature and Date	Designation:	Signature and Date

7. Marketing visit logbook

S.No.	Date	Company	Meeting with	Sales Executive	Results	GM Review





























Iss.No./Date: xx/xx.xx.xxxx
Rev.No/Rev.Date:xx/xx.xx.xxxx

8. Annual Customer Feed Back Evaluation and Analysis

From January ____ to Decemeber ____
Sl NO	Customer		No. of jobs excuted	No, if jobs for which the feed back was taken	Average Satisfication (%)

















	Sub Total

Reviewed by:		Verified by:
Name:		Name:
Date:		Date:
Iss.No./Date: 01/04.12.2017 Rev.No/Rev.Date: 01/01.08.2018

9. Weekly Customer Visit Plan / Report

S.No.	Date	Company	Person contacted	Contact number	Job no if any	Quotation No.	P.O. No.	Remarks/Status





















Iss.No./Date: xx/xx.xx.xxxx
Rev.No/Rev.Date:xx/xx.xx.xxxx

10. Production Monitoring & Delivery Status Record

Sl no	Received Date	Job No	Inquiry No	Description	Customer	PO No	PO Date	Completion as per PO	Actual Date of Completion	Delay/ Gain Time	Remarks



















Prepared by						Reviewed by
Name						Name
Sign						Sign
Date						Date
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date: xx/xx.xx.xxxx-

11. Documentation Checklist

JOB ORDER #

1	INQUIRY	(VERBAL/WRITTEN)

2	COSTING SHEET

3	WRITTEN QUOTE

4	CUSTOMER PURCHASE ORDER

5	CUSTOMER SUPPLIED MATERIAL NOTE(SRV)

6	ROUTE SHEET/PRODUCTION PLAN

7	DRAWING (IF REQUIRED)

8	WPS (IF REQUIRED)

9	MATERIAL CERTIFICATES

10	INSPECTION REPORTS

11	DELIVERY NOTE

12	INVOICE REQUEST

13	CONTRACT REVIEW

14	EMAIL CORRESPONDANCES

CHECKED BY			VERIFIED BY
NAME, SIGN & DATE			NAME, SIGN & DATE
Iss.No./Date: xx/xx.xx.xxxx
Rev.No/Rev.Date: xx/xx.xx.xxxx

12.0 Customer Requirement Review

Sr. No	Review Points	Comment
1
2
3
4
5
6
7
8
9
10
	Customer Representative	Reviewed by (Organization)
Name
Sign
Date

13.0 Product Technical Delivery Conditions

Customer Name:
Enquiry No:	Date:
Enquiry Ref: Email / ~~Verbal~~	Contact person:

Sr. No	Product Description	Technical Specifications Proposed
1
2
3
4
5
6
7
8
9
10
	Proposed By	Reviewed by
Name
Sign
Date

API Specification Q1 Internal Audit checklist

API Specification Q1 Audit checklist

The following checklist can be used for both internal audits as well as Gap Analysis tools.

	API Specification Q1 Internal Audit checklist
4.0	Quality Management System Requirements
4.1	Quality Management System
4.1.1	General
1	How does the organization plan, establish, document, implement, and maintain a quality management system at all times in accordance with the requirements of this specification for the product provided within the scope defined by the organization?
2	How does the organization measure the effectiveness the quality management system by the requirements of API Specification Q1?
3	How does the organization improve upon the quality management system by the requirements of API Specification Q1?
4.1.2	Quality Policy
1	Has the organization established a Quality policy for its commitment to quality?
2	How does the organization ensure that Quality policy is appropriate to the organization?
3	Does the organization’s top management review the quality policy periodically?
4	How does the organization ensures that Quality policy is appropriate to the organization?
5	How does the organization ensure that Quality policy supports its strategic direction?
6	How does the organization ensures that Quality policy is the basis for the development of quality objectives?
7	How does the organization ensure that Quality policy is communicated, understood, implemented, and maintained within the organization?
8	How does the policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system?
9	How does oes the policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system?
4.1.3	Quality Objectives
1	Are the Quality objectives measurable?
2	How does the management ensure that quality objectives meet product and customer requirements?
3	How does the management ensure that quality objectives are established at relevant functions and levels within the organization?
4	How does the Management Representative ensure the initiation of action(s) to minimize the likelihood of the occurrence of nonconformities?
5	Are the Quality objectives measurable?
6	Is the Quality objectives measurable?
7	How does the management ensure the planning of the quality management system is carried out to meet the requirements of API Specification Q1?
4.1.4	Planning
4.1.4.1	General
1	How is the planning of the quality management system performed?
2	How is the planning of the quality management system performed?
3	How does the organization identify external and internal issues relevant to the organization’s long-term or overall objectives and goals?
4	How does the organization determine relevant interested parties and their requirements for the quality management system?
5	How does the organization determine the sequence and interaction between the processes of the quality management system?
6	How does the organization determine and manage the criteria and methods needed for the effective operation and control of quality management system processes?
7	How does the organization identify quality objectives, including actions, resources, responsibilities, and timeframe, and how results are monitored and evaluated?
8	How does the organization address identified risks?
9	How does the organization address identified opportunities for improvement?
10	How does the organization identify key personnel?
4.1.4.2	Exclusions
1	Has the organization claimed any exclusions to any sections of API Q1 specification Q1 and will the exclusions be limited to the following sections of this specification: — 5.4, Design — 5.6.4, Validation of Processes — 5.6.7, Externally Owned Property — 5.8, Testing, Measuring, Monitoring, and Detection Equipment (TMMDE)
2	Where any exclusions are claimed, are the justifications documented?
3	How does the organization ensure that Excluded activities do not affect the organization’s ability, or responsibility, to provide products that satisfy customer and legal requirements?
4	Has the organization ensured that there are no claims to exclusion of activities addressed by this specification, including outsourced activities, if an organization performs them?
4.1.5	Communication
4.1.5.1	Internal
1	How does the management ensure that appropriate communication processes are established within the organization?
2	How does the organization establish processes to ensure that the results of analysis of data are communicated at relevant levels and functions within the organization?
3	How does the organization establish processes to ensure that the results of analysis of data are communicated at relevant levels and functions within the organization?
4.1.5.2	External
1	Has the organization established and implemented the process for communicating with external organizations, including customers?
2	How does the communication process address the execution of inquiries, contracts, or order handling and amendments?
3	How does the organization determine and understand the requirements throughout contract execution and product realization?
4	How does the communication process address the provision of product information, including nonconformities?
5	How does the communication process address feedback and customer complaints?
6	How does the organization communicate quality plans and subsequent changes to those plans?
7	How does the organization communicate changes and associated risks?
4.2	Management Responsibility
4.2.1	General
1	How does the top management demonstrate leadership and commitment to the establishment, implementation, maintenance, and improvement of the quality management system?
2	How does the top management ensure that quality objectives are established at relevant functions and levels within the organization?
3	How does the top management provide the resources needed for the quality management system?
4	How does the top management engage and support personnel in the implementation and maintenance of quality management systems?
5	How does the top management assign responsibilities and authorities for ensuring the processes achieve intended outputs?
4.2.2	Responsibility and Authority
1	Are the responsibilities, authorities, and accountabilities of personnel within the scope of the Quality Management System defined, documented, and communicated throughout the organization?
4.2.3	Management Representative
1	Has the top management appointed and maintained a member of the organization’s management as a Management Representative?
2	Has the top management ensured that the quality management system conforms to the requirements of this specification?
3	How does the Management Representative ensure that processes needed for the quality management system are established, implemented, and maintained?
4	How does the Management Representative report to top management on the performance of the quality management system and any need for improvement?
5	How does the organization determine and allocate the resources needed to implement, maintain, and improve the effectiveness of the requirements of the quality management system?
6	How does the organization determines and allocate the resources needed to implement, maintain, and improve the effectiveness of the requirements of the quality management system?
4.3	Organization Capability
4.3.1	Resources and Knowledge
4.3.1.1	Resources
1	How does the organization determine and allocate the resources needed to implement, maintain, and improve the effectiveness of the requirements of the quality management system?
4.3.1.2	Knowledge
1	How does the organization determine the knowledge needed to provide continued operation of its processes?
2	How does the organization determine the knowledge needed to achieve ongoing conformity of products?
3	How does the organization maintain this knowledge and make it available?
4.3.2	Human Resources
4.3.2.1	Personnel Competence
1	Does the organization ensure that its personnel whose responsibilities fall within the scope of the quality management system are competent?
2	Is there a documented procedure addressing personnel competence that the organization shall maintain?
3	Does the procedure include how required competencies are identified and documented?
4	Does the procedure include how required education, training, experience, or other actions to achieve competence are identified?
5	Does the procedure include an evaluation of the effectiveness of actions taken to acquire competencies?
6	Does the procedure include criteria and methods for assessing, maintaining and, re-assessing competencies?
7	Does the procedure include personnel responsible for assessing competency?
8	Are the records of personnel competence maintained?
4.3.2.2	Training
1	How does the organization develop and maintain a procedure for training?
2	How does the organization identify the content and frequency of training required?
3	How does the organization address the provision of quality management system training?
4	How does the organization address the provision of job training including personnel awareness of the relevance and importance of their activities and how they contribute to the achievement of the organization’s quality objectives ?
5	How does the organization provide customer-specified training and/or customer-provided training, when required?
6	How does the organization evaluate of effectiveness of training?
7	How does the organization identify the required training records?
8	Does the organization maintain appropriate records of personal training?
4.3.3	Work Environment
1	How does the organization determine, provide, manage, and maintain the work environment needed to achieve conformity of the product?
2	Does the work environment include a) buildings, workspace, and associated utilities; b) process equipment (both hardware and software) ; c) supporting services (e.g. transport, communication, information systems); and d) conditions under which work is performed such as physical, environmental, or other factors.
4.4	Documentation Requirements
4.4.1	General
1	Does the quality management system documentation include the scope of the quality management system that identifies the products covered, including justification for any exclusions?
2	Does the quality management system documentation includes statements of quality policy and quality objectives?
3	Does the quality management system documentation include the identification of legal and other applicable requirements to which the organization claims compliance that is needed to achieve product conformity?
4	Does the quality management system documentation include identification of how the quality management system addresses each requirement of API Q1?
5	Does the quality management system documentation include identification of processes that require validation?
6	Does the quality management system documentation include documented procedures established for the quality management system?
7	Does the quality management system documentation include documents and records to ensure the effective planning, operation, and control of its processes and compliance with specified requirements?
4.4.2	Procedures
	Are all procedures referenced within API Specification Q1 describing the organization’s method for performing an activity and documented, implemented, and maintained for continued suitability?
4.4.3	Control of Documents
1	Does the organization maintain a documented procedure for the identification, distribution, and control of internal documents required by the quality management system and API Specification Q1, including revisions, translations, and updates?
2	Does the procedure specify responsibilities for approval and re-approval?
3	Does the procedure specify the review and approval for adequacy prior to issue and use?
4	Does the procedure specify the review for continued suitability and revision(s) as necessary?
5	Does the procedure specify the identification of changes and current revision status?
6	Does the procedure specify the legibility and identification of documents?
7	Does the procedure identify the controls needed to ensure that the documents required by the quality management system are available where the activity is being performed?
8	How are obsolete documents removed from all points of issue or use, or otherwise identified to ensure against unintended use if they are retained for any purpose?
9	How are Procedures, work instructions, and forms required by the quality management system controlled?
4.4.4	Use of External Documents in Product Realization
1	Does the organization maintain a documented procedure for the control of documents of external origin required for product realization and used by the organization, including API or other external specifications?
2	Does the procedure address identification and documentation of required documents?
3	Does the procedure address access and distribution of required documents, including relevant versions?
4	Does the procedure address the integration of requirements into product realization and any other affected processes?
5	Does the procedure address the process for identifying when changes to required documents have occurred, including addenda, errata, and updates?
6	Does the procedure address the integration of applicable changes?
7	Does the organization maintain a documented procedure to identify the controls and responsibilities needed for records?
4.5	Control of Records
1	Are records, including those originating from outsourced activities, established and controlled to provide evidence of conformity to requirements and the organization’s quality management system?
2	How does the organization address record identification, collection, legibility, correction, storage, protection from unintended alteration, damage, loss, retrieval, retention time, and disposition?
3	How does the organization address record identification, collection, legibility, correction, storage, protection from unintended alteration, damage, or loss, retrieval, retention time, and disposition?
4	Are the records retained for a minimum of ten years or as required by the customer, legal, and other applicable requirements, whichever is longer?
5.0	Product Realization
5.1	Contract Review
5.1.1	General
1	Does the organization maintain a documented procedure for the review of requirements related to the provision of products?
2	Does the procedure address the determination of requirements, review of requirements; and changes to requirements?
5.1.2	Determination of Requirements
1	How does the organization determine the requirements specified by the customer?
2	How does the organization determine the legal and other applicable requirements?
3	How does the organization determine the requirements not stated by the customer but considered necessary by the organization for the provision of the product?
4	Where the customer provides no documented statement of the requirements, is the customer requirements confirmed by the organization and records maintained?
5.1.3	Review of Requirements
1	How does the organization review the requirements related to the provision of products?
2	Is this review conducted before the organization‘s commitment to deliver the product to the customer?
3	How does the organization ensure that requirements are identified and documented?
4	How does the organization ensure that requirements differing from those previously identified are resolved?
5	How does the organization ensure that the organization can meet the documented requirements?
6	Where contract requirements are changed, how does the organization ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements?
7	Are the records of the results of the review, including resulting actions, maintained?
5.2	Planning
1	Has the organization identified and planned the processes and documents needed for product realization?
2	How does the organization plan for required resources and work environment management?
4	How does the organization plan for the product and customer-specified requirements?
5	How does the organization plan for the legal and other applicable requirements?
6	How does the organization plan for the contingency?
7	How does the organization plan for the design requirements?
8	How does the organization plan for the required verification, validation, monitoring, measurement, inspection, and test activities specific to the product and the criteria for acceptance?
9	How does the organization plan for management of change (MOC)?
10	How does the organization plan for the records needed to provide evidence that the product realization conforms to requirements?
11	Is the output of planning documented?
12	Is the output of planning updated as changes occur?
13	Are the plans maintained in a structure suitable for the organization‘s method of operations?
5.3	Risk Management
5.3.1	General
1	Does the organization maintain a documented procedure to identify and control risks associated with product delivery and product quality?
2	Does the procedure address risk identification and assessment techniques?
3	Does the procedure address risk assessment tools and their application?
4	Is the criteria to determine risk severity including potential consequences of product failure established?
5	Does the procedure address risk mitigation actions?
6	Does the procedure address the assessment of remaining risk?
7	Does the organization maintain a documented procedure for identifying, verifying, safeguarding, preserving, maintaining, and controlling customer-supplied property, including intellectual property and data, while under the control of the organization?
5.3.2	Risk Assessment
5.3.2.1	Product delivery
1	Does Risk assessment associated with product delivery include facility/equipment availability including maintenance?
2	Does Risk assessment associated with product delivery include supplier delivery performance and material availability/supply?
5.3.2.2	Product Quality
1	Does the Risk assessment associated with product quality include delivery of nonconforming products?
2	Does the Risk assessment associated with product quality include the availability of competent personnel?
5.3.2.3	Changes Impacting Product Quality
1	If any changes can negatively impact the quality of the product, does the organisation perform a risk assessment associated with product quality?
2	Is a risk assessment associated with product quality performed when there are changes in the organizational structure?
3	Is a risk assessment associated with product quality performed when there are changes in key personnel?
4	Is a risk assessment associated with product quality performed when there are changes in the supply chain of critical products, components, or activities?
5	Is a risk assessment associated with product quality performed when there are changes to the management system scope or procedures?
6	Is a risk assessment associated with product quality performed when there are changes to the organization’s capability to perform the process(es) required for product realization?
5.3.3	Contingency Planning
1	Has the organization determined any contingency plan based on assessed risk?
2	Does the contingency plan include actions required to reduce the effects of disruptive incidents?
3	Does the contingency plan include the identification and assignment of responsibilities and authorities?
4	Does the contingency plan include internal and external communication controls?
5	Is the contingency plan documented, communicated to the relevant personnel, and updated as needed?
5.3.4	Records
	Are the Records of risk assessment and management including actions taken maintained?
5.4	Design
5.4.1	General
1	In case the organization is responsible for the design of products, have the requirements of 5.4 applied? (The design requirements of 5.4 is not applied if the product is in production activities, servicing, storage, distribution, or logistics)
5.4.2	Design Planning
1	Does the organization maintain a documented procedure to plan and control the design process?
2	Does the procedure identify the plans, including plan updates, used for design?
3	Does the procedure identify the design stages?
4	Does the procedure identify the resources, responsibilities, authorities, and their interfaces?
5	Does the procedure identify the review, verification, and validation activities necessary to complete each design stage?
6	Does the procedure identify the requirements for a final review of the design?
7	Does the procedure identify the review and approval requirements for design changes?
8	When design activities are outsourced or performed at different locations within the organization, does the procedure identify the controls required to ensure that the designs meet the requirements of 5.4 Design?
9	When design and development are outsourced, how does the organization ensure the supplier meets the requirements of 5.5.1.7 outsourcing?
5.4.3	Design Inputs
1	How does the organization identify and review the Inputs for adequacy, completeness, lack of ambiguity and lack of conflict?
2	How are any issues identified are addressed?
3	Does the Inputs include functional and technical requirements?
4	Do the Inputs include customer-specified requirements?
5	Do the Inputs include requirements provided from external sources, including API product specifications?
6	Do the Inputs include environmental and operational conditions?
7	Do the Inputs include methodology, assumptions, and formulae documentation?
8	Do the Inputs include historical performance and other information derived from previous similar designs?
9	Do the Inputs include legal requirements?
10	Do the Inputs include consequences of potential product failure when required by legal requirements, industry standards, customers, or deemed necessary by the organization?
11	Are the records of design inputs maintained?
5.4.4	Design Outputs
1	How does the organization document its output to allow verification against the design input requirements?
2	Does the output meet the input requirements for design?
3	Does the output provide information for purchasing, production, inspection, testing and servicing as applicable?
4	Does the output identify or refer to design acceptance criteria (DAC)?
5	Does the output include identification of, or reference to, products and/or components deemed critical to the design?
6	Does the output include the results of applicable calculations?
7	Does the output specify the characteristics of the product that are essential for its safe and proper use?
8	Are the Records of design outputs maintained?
5.4.5	Design Review
1	Are Design Reviews performed at suitable stages?
2	Are reviews performed to evaluate the suitability, adequacy, and effectiveness of the results of design and development stages to meet specified requirements?
3	Are reviews performed to identify any problems and propose necessary actions?
4	Do participants in such review(s) include representatives of functions concerned with the design stage(s) being reviewed?
5	Are the records of the results of the review(s) and any necessary actions maintained?
5.4.6	Design Verification and Final Review
1	To ensure that the design outputs have met the design input requirements, how does the organization ensure that design and development verification and a final review are conducted and documented as identified within the organization’s procedure?
2	Are the records of design verification, any necessary actions and the final review maintained?
5.4.7	Design Validation and Approval
1	Are Design and development validation performed in accordance with the organization’s procedure?
2	How does the organization ensure that the Design validation of the resulting product is capable of meeting the specified requirements?
3	When possible does the organization ensure that validation is completed prior to the delivery of the product?
4	How does the organization ensure that the completed design is approved after validation?
5	How does the organization ensure that Competent individual(s) other than the person or persons who developed the design approve the final design?
6	Are records of the design and development validation, approval, and any necessary actions maintained?
5.4.8	Design Changes
1	How are Design changes identified?
2	How does the organization ensure that the changes are reviewed, verified, and validated, as appropriate, and approved before implementation?
3	How does the organization ensure that the review of design changes includes an evaluation of the effect of the changes on the product and their constituent parts in affected stages of product realization, as well as the product already delivered?
4	Does the review of design changes include an evaluation to determine if customer notification is required when design changes negatively affect the specified performance capability of the product?
5	How does the organization ensure that the design and development changes, including changes to design documents, are in accordance with the organization’s procedure?
6	Are the records of design and development changes, reviews of those changes, and any necessary actions maintained?
5.5	Purchasing
5.5.1	Purchasing Control
5.5.1.1	Procedure
1	Does the organization maintain a documented procedure for the purchase of products, components, and/or activities required for product realization?
2	Does the procedure determine the critical products, components, and/or activities?
3	Does the procedure address the initial evaluation and selection of suppliers?
4	Does the procedure address the use of identified risk to determine the initial assessment method of the supplier’s capability for critical purchases?
5	Does the procedure address the type and extent of control applied to the supply chain for critical products, components, or activities?
5	Does the procedure address criteria, scope, frequency, and methods for re-evaluation of suppliers?
6	Does the procedure address the identification of approved suppliers and the scope of approval?
7	Does the procedure address identification of customer-specified suppliers and suppliers limited by proprietary, and/or legal requirements when 5.5.1.3 (Initial Supplier Evaluation – Critical Purchases – Customer Specified, Proprietary, and/or Legal Limited) applies?
5.5.1.2	Initial Supplier Evaluation—Critical Purchases
1	For the purchase of critical products, components or activities, does the initial evaluation of suppliers (not previously approved) address the scope of supply, and are site-specific for each supplier?
2	Does the initial Supplier Evaluation for Critical Purchases include the verification of the supplier’s quality management system implementation and conformity to the quality system requirements specified for suppliers by the organization?
3	Does the initial Supplier Evaluation for Critical Purchases include verification of the type and extent of control applied by the supplier, internally and to their supply chain, to meet the organization’s requirements?
4	Does the initial Supplier Evaluation for Critical Purchases include an assessment of the supplier’s capability to meet the organization’s specified requirements by one or more of the following based on identified risk?
5	Does the initial Supplier Evaluation for Critical Purchases include performing an on-site assessment to verify that relevant product realization processes are being performed in accordance with process controls, and are effective in achieving conformity to requirements, performing an on-site evaluation of relevant activities?
6	Does the initial Supplier Evaluation for Critical Purchases include performing a remote assessment to verify that relevant product realization processes are being performed in accordance with process controls and are effective in achieving conformity to requirements?
6	Does the initial Supplier Evaluation for Critical Purchases include performing inspection, testing, or verification of relevant characteristics of a received product?
7	How does the organization ensure that the suppliers of critical purchases with high-risk severity identified by the organization for which an on-site assessment is not performed, the assessment of the supplier’s capability includes performing a remote assessment and performing inspection, testing, or verification?
8	When remote assessment is performed, does it include verification of objective evidence through real-time audio/visual observation of required activities and documentation using information and communication technology?
9	Does the evaluation of a supplier be performed in accordance with the requirements of this section for any additions to a supplier’s scope of approval or change from an approved site to a new site of supply?
5.5.1.3	Initial Supplier Evaluation – Critical Purchases – Customer Specified, Proprietary, and/or Legal Limited
1	For the purchase of critical products, components, or activities where the supplier is specified by the customer or involves proprietary and/or legal requirements does the initial evaluation include a) verification of the supplier’s quality management system implementation and conformity to the quality system requirements specified for suppliers by the organization and/or the customer’s requirements; and b) identifying how the supplied product, component or activity conforms to specified requirements.
2	How does the organization ensure that the scope of approval for customer-specified suppliers shall be limited to the relevant customer contract when assessment per 5.5.1.2, Item c) has not been performed?
5.5.1.4	Initial Supplier Evaluation—Noncritical Purchases
1	For the purchase of noncritical products, components, or activities that impact product realization or the final product, do the criteria for evaluation of suppliers by the organization meet the requirements as that of initial Supplier Evaluation for Critical Purchases or satisfy one of the following a) verification that the supplier’s quality management system conforms to the quality system requirements specified for suppliers by the organization; b) assessment of the supplier to meet the organization’s purchasing requirements; c) assessment of the product upon delivery or activity upon completion
5.5.1.5	Supplier Reevaluation
1	For previously approved suppliers of products, components, or activities, has the organization determined the supplier reevaluation frequency based on identified risk and supplier quality performance?
2	For the re-evaluation of suppliers of critical products, components or activities, have the requirements of 5.5.1.2 been applied?
3	For the re-evaluation of suppliers of critical products, components or activities for customer-specified suppliers and suppliers limited by proprietary, and/or legal requirements, have the requirements of 5.5.1.3 been applied?
4	For the re-evaluation of suppliers of noncritical products, components, or activities that impact product realization or the final product, have the requirements of 5.5.1.4 been applied?
5.5.1.6	Records
1	Are the Records of the results of all evaluations including objective evidence and any necessary actions arising from the evaluations maintained?
2	Are the Records of identification of approved suppliers, customer-specified suppliers, and suppliers limited by proprietary, and/or legal requirements shall be maintained?
5.5.1.7	Outsourcing
1	How does the organization maintain responsibility for product conformance to specified requirements, including applicable API product specifications, associated with product realization?
2	How does the organization maintain responsibility for product conformance to specified requirements, including applicable API product specifications or other external specifications?
3	Are the Records of outsourced activities maintained and include evidence of conformity?
5.5.2	Purchasing Information
1	How does the organization ensure the adequacy of specified purchasing information before their communication with the supplier?
2	Are the Purchasing information provided to the supplier documented and describes the product or activity to be purchased, including acceptance criteria?
3	Does the Purchasing information describe requirements for approval of the supplier’s procedures, processes, and equipment?
4	Does the Purchasing information describe the applicable version of specifications, drawings, process requirements, inspection instructions, traceability, and other relevant technical data?
5	Does the Purchasing information describe requirements for the qualification of supplier’s personnel?
6	Does the Purchasing information describe requirements for the qualification of the supplier’s personnel?
7	Does the Purchasing information describe the requirements for approval of product release?
8	Does the Purchasing information describe if the organization or its customer intends to perform verification at the supplier’s premises, the intended verification arrangements?
5.5.3	Verification of Purchased Products, Components or Activities
5.5.3.1	General
1	Does the organization maintain a documented procedure defining the verification for determining whether purchased products components or activities conform to specified purchase requirements?
5.5.3.2	Critical Purchases
1	For critical products, components or activities, has the organization established the procedure for verification?
2	Does the procedure address the review of the organization’s required documentation from the supplier?
3	Does the procedure address the verification that the applicable versions are used when specifications, drawings, process requirements, inspection instructions, traceability requirements, and other relevant technical data are specified?
4	Does the procedure address the inspection, testing and/or verification requirements including methods, frequency, and responsible party.?
5	Does the organization determine the methods, frequency, and responsible party based on identified risk and supplier quality performance?
5.5.3.3	Noncritical Purchases
1	In accordance with the organization’s documented procedure, does the organisation verify Non-critical products, components or activities?
5.3.3.4	Records
1	Are the Records of verification activities and evidence of conformity to specified requirements maintained?
5.6	Control of Product Realization
5.6.1	General
1	Does the organization maintain a documented procedure that describes controls associated with the product realization?
2	In the procedure, has the organization determined and implemented the manufacturing acceptance criteria (MAC)?
3	Has the organization identified and documented of processes critical to product realization?
4	Does the procedure address the implementation of the product quality plan, when applicable?
5	Does the procedure address conformance of design requirements and related changes, when applicable?
6	Does the procedure address the availability and use of product realization equipment and TMMDE, unless it has been excluded?
7	Does the procedure address the use of applicable work instructions?
8	Does the procedure address process control documents?
9	Does the procedure address the implementation of monitoring and measurement activities?
10	Does the procedure address implementation of product release including applicable delivery and post-delivery activities?
11	Does the procedure address review and control of product realization changes, required approvals, and records?
5.6.2	Quality Plans
1	When required by contract, has the organization developed a quality plan that specifies the processes of the quality management system (including the product realization processes) and the resources to be applied to a product?
2	Does the Quality plan address the product description or scope of the quality plan?
3	Does the Quality plan address the required processes and documentation, including required inspections, tests, and records, for conformance with requirements?
4	Does the Quality plan address the identification of outsourced activities and reference to control?
5	Does the Quality plan address the identification of each procedure, specification, or other document referenced or used in each activity?
6	Does the Quality plan address the identification of the required hold, witness, monitor, and document review points?
7	Are the quality plans and any revisions to it are documented and approved by the organization?
8	Are the quality plans and any revisions communicated to the customer?
5.6.3	Process Control Documents
1	Has the organization documented process controls?
2	Does the process control include or refer to requirements for verifying conformance with applicable quality plans, API product specifications, customer requirements, and/or other applicable product standards/codes;
3	Does the process control include or refer to instructions and acceptance criteria for processes, tests, and inspections?
4	Where applicable, Does the process control include or refer to the customer’s inspection hold, witness, monitor, and document review points?
5.6.4	Validation of Processes
1	Does the organization validate processes when the resulting output cannot be verified by subsequent monitoring or measurement, and consequently, deficiencies become evident after the product has been delivered or are in use?
2	Does validation demonstrate the ability of these processes to achieve planned results?
3	Do only the processes specified in a product specification require validation for the applicable product?
4	Does the organization validate the following process: — nondestructive examination (NDE)/nondestructive test (NDT); — welding; — heat treating; and — coating and plating (when identified by the product specification or by the organization as critical to product performance).
5	Does the organization have a documented procedure for the validation of processes, including the methods used for review and approval?
6	Does the procedure include the required equipment?
7	Does the procedure include the qualification of personnel?
8	Does the procedure include the use of specific methods, including identified operating parameters?
9	Does the procedure include the identification of process acceptance criteria?
10	Does the procedure include the requirements for records?
11	Does the procedure include the revalidation?
12	Does the organization need to maintain evidence that the requirements of 5.6.4 Validation of process have been satisfied if it outsources a process that requires validation?
5.6.5	Identification and Traceability
1	Has the organization established and maintained identification throughout product realization, including applicable delivery and post-delivery activities?
2	Has the organization identified the traceability requirements as specified by the organization, the customer, and/or the applicable product specifications?
3	Has the organization maintained a documented procedure for identification and traceability while the product is under the control of the organization?
4	Does the documented procedure address the methods of identification?
5	Does the documented procedure address when required, information needed for traceability?
6	Does the documented procedure address the requirements for maintenance and/or reapplication of identification and/ or traceability?
7	Does the documented procedure address the actions required to address loss of identification and/or traceability?
8	Are the Records of traceability maintained?
5.6.6	Inspection/Test Status
1	Does the organization have a documented procedure for identifying inspection and/or test status throughout product realization, indicating product conformity or nonconformity?
5.6.7	Externally Owned Property
1	Does the organization maintain a documented procedure for controlling externally (including customer) owned property that is incorporated into the product while the property is under the organization’s control?
2	Does the Externally owned property include intellectual property and data that are not publicly available?
3	Does the procedure address identification, verification, safeguarding, preservation, maintenance; and reporting loss, damage, or unsuitability for use to the external owner?
4	Are the Records for the control and disposition of externally owned property maintained?
5.6.8	Preservation of Product
1	Does the organization maintain a documented procedure for describing the methods used to preserve the product and constituent parts throughout product realization and delivery?
2	Does the procedure address identification and traceability marks?
3	Does the procedure address storage, including the use of designated storage areas or stock rooms?
4	Does the procedure address the assessment of conditions at intervals specified by the organization?
5	Does the procedure address transportation;?
6	Does the procedure address handling?
7	Does the procedure address packaging?
8	Does the procedure address Protection?
9	Are the records of the results of assessments maintained?
5.6.9	Inspection, Testing, and Verification
5.6.9.1	General
1	Does the organization maintain a documented procedure for inspection, testing and /or verification of the product to confirm that requirements have been met?
2	Does the procedure address in-process inspection, testing, and/ or verification methods and their application?
3	Does the procedure address final inspection, testing, and/or verification methods and their application?
4	Are the records created and retention?
5.6.9.2	In-process Inspection, Testing, and Verification
1	Does the organization inspect, test, and/or verify products at planned stages as required by the quality plan, process control documents and/or documented procedures?
2	Are the evidence of conformity with the acceptance criteria maintained?
5.6.9.3	Final Inspection, Testing, and Verification
1	Does the organization perform final inspection, testing, and/or verification of the product in accordance with the quality plan, process control documents, and/or documented procedures to determine and document conformity of the finished product to the specified requirements?
2	Unless performed by an automated system, do personnel other than those who performed or directly supervised the product realization perform final acceptance inspection at planned stages of the product realization process?
5.6.9.4	Records
1	Are the Records of all required inspection, testing, verification, and final acceptance maintained?
5.6.10	Preventive Maintenance
1	Does the organization maintain a documented procedure for preventive maintenance of equipment used for product realization?
2	Does the procedure address the requirements for the type of equipment to be maintained, frequency of Preventive Maintenance and Responsible personnel?
3	Are the Records of preventive maintenance maintained?
5.7	Product Release
1	Has the organization maintained a documented procedure to address the release of products to the customer?
2	How do the organization ensure that the release shall not proceed until the planned arrangements have been satisfactorily completed?
3	How does the organization ensure that it releases products that conform to requirements or that are authorized under concession?
	Are the records maintained to enable identification of the individual releasing the product?
5.8	Testing, Measuring, Monitoring, and Detection Equipment (TMMDE)
5.8.1	General
1	How does the organization determine the testing, measuring, monitoring, and detection requirements and the TMMDE needed to provide evidence of conformity to those requirements?
2	Does the organization ensure that TMMDE owned and maintained by the organization, employee-owned equipment, and TMMDE from other sources (e.g. third-party, proprietary, and customer-owned) used to provide evidence of product conformity and/or monitor process parameters identified by the organization that impact product conformance are controlled.?
3	Are TMMDE calibrated at specified intervals?
4	When the specified interval is based on the date of first use, is the date of first use documented?
5.8.2	Procedure
1	Does the organization maintain a documented procedure for the control of TMMDE?
2	Does the procedure include requirements for the specific equipment type?
3	Does the procedure address unique identification?
4	Does the procedure address calibration status?
5	Does the procedure address traceability to international or national measurement standards?
6	Where no such standards exist, is the basis used for calibration recorded?
7	Does the procedure address the calibration method and acceptance criteria?
8	Does the procedure address the frequency of calibration, and when the calibration interval begins?
9	Does the procedure address documentation of the calibration measurements before adjustment and measurements after any adjustments during calibration?
10	Does the procedure address actions taken to prevent unintended use of TMMDE identified as out-of-calibration, beyond calibration interval, or not in-service?
11	Does the procedure address when the TMMDE is found to be out of calibration, an assessment of the validity of previous measurements and actions to be taken on the TMMDE and product, including maintaining records and evidence of notification to the customer if suspect product has been shipped?
12	Does the procedure address the use of third-party, proprietary, employee-owned, and customer-owned TMMDE?
13	Does the procedure address the maintenance?
14	Does the procedure address suitability for the planned monitoring and measurement activities?
5.8.3	Equipment
1	Are the TMMDE are calibrated?
2	Are the TMMDE calibration status identifiable by the user prior to and during use?
3	Have the TMMDE safeguarded from adjustments or modifications that would invalidate the measurement result or the calibration status?
4	How are the TMMDE protected from damage and deterioration during handling, maintenance, and storage?
5	How does the organization ensure that TMMDE is used under environmental conditions that are suitable for the calibrations, inspections, measurements, and tests performed?
6	How does the organization ensure that when used in the testing, monitoring, measurement, or detection of specified requirements, the ability of computer software to satisfy the intended application are confirmed prior to initial use and reconfirmed, as necessary?
5.8.4	TMMDE Equipment from Other Sources
1	When TMMDE is third-party, proprietary, or customer-owned, how does the organization confirm the equipment is in calibration prior to use? (When limited by customer, contract, or licensing agreement, the requirements of 5.8.2, Item c), 5.8.2, Item d), 5.8.2, Item e), 5.8.2, Item f), 5.8.2, Item j), and 5.8.2, Item k) shall not apply.)
5.8.5	Records
1	Has the organization maintained a registry of the identified TMMDE that includes a unique identification, specific to each piece of equipment?
2	Are the Results of calibration recorded and maintained?
3	When calibration of the third-party, proprietary, and customer TMMDE to the requirements of 5.8 is limited by customer, contract, or licensing agreement, do the organization maintain records of the limitations imposed?
5.9	Control of Nonconforming Product
5.9.1	Procedure
5.9.1.1	General
1	Does the organization maintain a documented procedure addressing the controls and related responsibilities and authorities for nonconforming products during product realization and after delivery?
5.9.1.2	Nonconforming Product During Product Realization
2	For addressing nonconforming products identified during product realization, does the procedure include product identification and controls to prevent unintended use or delivery?
3	How does it address the detected nonconformity?
4	How does it address taking action to preclude its original intended use or delivery?
5	How does it address authorizing its use, release, or acceptance under concession by the relevant authority and, where applicable, by the customer?
5.9.1.3	Nonconforming Product After Delivery
1	How does the procedure address identifying, documenting, and reporting nonconforming products?
2	Does the procedure include the analysis of nonconforming product, provided the product or documented evidence supporting the nonconformity is available to facilitate the determination of the cause?
3	How does the procedure address taking action appropriate to the effects, or potential effects, of the nonconformity?
4	Does the procedure include authorizing its use or acceptance under concession by relevant authority and, when required, by the customer?
5.9.2	Nonconforming Product
	Does the organization address nonconforming products by performing one or more of the following: a) repair or rework with the subsequent inspection to meet specified requirements; b) re-grade for alternative applications; c) release under concession d) reject or scrap
5.9.3	Release of Nonconforming Product Under Concession
1	For the nonconforming product that does not satisfy manufacturing acceptance criteria (MAC), how does the organization ensure that its release under concession meets one of the following conditions: a) products continue to satisfy the applicable Design Acceptance criteria (DAC) and/or customer criteria; or b) the violated MAC are categorized as unnecessary to satisfy the applicable DAC and/or customer criteria; or c) the DAC is changed and the products satisfy the revised DAC and associated MAC requirements. When the DAC was previously agreed with the customer, the DAC change shall be authorized by the customer.
2	How does the organization ensure that the product not conforming to DAC or contract requirements is not released without customer authorization?
5.9.4	Customer Notification of Nonconforming Product
1	How does the organization notify customers of a product not conforming to DAC or contract requirements, that has been delivered?
2	Are records of such notification maintained?
5.9.5	Records
1	Are Records of nonconformities maintained?
2	Does the Records of nonconformities include the description of the nonconformity, subsequent actions taken, including concessions obtained, the rationale to support the release of the product under concession, and relevant authority?
5.10	Management of Change (MOC)
5.10.1	General
1	Do the organization maintain a documented procedure for MOC to maintain the integrity of the quality management system when changes occur?
2	Does the MOC procedure address the description of, and the need for, the change?
3	Does the MOC procedure address the availability and allocation of resources (including personnel)?
4	Does the MOC procedure address potential risks that may arise from implementing the change?
5	Does the MOC procedure address the review, approval, and implementation of the change?
6	Does the MOC procedure address notifications?
7	Does the MOC procedure address verification of the completion of MOC activities and impact on the QMS?
5.10.2	MOC Application
1	How does the organization use MOC for changes that may negatively impact the quality of the product?
5.10.3	MOC Notification
1	Does the organization notify relevant internal personnel of the change and associated risk?
2	When required by contract, does the organization notify the customer of the change and associated risk?
3	Are the MOC Notifications documented?
5.10.4	Records
1	Are the Records of MOC activities shall be maintained?
6.0	Quality Management System Monitoring, Measurement, Analysis, and Improvement
6.1	General
1	Have the organization planned and implemented the monitoring, measurement, analysis, and improvement processes needed to ensure conformity of the quality management system to the requirements of API Q1 specification and to continually improve the effectiveness of the quality management system?
2	Does the Quality management system monitoring, measurement, analysis, and improvement include the determination of applicable methods, including techniques for the analysis of data, and the extent of their use?
6.2	Monitoring, Measuring, and Improving
6.2.1	Customer Satisfaction
1	Does the organization maintain a documented procedure to measure customer satisfaction?
2	Does the procedure address the frequency and method of determining Customer satisfaction?
3	Does the procedure address the key performance indicators of customer satisfaction?
4	Are the records of the results of customer satisfaction information maintained?
6.2.2	Internal Audit
6.2.2.1	General
1	Does the organization conduct internal audits to ascertain whether the quality management system is implemented, maintained, and adheres to the specifications outlined in API Q1 as well as the organization’s quality management system requirements?
2	Does the organization maintain a documented procedure to define responsibilities for planning, conducting, and documenting internal audits?
3	Has the organization identified the audit criteria, scope, frequency, and methods of the internal audit?
4	Is the planning of audits conducted with consideration given to the outcomes of previous audits (both internal and external), the criticality of the audited process, and any modifications made to the quality management system?
5	Does the organization ensure that all processes of the quality management system claiming conformity to the requirements of API Q1 specification are audited at least every 12 months?
6	Is the time between audits of each part of the quality management system ensured not to exceed 12 months when the entire quality management system is not audited as one consolidated audit?
7	Do audits for processes performed by the organization, which are identified as critical to product realization, involve observing the activity being conducted and assessing whether it complies with the specified requirements?
6.2.2.2	Performance of Internal Audit
1	Are the Audits performed by competent personnel independent of those who performed or directly supervised the activity being audited to ensure objectivity and impartiality of the audit process?
2	Are records of Internal audits maintained?
3	Do the records provide objective evidence that the quality management system is implemented and maintained?
6.2.2.3	Audit Review and Closure
1	How does the organization identify response times for addressing detected nonconformities?
2	How does the management responsible for the area being audited ensure that necessary corrections and corrective actions are undertaken as per requirements for corrective action?
3	Are the Records of internal audits maintained?
6.3	Analysis of Data
1	Does the organization maintain a documented procedure for the identification, collection, and analysis of data to demonstrate the suitability and effectiveness of the quality management system?
2	Does the analysis include data generated from monitoring and measurement, internal audits, audits by external parties, management reviews, and other relevant sources?
3	Does the data analysis output provide information relating to customer satisfaction, nonconformity to product requirements during product realization, process performance, supplier performance and achiving quality objectives?
4	Does it include the nonconformities and product failures identified after delivery or use, provided the product or documented evidence is available to facilitate the determination of the cause?
5	Does the organization use data to evaluate where continual improvement of the effectiveness of the quality management system can be made?
6.4	Improvement
6.4.1	General
1	Does the organization continually improve the effectiveness of the quality management system by evaluating, selecting, and implementing opportunities for improvement through quality objectives, internal audit, data analysis, corrective action, and management review. ?
6.4.2	Corrective Action
1	Does the organization maintain a documented procedure to handle nonconformities, including those arising from customer complaints, and to initiate corrective actions both internally and with suppliers?
2	Are the Corrective actions appropriate to the effect(s) of the nonconformity encountered?
3	Does the procedure address the criteria for determining when the corrective action process is initiated?
4	Does the procedure address reviewing the nonconformity?
5	Does the procedure address determining and implementing corrections?
6	Does the procedure address identifying the root cause of the nonconformity and evaluating the need for corrective actions?
7	Does the procedure address the implementing corrective action to reduce the likelihood that a nonconformity recurs?
8	Does the procedure address identifying the timeframe and responsible person(s) for addressing corrections and corrective action?
9	Does the procedure address the verification of the effectiveness of the corrections and corrective action taken?
10	Does the procedure address the updating risks and opportunities determined during planning?
11	Does the procedure address the MOC when the corrective actions require new or changed controls within the quality management system?
12	Does the procedure address evaluating similar, potential nonconformities and implementing action to reduce the likelihood of occurrence, as appropriate?
13	Are the Records of corrective action process activities maintained?
14	Do the Records identify the activities performed to verify the effectiveness of the corrective actions taken?
6.5	Management Review
6.5.1	General
1	Is the organization‘s quality management system reviewed at least every 12 months(not later than the end of the same calendar month as the prior year review) by the organization’s management?
2	Does the management review evaluate the quality management system’s continuing suitability, adequacy, and effectiveness?
3	Do the reviews include assessing opportunities for improvement, adequacy of resources and the need for changes to the quality management system, including the quality policy and quality objectives?
6.5.2	Input Requirements
1	Does the input to the management review include the status and effectiveness of actions resulting from previous management reviews?
2	Does the input to management review include the results of audits and audits of the organization by external parties?
3	Does the input to management review include changes that could affect the quality management system, including changes to legal and other applicable requirements(such as industry standards)?
4	Does the input to management review include changes that could affect the quality management system, including changes in external and internal issues that are relevant to the quality management system?
5	Does the input to the management review include an analysis of customer satisfaction?
6	Does the input to the management review include relevant feedback from customers and other interested parties?
7	Does the input to management review include process performance?
8	Does the input to the management review include the results of the risk assessment and the effectiveness of actions taken to address risks?
7	Does the input to management review include the status of corrective actions?
8	Does the input to the management review include the analysis of supplier performance?
9	Does the input to management review include a review of the analysis of product conformity, including nonconformities identified after delivery or use?
10	Does the input to the management review include actual performance compared with quality objectives?
11	Does the input to the management review include recommendations for improvement?
6.5.3	Output Requirements
1	Does the output from the management review include a summary assessment of the effectiveness of the quality management system?
2	Does the assessment include any required changes to the processes and any decisions and actions, required resources, and any improvement to products in meeting customer requirements?
3	Do the Top management reviews and approves the output of management reviews?
4	Has the organization applied the API Monogram to products developed, maintained, and operated at all times in a quality management system conforming to API Q1?
5	Are the records of the management review maintained?
	Use of API Monogram by Licensees
A.4	Quality Management System Requirements
1	Has the organization applied the API Monogram to products developed, maintained, and operated at all times in a quality management system conforming to API Q1?
A.5	Control of the Application and Removal of the API Monogram
1	Does the Licensee ensure that Products that do not conform to API-specified requirements shall not bear the API Monogram
2	Has the Licensee developed and maintained an API Monogram marking procedure that documents the marking/monogramming requirements and any applicable API product specification(s) and/or standard(s)?
3	Has the organization applied the API Monogram to products developed, maintained, and operated at all times a quality management system conforming to API Q1.
4	Does the marking procedure define the method(s) used to apply the Monogram?
5	Does the marking procedure identify the location on the product where the API Monogram is to be applied?
6	Does the marking procedure require the application of the Licensee’s license number and date of manufacture of the product in conjunction with the use of the API Monogram?
7	Does the marking procedure require that the date of manufacture, at a minimum, be two digits representing the month and two digits representing the year (e.g. 05-12 for May 2012) unless otherwise stipulated in the applicable API product specification(s) or standard(s)?
8	Does the marking procedure require controls for the application of the additional API product specification(s) and/or standard(s) marking requirements, as applicable?
9	Is the API Monogram removed by the Licensee’s API Monogram marking procedure if the product is subsequently found to be out of conformance with any of the requirements of the applicable API product specification(s) and/or standard(s) and API Monogram Program?
10	Is the API monogram applied at the site for which the API Monogram license is issued?
11	Is the API Monogram removed in accordance with the Licensee’s API Monogram marking procedure if the product is subsequently found to be out of conformance with any of the requirements of the applicable API product specification(s) and/or standard(s) and API Monogram Program?
A.6	Design Package Requirements
1	Does the Licensee and/or applicant for licensing maintain a current design package for all of the applicable products that fall under the scope of each Monogram license?
2	Does the design package information provide objective evidence that the product design meets the requirements of the applicable and most current API product specification(s)?
3	Is the design package(s) made available during API audits of the facility?
A.7	Manufacturing Capability
1	Has facilities demonstrated the ability to manufacture equipment that conforms to API specifications and/or standards?
A.8	API Monogram Program: Nonconformance Reporting
1	As a customer do you report to API all problems with API monogrammed products using the API Nonconformance Reporting System available at http://compositelist.api.org/ncr.asp.

ISO 29001:2020 Internal Audit checklist

ISO 29001:2020 Audit checklist

The following checklist can be used for both internal audits as well as Gap Analysis tools.

	ISO 29001:2020 Checklist
Clause 4:	Context of the organization
4.1	Understanding the organization and its context
1	Has the organization determined the external and internal issues relevant to the Purpose & strategic direction of its QMS and that can affect its ability to achieve the intended results?
2	Does the organization monitor and review information about these external and internal issues?
3	While determining the internal and external issues has the organization considered positive and negative factors or conditions?
4	Was the understanding of the external context facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local?
5	Was the understanding of the internal context facilitated by considering issues arising from values, culture, knowledge and performance of the organization?
6	Does the organization retains documented information that demonstrates the understanding of its context?
4.2	Understanding the needs and expectations of interested parties
1	Has the organization determined the interested parties that are relevant to the QMS?
2	Has the organization determined the requirements of these interested parties relevant to the QMS?
3	Does the organization monitor and review the information about these interested parties and their relevant requirement?
4	Does the organization retains documented information that demonstrates the understanding of the needs and expectations of interested parties?
4.3	Determining the scope of the quality management system
1	Has the organization established the scope of its QMS?
2	Has the organization determined the boundaries and applicability of the QMS?
3	While determining the scope, has the organization determined the external and internal issues, requirements of relevant interested parties, product and services of the organization?
4	While determining Applicability, does the organization determine if it affects its ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction?
5	Does the scope state the types of products and services covered?
6	Does the scope give justification for any requirements that the organization determines and is not applicable to the scope of its QMS?
7	Is the organization’s scope made available and maintained as a Documented Information?
8	When requested, does the organization advises interested parties of any requirements of this document that the organization determines are not applicable to the scope of its quality management system?
4.4	Quality management system and its processes
1	Has the organization established, implemented, maintained and continually improved its QMS?
4.4.1
1	Has the organization determined the processes needed for the QMS?
2	Has the organization determined the application of these process throughout the organization?
3	Has the organization determined the sequence and the interaction of these process?
4	Has the organization determined and applied the criteria and methods needed to ensure the effective operation and control of these processes?
5	Do these methods include the monitoring, measurement and related performance indicator?
6	Has the organization determined the resources needed for the organization?
7	Has the organization ensured the availability of the resources needed for these processes?
8	Has the organization assigned the responsibilities and authorities for these processes?
9	Has the organization addressed the risk and opportunities associated with these processes?
10	Has the organization evaluated these processes and implemented any changes needed to ensure that these processes achieve its intended results?
11	Has the organization made improvement in its processes and its QMS?
4.4.2
1	Has the organization maintained documented information to support the operation of its processes?
2	Do the organization retain documented information as evidence that the processes have been carried out as planned?
4.4.3
1	Has the organization defined the extent of documented information required to meet relevant interested parties’ requirements?
Clause 5	Leadership
5.1	Leadership and commitment
5.1.1	General
1	Does the top management demonstrate leadership and commitment by taking accountability for the effectiveness of its QMS?
2	Has the top management ensured that the quality policy and quality objective are established?
3	Is the quality policy and quality objective compatible with the context and strategic direction of the organization?
4	Has the organization integrated the requirements of QMS with the business processes?
5	Is the organization promoting the use of process approach and risk-based thinking throughout the organization?
6	Is the top management ensuring that the resources needed for the QMS are available?
7	Is the importance of the effectiveness of QMS and meeting QMS requirements communicated?
8	Does the top management ensure that the QMS is achieving its intended results?
9	Does Top Management engage, directs and supports the persons required to contribute to the effectiveness of the QMS requirements?
10	Is Top Management promoting improvements?
11	Is Top Management supporting other relevant management roles to demonstrate their leadership as it applies to their area of responsibilities?
5.1.2	Customer Focus
1	Does the Top Management demonstrate leadership and commitment by ensuring that customer and applicable statutory and regulatory requirements are determined, understood and are consistently meeting the requirements?
2	Are the risks and opportunities that can affect the conformity of products and services and the ability to enhance customer satisfaction are determined and addressed?
3	Is the focus of enhancing customer satisfaction maintained?
5.2	Policy
5.2.1	Establishing the Quality policy
1	Has the Top Management established, implemented and maintained a quality policy?
2	Is quality policy appropriate to the purpose and context of the organization and does it supports its strategic directions?
3	Does the Quality policy provide the framework for setting quality objective?
4	Does the Quality policy include the commitment to satisfy applicable requirements and to continually improvement of the QMS?
5.2.2	Communicating the quality policy
1	Is Quality policy maintained as documented information?
2	Is Quality policy communicated, understood and applied within the organization?
3	Is Quality policy appropriate and made available to the relevant interested parties?
5.3	Organizational roles, responsibilities and authorities
1	Has the Top management ensured that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization?
2	While assigning the responsibilities and authorities, do the top management ensure that the processes are meeting their intended results?
4	While assigning the responsibilities and authorities, do the top management ensure that there is the promotion of customer focus throughout the organization?
5	While assigning the responsibilities and authorities, do the top management ensure that performance of its QMS and opportunities for improvement are reported to them?
6	While assigning the responsibilities and authorities, do the top management ensure that integrity of QMS is maintained when changes to the QMS are planned and maintained?
7	Has the organization defined the relevant roles?
8	Has the organization maintained and retained documented information (record and procedure) covering responsibilities and authorities for these roles?
Clause 6	Planning
6.1	Actions to address risks and opportunities
1	While planning for QMS, does the organization considers the issues referred to in clause 4.1 and requirement referred to in clause 4.2?
6.1.1
1	Has the organization determined the risks and opportunities that have to be addressed so that QMS can achieve its intended results, enhance desirable effects, prevent, or reduce undesired effects and achieve improvement?
6.1.2
1	Has the organization planned actions to address these risks and opportunities?
2	Have these actions implemented and integrated into its QMS processes?
3	Has the organization evaluated the effectiveness of these actions?
4	Is the action proportionate to the potential impact on the conformity of product and services?
6.1.3
1	For managing risks and opportunities has the organization defined techniques, tools and their application for identification and assessment of risks and opportunities, and prevention and mitigation of risks?
2	For managing risks and opportunities has the organization identified relevant interested parties?
3	For managing risks and opportunities has the organization identified sources of risk and opportunity, areas of impacts, events and their causes, and their potential consequences?
4	For managing risks and opportunities has the organization analysed potential risk and opportunity by determining consequences and their likelihood?
5	For managing risks and opportunities has the organization evaluated risk and opportunity and develop controls for them?
6	For managing risks and opportunities has the organization applied appropriate risk treatments and opportunity realization plans?
7	Has the organization maintained and retained documented information (records and procedure) to support and demonstrate the management of risks and opportunities?
6.2	Quality objectives and planning to achieve them
6.2.1
1	Has the organization established quality objectives at relevant functions, levels and process needed for the QMS?
2	Are the quality objectives consistent with the quality policy?
3	Does the organization have quality objectives which are relevant to the conformity of product and services and enhancement of customer satisfaction?
4	Are the quality objective measurable and do they take account of applicable requirements?
5	Are the quality objectives monitored, communicated and updated as required?
6	Does the organization maintain documented information on the quality objectives?
6.2.2
1	For achieving quality objectives do the organization determines what will be done, what resources are required, who will be responsible, when will it be completed and how are the result to be evaluated?
6.3	Planning for change
1	While determining changes for the QMS, are changes carried out in a planned manner?
2	While planning for change, does the organization consider the purpose of the change and their potential consequence; the integrity of the QMS; the availability of resources; and allocation and reallocation of responsibilities and authorities?
3	How does the organization manage risks and opportunities associated with proposed changes?
4	Has the organization maintained and retained documented information (records and procedure) to manage the process of change?
7	Support
7.1	Resources
7.1.1	General
1	Has the organization determined and provided the resources needed for the establishment, implementing, maintaining and continually improvement of the QMS?
2	Has the organization considered the capabilities and constraints of existing internal resources?
3	Has the organization considered what needs to be obtained from external providers?
7.1.2	People
1	Has the organization determined and provided the persons required for effective maintenance of QMS and for operation and control of its processes?
7.1.3	Infrastructure
1	Has the organization determined and maintained the infrastructure needed for the operation of its processes and to achieve conformity of product and services?
7.1.3.1
1	Does the organization maintains and retains documented information of the processes for the determination and usage of its infrastructure to achieve conformity of products and services?
2	Does the documented Information addresses infrastructure to be maintained?
3	Does the documented Information addresses method of maintaining the infrastructure, including frequency and monitoring, that ensure infrastructure integrity to performance requirements?
4	Does the documented Information addresses outcome of maintenance, including applicable testing methods and acceptance criteria?
5	Does the documented Information addresses responsible personnel?
7.1.3.2
1	For service-related infrastructure, does the documented information addresses usage history, repairs or redress, modifications, remanufacturing, inspection, and test activities that allow direct verification for reuse of infrastructure?
2	For service-related infrastructure, does the documented information addresses list of critical spare parts required by the customer and/or technical requirements including those recommended by the original equipment manufacturer?
7.1.3.3
1	Does the organization applies risk-based maintenance which typically includes the concepts of preventive and predictive maintenance and /or reliability centred maintenance and /or mean time between failures and /or system, design and process failure mode and effects analysis and /or failure mode and criticality effects analysis and /or process control plans and/or others that are in context of the organization and its risks.
7.1.4	Environment for the operation of processes
1	Has the organization determined, provided and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services?
7.1.5	Monitoring and measuring resources
7.1.5.1	General
1	Has the organization determined and provided the necessary resources needed when monitoring and measuring are used to verify conformity to product and service requirement?
2	Are resources suitable for the type of monitoring and measurement activities undertaken?
3	Are resources maintained to ensure their continuing fitness?
4	Does the organization retains appropriate documented information (record) as evidence of fitness for the purpose of the monitoring and measurement resources?
5	Does the organization maintains documented information that defines the processes and controls employed to manage monitoring and measurement resources that meet the requirements?
7.1.5.2	Measurement traceability
1	Is there a requirement for measurement traceability?
2	Where measurement traceability is a requirement, is measurement equipment calibrated or verified at a specified interval or prior to use?
3	Is the calibration or done against measurements standards traceable to national or international standards?
4	Where no such standard is existing, are documented information retained for the basis used for calibration or verification?
5	Are the measuring equipment identified in order to determine their status?
6	Are the measuring equipment safeguarded from adjustments, damage or deteriorated that would invalidate the calibration and subsequent measurement results?
7	Does the organization maintains and retains documented information (records and procedure )demonstrating the conformance and measurement traceability of the measuring equipment used to determine product conformity to requirements? Does it includes some of the Common practice like a measuring equipment register?
8	Does documented information includes a unique identification, specific to each piece of equipment?
9	Does the organization determine and take appropriate action if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose?
10	Does the organization shall retain documented information of the action taken and of customer notification, if product(s) or services have been delivered?
7.1.6	Organizational knowledge
1	Does the organization determine the knowledge necessary for the operation of its processes and to achieve conformity of product and services?
2	Does the organization maintain this knowledge and make it available to the extent necessary?
3	While addressing changing needs and trends, does the organization considers its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates?
7.2	Competence
1	Does the organization determine the necessary competence of its employees whose work affects the performance and effectiveness of the QMS?
2	Does the organization ensure that its employees are competent on basis of appropriate education, training or experience?
3	Does the organization take applicable actions to acquire the necessary competence and evaluate the effectiveness of action taken?
4	Does the organization retain the appropriate documented information as evidence of competence?
7.2.1
1	Does the organization validates the competence to the risk level associated with the task?
2	Does the organization maintains documented information that defines the practices employed to manage competence requirements of personnel whose responsibilities influence the achievement of quality objectives?
3	Does it includes developing a competence model that defines a competence catalogue, proficiency levels, criteria for attaining and maintaining proficiency, and resulting competence profiles which can include technical interviews, assessments and online training.
7.3	Awareness
1	Does the organization ensure that the persons doing work under the organization’s control are aware of its quality policy, relevant quality objectives, their contribution to the effectiveness of QMS including the benefits of improved performance and the implications of not meeting QMS requirements?
2	How does the organization ensures that persons doing work under the organization’s control, including external provider’s personnel, are aware of specified regulated and customer quality requirements, risk mitigations and conformity assessment requirements related to their work.?
7.4	Communication
1	Does the organization determine the internal and external communication relevant to the QMS including on what it will communicate, when to communicate, with whom to communicate, how to communicate, and who communicates?
7.5	Documented Information
7.5.1	General
1	Does the organization’s QMS include documents required by ISO 9001:2015 and documents determined by the organization necessary for the effectiveness of the QMS?
7.5.2	Creating and updating
1	While creating and updating documented information, does the organization ensure it is appropriate in terms of identification descriptions?
2	While creating and updating documented information does the organization ensure that it is in proper format and in the correct media?
3	While creating and updating documented information, does the organization ensure that there are appropriate review and approval for suitability and adequacy?
7.5.3	Control of documented information
7.5.3.1
1	Does the organization control its documented information to ensure that it is available and suitable for use, whenever it is needed?
2	Is the documented information adequately protected?
7.5.3.2
1	Is the distribution, access, retrieval and use of documented information adequately controlled?
2	Is the documented properly stored and adequately preserved and it is legible?
3	Is there control of changes (e.g. version control)?
4	Are their adequate control in place for retention and disposition?
5	Is external origin documented information necessary for planning and operation of QMS appropriately identified and controlled?
6	Are records protected for unintended alterations?
7.5.3.3
1	The organization shall maintain documented information (Procedure) that defines the processes and controls used to meet the requirements of control of Documented Information?
2	When external specification requirements, including addenda, errata, and updates, are used in the design or manufacture of a product or service, does the organization maintain and retain documented information for the practices employed for the integration of these requirements into the related operating processes?
Clause 8	Operations
1	Does the organization plan, implement and control the processes needed to meet the requirement for the provision of product and services and to implement the action determined in clause 6?
8.1	Operation planning and control
1	Does the organization determine the requirements for the products and services?
2	Has the organization established criteria for the processes and acceptance of products and services?
3	How does the organization determine the resources needed to achieve conformity to the product and service requirements?
4	How does the organization implement controls of the processes in according with the criteria?
5	How does the organization determine, maintain and retain necessary documented information to have confidence that the processes have been carried out as planned and to demonstrate the conformity of products and services?
6	How does the organization control its planned changes and review the consequences of unintended changes?
7	How does the organization take action to mitigate any adverse effects of its unintended changes?
8	How does the organization ensure that outsourced processes are controlled?
9	When determining the requirements for the products and services, how does the organization take into account the customer’s scope?
10	Do the organization have documented information specifying the processes of the quality management system and the resources to be applied to a specific product, service, project or contract such as a quality plan, service quality plan or inspection and test plan?
11	How do the organization maintain documented information as the basis for operational process control and retain documented information to demonstrate conformance has established the controls?
12	How does the organization apply change management processes in respect to risks to the achievement of specified requirements and to the realization of improvement opportunities when planning the operations?
13	Has the organization established contingency plans as a risk treatment and in case it has does it include roles and responsibility for response, communication, immediate actions?
8.2	Requirements for products and services
8.2.1	Customer communication
1	Does the organization communicate with customers to provide information relating to products and services, handling enquiries, contracts or orders (including any changes)?
2	Does the organization obtain customer feedback relating to products and services including customer complaint?
3	Does the organization communicate with the customers relating to handling or controlling customer property?
4	Has the organization established requirements for contingency action, where required?
8.2.2	Determining the requirements for products and services
1	Has the organization determined the requirements for product and services to be offered the customer?
2	Are the requirements defined and does it includes applicable statutory regulatory requirements and those considered necessary by the organization?
3	Can the organization meet the claims for the product and services it offers?
8.2.3	Review of the requirements for products and services
8.2.3.1
1	Has the organization ensured that it has the ability to meet the requirements for products and services?
2	Has the organization conducted a review before committing to supply product and services?
3	Has the organization reviewed the requirements specified by the customer, including the requirements for delivery and post-delivery activities?
4	Has the organization reviewed the requirements not stated by the customers but necessary for the specified or intended use when know?
5	Has the organization reviewed the statutory & regulatory requirements applicable to the product and services and requirements specified by the organization?
6	Have the organization reviewed and resolved contract or order requirements differing for those previously defined?
7	When the customer does not provide a documented statement of their requirement, does the organization conform to the customer’s requirements before acceptance?
8.2.3.1.1
1	Does the organization maintain documented information (Procedure )that defines the process for the review of requirements related to the provision of products or services?
8.2.3.2
1	Does the organization retain documented information on the results of the review and on any new requirements for the products and services?
8.2.4	Changes to requirements for products and services
1	Does the organization ensure that the relevant documented information is amended and the relevant persons are made aware of the changed requirements when the requirements for the products and services are changed?
8.3	Design and development of products and services
8.3.1	General
1	Has the organization established, implemented and maintain a D&D process that is appropriate to the subsequent provision of product and services?
8.3.2	Design and development planning
1	In determining the stages and controls for D&D, has the organization is taken into consideration the nature, duration and complexity of D&D activities?
2	In determining the stages and controls for D&D, has the organization taken into consideration the required process stages including D&D reviews?
3	In determining the stages and controls for D&D, has the organization taken into consideration the D& D verification and validation activities?
4	In determining the stages and controls for D&D, has the organization taken into consideration the responsibilities and authorities involved in the D&D process?
5	In determining the stages and controls for D&D, has the organization taken into consideration the external and internal resources needed?
6	In determining the stages and controls for D&D, has the organization taken into consideration the need to control interfaces between persons involved in D&D?
7	In determining the stages and controls for D&D, has the organization taken into consideration the need for involvement of customer and user?
8	In determining the stages and controls for D&D, has the organization taken into consideration the requirements of the subsequent provision of product and services?
9	In determining the stages and controls for D&D, has the organization taken into consideration the level of the control expected for the D&D by customers and other relevant interested parties?
10	In determining the stages and controls for D&D, has the organization taken into consideration the documented information needed to demonstrate that design and development requirement has been met?
11	How does the organization ensures that ensure that the required activities for managing risks and opportunities are incorporated in the design development process?
12	Has the organization maintained documented information (Procedure) that defines the processes used to plan and control design and development activities of products and/or services?
8.3.3	Design and Development inputs
1	Has the organization determined the essential requirements for the specific types of products and services to be designed and developed?
2	Does the organization consider the following functional and performance requirements; statutory and regulatory requirements; standards or code of practices that the organization has committed to implement; information derived from previous design and development activities; potential consequences of failure due to the nature of the product and services?
3	Does the organization ensure that the inputs are adequate for D&D purpose, complete and unambiguous?
4	Does the organization resolve the conflicting D&D inputs?
5	Are documented information for D&D inputs retained?
6	Has the organization included environmental and safety conditions as the Performance requirements?
7	Has the organization considered outputs of process of managing risks and opportunities?
8.3.4	Design and development controls
1	Has the organization applied the necessary controls to D & D processes to ensure that the result to be achieved are defined?
2	Has the organization conducted a review to evaluate the ability of the results of D& D to meet the requirements?
3	Has the organization conducted the verification to ensure that D&D meet input requirements?
4	Has the organization conducted the validation to ensure that the resulting product and service meet the requirements of the specified application or intended use?
5	Has the organization taken necessary action on the problems determined during reviews, verification or validation activities?
6	Has the organization retained documented information on the above-mentioned activities?
8.3.5	Design and Development outputs

1	Does the organization ensure that D&D outputs meet the input requirements?
2	Does the organization ensure that D&D outputs are adequate for the subsequent processes for the provision of product and services?
3	Does the organization ensure that D&D outputs include (or has reference) monitoring and measuring requirements and acceptance criteria?
4	Does the organization ensure that D&D outputs specify the characteristics of the products and services that are essential for their intended use?
8.3.6	Design and Development changes
1	Has the organization identified, reviewed and controlled changes made during, or subsequent to the D & D of the product and services to ensure that there is no averse to the impact on conformity to requirement?
2	Has the organization retained the documented information on D&D changes, the result of reviews, authorization of the changes and the action taken to prevent adverse impact?
8.4	Control of externally provided processes, products and services
8.4.1	General
1	Does the organization ensure that the externally provided processes, products and services conform to the requirements?
2	Does the organization determine the controls needed when the product and services from the external providers are incorporated into their own product and services?
3	Does the organization determine the controls needed when the product and services from the external providers are provided directly to the customer by external providers?
4	Does the organization determine the controls needed when the process or part of the process is provided by the external providers?
5	Has the organization determined and applied the criteria for selection, evaluation, monitoring of performance and re-evaluation of external providers?
6	Has the organization retained the documented information of these activities and any action arising out or evaluation/re-evaluation?
8.4.2	Type and extent of control
1	Does the organization ensure that the externally provided processes, product and services do not adversely affect its ability to consistently deliver conforming products and services to the customers?
2	Does the organization ensure that the externally provided process remains within the control of its QMS?
3	Has the organization defined the controls to be applied to an external provider and its resulting outputs?
4	Has the organization taken into consideration the potential impact of the organization’s ability to consistently meet customer and applicable statutory and regulatory requirement?
5	Has the organization taken into consideration the effectiveness of the controls applied by the external providers?
6	Has the organization determined the verification or other activities, necessary to ensure that the externally provided processes, products and services meet requirements?
8.4.2.1
1	How does the organization assess external provider performance at planned intervals, and adjust the type and extent of controls to manage associated risks and opportunities?
2	Has the organization maintained documented Information (procedure ) that defines how the requirements of type and extent of control of externally provided processes, products and services are met?
3	How does the organization addresses the determination of the risks to the achievement of specified requirements and to the realization of improvement opportunities for the products and/or services to conformance to specified requirements?
4	Has the organization retained documented information (records) that demonstrates the effectiveness of verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements?
8.4.3	Information for external providers
1	Does the organization ensure the adequacy of requirements prior to their communication to the external provider?
2	Does the organization communicate to the external providers its requirements for the processes, products and services required?
3	Does the organization communicate to the external providers its requirements for the approval of the product and services; methods, processes and equipment; the release of product and services?
4	Does the organization communicate to the external providers its requirements for competence including any qualification of persons?
5	Does the organization communicate to the external providers its requirements for external provider’s interactions with the organizations?
6	Does the organization communicate to the external providers its requirements for control and monitoring of the external providers’ performance to be applied by the organization?
7	Does the organization communicate to the external providers its requirements for verification or validation activities that the organization or its customer intends to perform at the external providers’ premises?
8.5	Production and Service provision
8.5.1	Control of production and service provision
1	Has the organization implemented production and service provision under controlled conditions?
2	Are there any documented information available that defines the characteristics of the product, services or activities to be performed and the results to be achieved?
3	Are any suitable monitoring and measuring resources available? Are they being used?
4	Are monitoring and measuring activities being performed at appropriate stages?
5	Are competent persons (including qualification) being appointed?
6	Is the infrastructure and environment being used suitable for operation of processes?
7	Has the organization implemented any actions to prevent human error?
8	Has the organization implemented any release, delivery and post-delivery activities?
9	Where resulting output cannot be verified by subsequent monitoring or measurement, has the organization conducted validation and periodic revalidation of the process for production and service provision?
8.5.1.1
1	For the validation and periodic revalidation has the organization considered required equipment, competence of personnel, use of specific methods, including identified operating parameters, identification of acceptance criteria and revalidation.
2	How does the organization maintains documented information that defines the controls used to meet the requirements of Control of production and service provision?
3	How does the organization retain documented information (records) to demonstrate the control effectiveness?
8.5.2	Identification and traceability
1	Has the organization used any suitable means to identify output when it is necessary to ensure the conformity of products and services?
2	Has the status of outputs with respect to monitoring and measuring requirements throughout the production and service provision being identified by the organization?
3	Has the organization controlled the unique identification of the outputs when traceability is a requirement?
4	Has the organization retain the documented information necessary to enable traceability, when traceability is a requirement?
8.5.2.1
1	How does the organization maintains documented information that defines the processes used to meet the requirements of Identification and traceability?
8.5.3	Property belonging to customers or external providers
1	When property belonging to customers or external providers is under the organization’s control or being used by the organization, does the organization exercise adequate care?
2	Does the organization identify, verify, protect and safeguard customers’ or external providers’ property?
3	When the property or the customer or external provider is lost, damaged or otherwise, fount to be unsuitable for use, does the organization report this to the customer or external provider? Does the organization retain documented information on what has occurred?
8.5.3.1
1	How does the organization maintains documented information that defines the processes that are used to meet the requirements of Property belonging to customers or external providers?
8.5.4	Preservation
1	Does the organization preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements?
2	Does the organization maintains documented information (Procedure ) for risk-based preservation?
3	Does the documented information defines the methods used to preserve products, including environment controls , and constituent parts throughout operations, delivery to the intended destination, and/or service delivery, in order to maintain conformity to requirements?
	Does the documented information defines the storage areas designated to prevent damage or deterioration of product and constituent parts, pending use or delivery?
4	Does the documented information defines the type and frequency of assessment, appropriate to the product being assessed, to detect deterioration?
5	Does the documented information defines the identification and traceability marks, transportation, handling, packaging, and protection requirements, as applicable?
	Post-delivery activities
8.5.5
1	Does the organization meet requirements for post-delivery activities associated with the product and services?
2	In determining the extent of post-delivery activities does the organization considers the statutory & regulatory requirements; the potential undesired consequences associated with its product and services; customer requirement & feedback; nature, use and intended lifetime of its product and services?
8.5.6	Control of change
1	Do the organization conduct review and control changes for production or service provision to ensure continuing conformity with requirements? The changes for production or service provision includes a) the organizational structure; b) key or essential personnel; c) critical providers; d) design; e) the management system.
2	How does the organization notify customers where changes impact product and/or services to be delivered to the customer?
3	Does the organization retain documented information describing the results of the review of changes, the person(s) authorizing the change and any necessary actions arising from the review?
4	How does the organization reviews changes resulting from assessments of risks and opportunities and corrective actions?
5	When specified how does the the organization notifies the customer of the effect of changes on residual or new risks?
8.6	Release of products and services
1	Has the organization implemented planned arrangements, at appropriate stages, to verify that the product and service requirements have been met?
2	Does the organization ensure that the release of product and service proceed only after the planned arrangement is satisfactorily completed or approved by the relevant authority and as applicable by the customer?
3	Does the organization retain the documented information on the release of products and services and it includes information relating to the evidence of conformity with the acceptance criteria; traceability of the person authorizing the release?
4	How does the organization maintains documented information that defines the processes that are used to meet the requirements of Release of products and services?
8.7	Control of nonconforming outputs
8.7.1
8.7.1
1	Does the organization ensure that the outputs which do not conform to their requirements are identified and controlled to prevent their unintended use or delivery?
2	Is the action appropriate to the nature of the nonconformity and its effect on the conformity of products and services?
3	Do the organization also consider nonconforming product and services detected after delivery of products, during and after the provision of services?
4	When non-conforming products and services are detected does the organization take correction action and/or segregation, containment, return, or suspension of the provision of product & services and/or informing the customer and/or obtaining authorization for acceptance under concession?
5	How are the Conformity to the requirements shall be verified when nonconforming outputs are corrected?
8.7.1.1
1	How does the organization maintains documented information that defines the processes that are used to meet the requirements of Control of nonconforming outputs?
8.7.2
1	Does the organization retain documented information that describes the nonconformity; describes the actions taken; describes any concession obtained; identifies the authority deciding the action in respect of the nonconformity?
Clause 9	Performance evaluation
9.1	Monitoring, measurement, analysis, and evaluation
9.1.1	General
1	Did the organization plan how to monitor, measure, analyze, and evaluate its QMS?
2	Did the organization plan how to monitor QMS performance and effectiveness?
3	Did the organization figure out what needs to be monitored and select methods?
4	Did the organization determine its QMS monitoring requirements?
5	Does the organization select monitoring methods that can produce valid results?
6	Did the organization establish when monitoring should be done and who should do it?
7	Did the organization plan how to measure QMS performance and effectiveness?
8	Did the organization figure out what needs to be measured and did the organization select methods?
9	Did the organization determine its QMS measurement requirements?
10	Does the organization select measurement methods that can produce valid results?
11	Did the organization establish when measuring should be done and who should do it?
12	Did the organization plan how to analyze QMS performance and effectiveness?
13	Did the organization select analytical methods that are capable of producing valid results?
14	Did the organization decide when monitoring and measurement results are analyzed?
15	Did the organization plan how to evaluate QMS performance and effectiveness?
16	Did the organization select evaluation methods that are capable of producing valid results?
17	Did the organization decide when monitoring and measurement results are evaluated?
18	Do the organization monitor, measure, analyze, and evaluate the organization’s QMS?
19	Does the organization monitor the performance and effectiveness of the organization’s QMS?
20	Do the organization record monitoring results and does the organization retain and control these records?
21	Does the organization measure the performance and effectiveness of the organization’s QMS?
22	Do the organization record measurement results and does the organization retain and control these records?
23	Does the organization analyze the performance and effectiveness of its QMS?
24	Do the organization record analytical results and does the organization retain and control these records?
25	Does the organization evaluate the performance and effectiveness of its QMS?
26	Do the organization record evaluation results and does the organization retain and control these records?
9.1.2	Customer satisfaction
1	Does the organization establish methods that the organization can use to monitor customer perceptions?
2	Does the organization figure out how the organization is going to obtain information about how customers feel about how well it is meeting their needs and expectations?
3	Does the organization figure out how the organization is going to review information about how customers feel about how well it is meeting their needs and expectations?
4	Do the organization monitor how well customer needs and expectations are being fulfilled?
5	Do the organization monitor how the organization’s customers feel about how well the organization is meeting their needs and expectations (do the organization monitor the organization’s customers’ perceptions)?
6	How does the organization maintains documented information that defines the process employed to measure customer satisfaction?
9.1.3	Analysis and evaluation
1	Does the organization analyze its monitoring and measurement results?
2	Does the organization analyze and evaluate appropriate data and information?
3	Does the organization use its analytical results to evaluate performance?
4	Does the organization evaluate the performance of its QMS?
5	Does the organization determine if it needs to improve its performance?
6	Does the organization evaluate the performance of its external providers?
7	Does the organization use its analytical results to evaluate effectiveness?
8	Does the organization evaluate the effectiveness of its QMS?
9	Does the organization determine if it needs to improve its effectiveness?
10	Does the organization evaluate the effectiveness of its planning?
11	Does the organization determine if its plans were effectively implemented?
12	Does the organization evaluate the effectiveness of its actions?
13	Does the organization evaluate the effectiveness of actions taken to address risks?
14	Does the organization evaluate the effectiveness of actions taken to address opportunities?
15	Does the organization use its analytical results to evaluate conformity?
16	Does the organization evaluate the conformity of products and services?
17	Does the organization use its analytical results to evaluate satisfaction?
18	Does the organization evaluate the degree of customer satisfaction?
19	How does the organization maintain documented information that defines the process for the identification, collection and analysis of data to demonstrate the suitability and effectiveness of the quality management system?
20	Does the analysis includes include data generated from monitoring and measurement, internal audits, management reviews, and other relevant sources?
9.2	Internal Audit
9.2.1
1	Does the organization conduct internal audits at planned intervals?
2	Did the organization plan a program that can find out if QMS meets the Organization’s own requirement and ISO 9001:2015 requirements?
3	Did the organization plan a program that can find out if QMS is effectively implemented and maintained?
9.2.2
1	Did the organization plan, establish, implement, and maintain an audit program?
2	Did the audit program include the frequency, methods, responsibilities, planning requirements, and reporting?
3	Does the audit program take into consideration the importance of the process concerned, changes affecting the organization, and the results of previous audits?
4	Did the organization define the audit criteria and scope of each audit?
5	Does the organization ensure that the audit is conducted by the auditors to ensure objectivity and impartiality of the audit process?
6	Does the organization ensure that the results of the audits are reported to relevant management?
7	Does the organization take appropriate correction and corrective action without undue delays?
8	Does the retain documented information as evidence of the implementation of the audit program and the audit results?
9.2.3
1	How does the planned intervals of internal audits takes into consideration the risks and opportunities associated with the process of Operational planning and control and the results of performance evaluation?
9.3	Management review
9.3.1	General
1	Does the Top Management review the organization QMS at planned intervals?
2	Does the review ensure QMS’s continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization?
9.3.2	Management review inputs
1	Does the review take into consideration the status of actions from previous management reviews?
2	Are the changes in external and internal issues relevant to QMS considered?
3	Does the review take into consideration information on the performance and effectiveness of the QMS?
4	Does the review take into consideration customer satisfaction and feedback from relevant interested parties?
5	Does the review take into consideration the extent to which the quality objectives have been met?
6	Does the review take into consideration the process performance and conformity of products and services?
7	Does the review take into consideration nonconformities and corrective actions?
8	Does the review take into consideration monitoring and measuring results?
9	Does the review take into consideration audit results?
10	Does the review take into consideration the performance of external providers?
11	Does the review take into consideration the adequacy of resources?
12	Does the review take into consideration the effectiveness of actions taken to address risks and opportunities?
13	Does the review take into consideration the opportunities for improvement?
9.3.3	Management review outputs
1	Do the outputs of the Management review include decisions and actions related to the opportunities for improvement; any need for changes to the QMS; and resources needed?
2	Does the organization retain documented information as evidence of the result of the management review?
Clause 10	Improvement
10.1	General
1	Has the organization determine and select opportunities for improvement?
2	Has the organization implemented any necessary action to meet customer requirements and enhance satisfaction?
3	Has the organization taken action for improving products & services to meet requirements as well as to address future needs and expectations?
4	Has the organization taken action for correcting, preventing, or reducing undesired effects?
5	Has the organization taken action for improving the performance and effectiveness of the QMS?
10.2	Nonconformity and corrective action
1	When any nonconformity (including complaints) occurs, does the organization take action to control and correct it and deal with the consequences?
2	When any nonconformity (including complaints) occurs, does the organization evaluate the need for action to eliminate the causes of the nonconformity?
3	Does the organization reviews and analyzes the nonconformity?
4	Does the organization determine the causes of the nonconformity?
5	Does the organization determine similar nonconformity exist or could potentially occur?
6	Has the organization implemented any action needed?
7	Has the organization reviewed the effectiveness of the corrective action taken?
8	Has the organization updated risk and opportunities determined during planning if necessary?
9	Has the organization made changes to the QMS if necessary?
10	Are the corrective actions appropriate to the effects of the nonconformities encountered?
10.2.2
1	Does the organization retain documented information on the nature of the nonconformities and any subsequent actions taken; and the result of any corrective action?
2	How does the organization maintains documented information that defines the processes that are used to meet the requirements of Nonconformity and corrective action?
10.3	Continual improvement
1	Does the organization continually improve the suitability, adequacy, and effectiveness of the QMS?
2	Does the organization consider the results of analysis and evaluation, and output from management review to determine if there are needs or opportunities to be addressed as part of continual improvement?
10.3.1
1	Does the implementation of improvements shall be subject to management of change processes in accordance with planning of change?
2	How does the organization maintains documented information that defines the processes that are used to meet the requirements of Continual improvement?
3	Does the organization retains documented information to demonstrate its effectiveness?

Example of Quality Manual based on API Q1

0. Introduction

0.1 The Company

// Include your company profile

0.2 Products & Services

// Include your company’s product and services

1.0 Scope

Scope of the Quality Management System of XXX is:

“ Include the scope of your company

Application & Exclusion

In accordance with API Spec Q1, Section 1, XXX has identified the following products from design and development based on API advisory 6 since the exclusion cannot “affect the organization’s ability, or responsibility, to provide products and related servicing that meets customer and applicable regulatory requirements”; and, by API Spec Q1, Section 4.4.1 b), item 1, the justification for the design and development exclusion has been documented within our quality manual and quality management system.

API Spec …………………………………………….
API Spec ……………………………………………
API Spec …………………………………………..

2.0 Normative References

1. API Spec Q1, 9th Edition Specification for Quality Management System Requirement for manufacturing organization for the Petroleum and Natural Gas Industry

2. API Spec …. …………………………………………………………

3. API Spec …. ……………………………………………………………

4. API Spec … ……………………………………………………………

3.0 Terms & Definitions for API Q1

3.1 Abbreviations

XXX: Company name

GM: General Manager

QM: Quality Manual

QMS: Quality Management System

SAS: Systems & Automated Solutions (Divn.)

MR: Management Representative

WI: Work Instructions

Amend: Amendment

BOS: Business Operating System

CAPA: Corrective and Preventive Action

IQA: Internal Quality Audit

MRM: Management Review Meeting / Minutes

NC: Nonconformity

PO: Purchase Order

QA / QC: Quality Assurance / Quality Control

QMSM: Quality Management System Manual

RM: Raw Material

Sec: Section

TS: Technical Specification

OPE: Operator

API: American Petroleum Institute

CFT: Cross-Functional Team

ISO: International Organization for Standardization

QMS: Quality Management System

WI: Work Instruction

QMSP: Quality Management Procedure

D&D: Design & Development

DAC: Design Acceptance Criteria

ITP: Inspection Test Plan

KPI: Key Performance Indicator

MAC: Manufacturing Acceptance Criteria

MOC: Management of Change

MPS: Manufacturing Process Specification

PCP: Process Control Plan

QAP: Quality Activity Plan

QP: Quality Plan

QMS: Quality Management Systems

3.2 Definitions

1 Acceptance criteria

Specified limits of acceptability applied to process or product characteristics.

2 Acceptance inspections

Demonstration through monitoring or measurement that the product conforms to specified requirements.

3 Calibrations

Comparison to a standard of known accuracy and making any needed adjustment(s).

4 Collections

Process of obtaining, assembling, and/or organizing applicable information with the intent of meeting the requirements

5 Compliance

Act or process of satisfying the legal and other applicable requirements of a regulation or regulatory body

6 Critical

The XXX, product specification deem that, or customer as mandatory, indispensable or essential, needed for a stated purpose or task, and requiring specific action.

7 Delivery

Point in time and physical location at which the agreed transfer of ownership takes place

8 Design acceptance criteria (DAC)

Defined limits placed on characteristics of materials, products, or services established by XXX, customer, and/or applicable specifications to achieve conformity to the product design.

9 Design validations

Process of proving a design by testing to demonstrate conformity of the product to design requirements

10 Design verification

Process of examining the result of design and development output to determine conformity with specified requirements

11 First article

A representative sample of a product, component, or output from a process is used to verify that prescribed activities have satisfied the requirements as specified by XXX.

12 Key performance indicator (KPI)

Quantifiable measure that XXX uses to gauge or compare performance

13 Legal requirements

Obligations imposed on XXX, including those that are statutory or regulatory.

14 Management

Person or group of people, as defined by XXX, who directs and controls all or part of a facility, location, department, or other function; has the fiscal responsibility for XXX, and is accountable for ensuring compliance with legal and other applicable requirements.

15 manufacturing acceptance criteria (MAC)

Defined limits placed on characteristics of materials, products, and services established by the XXX to achieve conformity to the manufacture or service requirements.

16 Outsource

Function or process that is performed by an external supplier on behalf of XXX.

17 Preventive maintenance

Planned action to minimize the likelihood of equipment failure and unscheduled interruptions

18 Procedure

Organization’s documented method for performing an activity under controlled conditions to achieve conformity to specified requirements.

19 Risks

Situation or circumstance that has both a likelihood of occurring and a potentially negative consequence

20 Service

Performance of an activity by one function or XXX for another

21 Servicing

Product maintenance, adjustment, repair, and/or on-site installation when applicable product specifications require installation

4.0 QUALITY MANAGEMENT SYSTEM – REQUIREMENTS

4.1 Quality Management System

4.1.1 General

XXX Scope of Quality Management System documentation is defined, established and revision of documents, and their distribution, is controlled. New documents and revisions are reviewed and approved before issue and are identified concerning their revision level. Appropriate documents are available at locations where they are used. Obsolete documents are removed from points of use. Documents of external origin are identified and their distribution is controlled. Quality Records are identified and indexed to facilitate their retrieval and are stored in a suitable environment to minimize deterioration. Quality Records are retained for a minimum period of 10 Years as required by the customer/API product specifications.

XXX has established, documented, implemented, and maintained at all times a Quality Management System for all products and services provided for use in the petroleum and natural gas industry. XXX measures the effectiveness and improvement of the Quality Management System by the requirements of API Spec Q1. Processes for XXX with inputs, outputs and sequences are given in Annexure-II & III. Processes include:

………………………………………………………………………………………………………………….
………………………………………………………………………………………………………………….
………………………………………………………………………………………………………………….
………………………………………………………………………………………………………………….
etc……

Outsourced processes: The calibration of the equipment is outsourced to an external calibration agency. Transportation/delivery of products is often outsourced if necessary. The performance of the outsourced agencies is monitored and controlled. The management provides necessary resources for the processes through HR and their responsibilities & authorities are defined and documented. Risks and opportunities for each process are determined and necessary actions are planned to enhance desirable effects and eliminate/reduce undesired effects. Related Documented Information:

Documented Information	Ref. no
Overall Process Map	Annexure – II
Process Maps : for processes	Annexure – III

4.1.2 Quality Policy

The top management of XXX has established, implemented and maintained a Quality Policy, which is appropriate to the purpose and context of the organization. It provides a commitment to satisfy applicable requirements and continual improvements of the Quality Management system.

The documented Quality Policy is shown in the Annexure.

The Quality policy is communicated, understood and applied within the organization and made available to the relevant interested parties.

Quality Policy to ensure that it is appropriate to XXX is the basis for the development of its Objectives (Refer 4.1.3), and is communicated, understood, implemented, and maintained at all relevant functions and levels within XXX. The policy includes a commitment to the company with requirements and continually improves the effectiveness of the quality management system by specifications API Q1 and ISO 29001:2022.

Authority

Quality policy is established by the top management and is approved by the Chairman. The General Manager must approve any changes to the policy.

Role of the policy

The main role of the Quality policy is to communicate the company’s commitments and aspirations about Quality and to define principal objectives for the Quality Management system.

The policy provides a framework for establishing specific quality objectives and provides direction for the continual improvement effort. The use of policy in setting quality objectives is addressed in this manual

Communication

The Quality policy is posted throughout the company, and its role is explained and discussed at the general orientation training provided to all employees.

The Quality policy is also communicated to customers, consumers and other interested parties. For this purpose, it is displayed in the reception area and posted in the company work area.

Review

The policy is periodically reviewed within the framework of management reviews of the quality system. This is to ensure its continual relevance and suitability. The process for reviewing the policy is defined in the Quality Management System Procedure, Management Review Meetings

XXX policy includes a commitment to comply with requirements and continually improve the effectiveness of the Quality Management System.

4.1.3 Quality Objectives

Quality objectives for all processes are defined and are available to the respective department heads. These are consistent with the quality policy and measurable. Quality Objectives are defined with a focus on achieving product and service conformity and enhancing customer satisfaction. Objectives are monitored and communicated. Documented information on Quality Objectives is maintained. Management, with approval from top management, ensures that Quality Objectives, including those needed to meet product and customer requirements, are established at relevant functions and levels within XXX.

Planning for the achievement of the Objectives is done by covering the action plan, resources responsibility and period. The performance is measured and monitored by the relevant Departments and Management Representatives.

Management Representative in consultation with the Department heads determines fulfilment of the quality objectives periodically and puts forward the results of achievements for Management Review. The relevance and updating of the Quality objective itself is carried out once a year and where a change is required they are suitably done by MR authorized by the General Manager.

4.1.4 Planning

4.1.4.1 General

Management ensures that:

Criteria and methods needed for the operation and control of all Quality Management System processes are determined, managed, and effective; and
Planning of the Quality Management System is carried out to meet the requirements of this specification.

XXX shall determine and define external and internal issues that are relevant to its purpose and strategic goal(s) and that affect its ability to meet the intended result(s) of the Quality Management System. Organizational contexts related to internal & external issues that are relevant and can affect its ability to achieve the intended results of the QMS are identified and documented by the respective departments with proposed actions. Information about these external and internal issues is regularly monitored and reviewed.

XXX has determined interested parties that are relevant to the QMS such as customers, owners/shareholders, Black Gold personnel, and suppliers/channel partners. The interested parties for XXX include Clients, Principals/Service Providers, Employees, Higher Management, and Government / Regulatory Bodies. The departments identify and take care of the needs and expectations of interested parties. Management of XXX is always committed to fulfilling the needs and expectations of all interested parties. The main needs and expectations of the interested parties are given below.

4.1.4.2 Exclusions

In the development and implementation of this Quality Management System by API Spec Q1, XXX has identified, considered and committed that there is no exclusion of the quality management system requirements of API Q1. However, where applicable design and development of products which fall under the provision of API advisory 6 may be applied but are limited to:
• API Spec 6A: • Tees and Crosses; • Ring Joint Gaskets; • Top Connectors; • Flanged Connectors (except Type 6B); • Threaded Connectors; • Adapter and Spacer Spools; • Bullplugs; and • Valve Removal Plugs

4.1.5 Communication

Mode of internal and external communications is informed to the personnel by Department Heads. It includes what to communicate, whom to communicate and when.

4.1.5.1 Internal

Management ensures that appropriate communication processes are established within the XXX and the effectiveness of the Quality Management System is communicated. XXX has established a process to ensure that:

The importance of meeting customer, legal, and other applicable requirements is communicated at relevant functions within the XXX; and
Results of the analysis of data are communicated at relevant levels and functions within XXX.
Internal memos, e-mail communication, phone calls, meetings, training and toolbox meetings do internal communications in XXX.

4.1.5.2 External

XXX determines and implements a process for communicating with external organizations, including customers, to ensure requirements are understood throughout contract execution and product realization. The communication process addresses:

Execution of inquiries, contracts, or order handling and amendments
Provision of product information, including product nonconformities identified after delivery to the customer.
Feedback and customer complaints,
When required by contract, providing information required by product quality plans and subsequent changes to those plans.

The point of contact for the execution of inquiries, contracts, or order handling & and amendments Feedback and customer complaints in XXX is the Commercial officer.

The point of contact for the Provision of product information, including product nonconformities identified after delivery to the customer and when required by contract, providing information required by product quality plans and subsequent changes to those plans is the Machine shop Manager & Quality Systems Manager.

Customer communication

Communication with customers includes

Providing information relating to products and services
Handling inquiries, contracts or orders, including changes
Obtaining customer feedback relating to products and services, including customer complaints
Handling or controlling customer property
Establishing specific requirements for contingency actions, when relevant

Customers are communicated regarding the product information through the letter, verbal, and/ or through phone, Fax, e-mail. If any amendments in inquiries, purchase orders it will be communicated through Phone, letter & Email. The customer complaints are registered in the customer complaint register and the corrective action taken is communicated.

4.2 MANAGEMENT RESPONSIBILITY

4.2.1 General

Management ensures the availability of resources essential to establish, implement, maintain, and improve the Quality Management System. Management provides evidence of its commitment to the development and implementation of the Quality Management System and continually improves its effectiveness by:

Ensuring that Quality Objectives are established including key performance indicators for use in data analysis; and
Conducting Management Reviews.

XXX’s Management has demonstrated leadership and commitment concerning the quality management system through

Taking accountability for the effectiveness of the quality management system by periodical review of the quality management system through management review meetings, Quality objectives review and providing necessary resources.
Management has established the quality policy and quality objectives for the quality management system and is compatible with the context and strategic direction of the organization.
Management has determined the organizational processes and integrated them with the quality management system requirement through process maps & Interaction this can be demonstrated.
The established procedure for promoting the use of the process approach and risk-based thinking.
Ensuring that the resources needed for the quality management system are available, is being periodically reviewed through management review meetings.
Communicating the importance of effective quality management and conforming to the quality management system requirements
Ensuring that the quality management system achieves its intended results
Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system by providing training, conducting awareness programs and
Promoting improvement by introducing the suggestion scheme, Kaizens and conducting meetings.
Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

Customer focus

XXX management has demonstrated leadership and commitment concerning customer focus by ensuring that:

Customer and applicable statutory and regulatory requirements are determined, understood and consistently met.
The risks and opportunities that can affect the conformity of products and services and the ability to enhance customer satisfaction are determined and addressed
The focus on enhancing customer satisfaction is maintained and the procedure for customer satisfaction is addressed

4.2.2 Responsibility and Authority

Responsibilities, authorities, and accountabilities of personnel within the scope of QMS are defined, documented, and communicated throughout XXX. An organizational chart has been established to show the interrelation of personnel in the organization. Job descriptions define the responsibilities and authorities of each of the positions on the organizational chart. Job descriptions and the organizational chart are reviewed and approved by top management for adequacy. These documents are available throughout the organization to help personnel understand responsibilities and authorities.

XXX’s management has ensured that the responsibilities and authorities for relevant roles are assigned communicated and understood within the organization. While assigning roles, responsibility, and authority, top management has considered and ensured that

The quality management system conforms to the requirements of this API Q1 standard.
The processes are delivering their intended outputs
Reporting on the performance of the quality management system and opportunities for improvement, in particular, to top management
The promotion of customer focus throughout the organization
The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

(Refer Organization Chart & Responsibilities, authorities & accountabilities)

4.2.3 Management Representative

Top management appoints and maintains a member of XXX management who, irrespective of other responsibilities, has responsibility and authority that includes:

Ensuring that processes needed for the Quality Management System are established, implemented, and maintained;
Reporting to top management on the performance of the Quality Management System and any need for improvement;
Ensuring initiation of action(s) to minimize the likelihood of the occurrence of nonconformities; and
Ensuring the promotion of awareness of customer requirements throughout XXX.

4.3 ORGANIZATION CAPABILITY

4.3.1 Resources and Knowledge

4.3.1.1 Resources

XXX determines and allocates the resources needed to implement, maintain, and improve the effectiveness of the requirements of the Quality Management System. Resources needed, which include people, infrastructure, environment, monitoring & measuring resources are determined by the respective Department heads and approved by the General Manager. To determine the resources, internal resources’ capabilities and constraints and required competency are considered.

The requirements of personnel and the infrastructure are identified by departmental heads for effective operation and control of QMS and are approved by the General Manager. Personnel could be internal or through external providers. Infrastructure includes:

Systems used for planning & recording (such as ERP) including hardware and software
Processing and testing equipment at the workshop
Information and communication technology

4.3.1.2 Knowledge

XXX determines the knowledge necessary for its operations and to achieve conformity of its products and services. These include:

Product information provided by the external providers / Principals
Information related to repair and servicing (particularly any special processes)
Information on systems and applications installed (such as ERP system, HR system etc.)
Specific product/service related

Product information from training programs/conferences is documented and shared. Service-related information (e.g. discrepancies, customer grievances) is documented and shared. Whenever there a changing requirements, acquiring or accessing additional knowledge or updates are done and documented by the concerned department.

4.3.2 Human Resources

4.3.2.1 Personnel Competence

XXX maintains a documented procedure for defining personnel competency and identifying training requirements or other actions to achieve the necessary competency of personnel whose responsibilities fall within the scope of the Quality Management System. The procedure includes the provision for determining and documenting the effectiveness of the training or other actions taken toward the achievement of required competency.

Management ensures that the personnel performing work which affects conformity to service requirements are competent based on education, training, skills and experience. Where necessary, training is provided to personnel to acquire necessary competence and the effectiveness is evaluated. Personnel competencies are based on the appropriate education, training, skills, and experience needed to meet product and customer requirements. Evidence of the determination of competence of personnel is recorded and maintained. Documented information is maintained as evidence of competence.

4.3.2.3 Training

XXX maintains a documented procedure for training. The procedure includes

Determining the necessary content and frequency of training.
Offering training on the quality management system.
Providing job-specific training, ensuring personnel understand the significance of their roles and how they impact the organization’s quality objectives.
Delivering customer-specific or customer-provided training as needed.
Assessing the efficacy of training.
Documenting essential training records.

XXX

Provides Quality Management System training and job training;
Ensures that customer-specified training and/or customer-provided training, when required, is included in the training program;
Ensures that the frequency and content of training is identified;
Ensures that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the Quality objectives; and
Maintains appropriate records of education, training, skills, and experience
Maintains appropriate records of Personal training

4.3.3 Work Environment

XXX determines, provides, manages, and maintains the work environment needed to achieve conformity applicable to the manufacture of the product. The work environment includes:

Buildings, workspace, and associated utilities;
Process equipment and its maintenance (both hardware and software) ;
Supporting services (e.g. transport, communication, information systems); and
Conditions under which work is performed such as physical, environmental, or other factors.

4.4 DOCUMENTATION REQUIREMENTS

4.4.1 General

Documented information includes manuals, procedures, records, information received or communicated by e-mail etc. Documented information is maintained as required by the quality management system and those determined by the organization for effective operations.

The Quality Management System documentation includes:

Statements of Quality Policy and Quality Objectives;
A Quality Manual that addresses the requirements specified in the standards API Q1
- The scope of the Quality Management System, including the justification for any exclusion to specific Quality Management System elements (Refer to Scope of QMS);
- A description of the sequence and interaction between the processes of the Quality Management System; (Annexure: Sequence and interaction of process)
- Identification of processes that require validation; and
- Reference to documented procedures that control the Quality Management System processes;
- Documented procedures established for the Quality Management System
- Documents and records to ensure the effective planning, operation, and control of its processes and compliance with specified requirements;
- Identification of legal and other applicable requirements to which XXX claims compliance that are needed to achieve product conformity.

4.4.2 Procedures

All procedures referenced within this specification will be established, documented, implemented, and maintained for continued suitability.

Following are ensured while creating & updating documentation.

Identification & description (title, date, reference no)
The format is maintained in the system or as a hard copy.
Reviewed and approved by the authorized person (department head or by MR, as applicable).

4.4.3 Control of Internal Documents

XXX maintains a documented procedure for the identification, distribution, and control of documents required by the Quality Management System and this specification, including required documents of an origin external to XXX. Documented information is controlled so that these are available and suitable for use. Those are protected from improper use, loss of confidentiality, as applicable. For control of documented information, following are ensured:

Distribution to concerned functions.
Ensuring accessibility and retrieval when required.
Ensuring storage and preservation
Version or revision control after changes
Defining retention period and disposition methods.
Ensuring that documents of external origin are identified and their distribution controlled,

The procedure specifies the responsibilities for approval and re-approval and identifies the controls needed to ensure that the documents required by the Quality Management System, including revisions, translations, and updates:

Are reviewed and approved for adequacy prior to issue and use,
Identify changes and revision status,
Remain legible and readily identifiable, and
Are available where the activity is being performed.

Documents of external origin controlled to ensure that the relevant versions are used and maintained. Obsolete documents are removed from all points of issue or use, or otherwise identified to ensure against unintended use if they are retained for any purpose. Procedures, work instructions, and forms required by the Quality Management System are controlled.

4.4.4 Control and Use of External Documents

When API product or other external specification requirements, including addenda, errata, and updates, are used in the design or manufacture of the product, XXX maintains a documented procedure for the integration of these requirements into the product realization process and any other affected process. XXX maintains a documented method for managing externally originated documents needed for product realization and utilized by the organization, such as API or other external specifications. This procedure covers:

Identifying and recording essential documents;
Ensuring access to and distribution of these documents, including the correct versions;
Incorporating these document requirements into product realization and any other relevant processes;
Establishing a procedure to recognize changes to these documents, including addenda, errata, and updates;
Evaluating the effects of these changes; and
Implementing relevant changes into the processes.

Normative references that are identified within API products or other external specifications and are required during product realization are also considered external documents.

4.5 CONTROL OF RECORDS

XXX maintains a documented procedure to identify the controls and responsibilities needed for the identification, collection, legibility, correction, storage, protection from unintended alteration, damage, loss, retrieval, retention time, and disposition of records. Records, including those originating from outsourced activities, are established and controlled to provide evidence of conformity to requirements and XXX Quality Management System. Records remain legible, identifiable, and retrievable. Records are retained for a minimum of ten years or as required by customer, legal, and other applicable requirements, whichever is longer.

5.0 PRODUCT REALIZATION

Planning of the product realization process starts with the review of customer enquiry, contracts, and amendments of contracts if any as described and specified below; This may include but not be limited to product or service requirements as specified by the customer, specification or other statutory or regulatory requirements; development of required process and process documentation; and establishment of product verification and validation programs. The plan also defines the requirement for records necessary to demonstrate process and product conformity.

5.1 CONTRACT REVIEW

5.1.1 General

XXX maintains a documented procedure for Contract Review to review the requirements related to the provision of products and required services. Before committing the products/services, the concerned department reviews that :

The requirements could be met including requirements for delivery and post-delivery activities.
Any statutory and regulatory requirements applicable for the product/services.
Any other requirements to be considered, are not specified by the customer.
Acceptance criteria for the products are defined
Any difference in order requirements from previously expressed ones.

Record is maintained for the results of review of contracts.

5.1.2 Determination of Requirements

XXX determines:

Requirements specified by the customer;
Legal and other applicable requirements; and
Requirements not stated by the customer but considered necessary by XXX for the provision of the product.

Where the customer provides no documented statement of the requirements, the customer requirements are confirmed by the XXX and records are maintained.

5.1.3 Review of Requirements

XXX reviews the requirements related to provision of products. This review conducted prior to XXX commitment to deliver product to the customer and ensures that:

Requirements are identified and documented;
Requirements differing from those previously identified are resolved; and
XXX has the capability to meet the documented requirements.

Where contract requirements are changed, XXX ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements. Records of the results of the review, including resulting actions, are maintained.

5.2 PLANNING

Operational planning is carried out by Individual departments of XXX so that customer requirements are met. The Planning cover:

Requirements of product/services to be provided.
Processes, documents / documented information and resources needed for the product & services
Verification, inspection and measurement activities as applicable.
Acceptance criteria for the products

Delivery schedule is prepared at the quotation stage including service requirements if any. The schedule for delivery and services are monitored to identify and plan the processes and documents needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the Quality Management System (Refer 4.1.4). In planning, XXX addresses the following:

Required resources and work environment management (Refer 4.3);
Product and customer-specified requirements (Refer 5.1);
Legal and other applicable requirements;
Contingencies based on risk assessment (Refer Risk Assessment and Management) and (Refer Contingency Plan);
Design and development requirements (Refer to Design & Development);
Required verification, validation, monitoring, measurement, inspection, and test activities specific to the product and the criteria for product acceptance;
Management of change (MOC) (Refer Management of Change) and
Records needed to provide evidence that the product realization processes meet requirements.

The output of planning is documented and updated as changes occur. The plans are maintained in a structure suitable for XXX method of operations.

Product realization planning

Product realization planning includes, as applicable:

Definition and evaluation of manufacturing operations and process
Development of adequate and capable process
Identification of special process
Consideration of associated risks and consequences
Establishment and implementation of appropriate process control measures
Development of instructions and training for process operators, and
Requirements for records necessary to demonstrate process conformity
Product realization plans are established in collaboration between Marketing, Production, Engineering, and Quality Assurance. The plans are defined in various types of production documents, such as production work orders, operator instructions, etc.,
QMS Procedures related to Control of Production and Operations; explain how outputs of product realization planning are used.

Product verification and validation planning

Product verification and validation plans determine the inspection and testing program for a product, and for materials that are incorporated into the product. This includes:

Identification of inspection and testing points
Inspection and testing scope, frequency, and method
Acceptance criteria, and
Requirements for records necessary to demonstrate product conformity

5.3 RISK MANAGEMENT

5.3.1 General

All Department heads have identified risks for individual processes and controls are developed for all the identified risks. The risks and the issues are addressed with a view to

enhance desirable effects
reduce or prevent undesired effects
achieve improvements

The control actions are implemented considering the potential impact on the conformity of products and services. Actions taken to address the risks and issues are regularly monitored by MR & Department Heads for strict implementation. The department heads maintain the risks, issues and controls thereof as Documented Information. Opportunities for achieving desired improvements are identified by the Department heads and implemented to the extent possible. The results of such implementations are reviewed and achieved improvements are assessed. XXX maintains a documented procedure (Risk Assessment and Management) to identify and control risks associated with impact on the delivery and quality of the product. The procedure identifies the techniques, tools and their application for risk identification, assessment, and mitigation.

5.3.2 Risk Assessment

5.3.2.1 Product Delivery

Risk assessment associated with product delivery includes:

Facility/equipment availability and maintenance; and
Supplier performance and material availability/supply.

5.3.2.2 Product Quality

Risk assessment associated with product quality includes, as applicable:

Delivery of nonconforming products;
Availability of competent personnel.

Records of risk assessment and management including actions taken and maintained

5.3.2.3 Changes Impacting Product Quality

Should any of the below alterations adversely affect the product’s quality, a risk assessment concerning product quality will be conducted by XXX:
a) modifications to the XXX’s structure;
b) shifts in crucial staff members;
c) changes in the supply chain for essential products, components, or processes;
d) adjustments to the scope or methods of the management system;
e) modifications affecting the organization’s ability to execute necessary processes for product realization.
These changes may stem from internal or external sources.

5.3.3 Contingency Planning

XXX maintains a documented procedure for Contingency Planning and needs to address Risks associated with the impact on the delivery and quality of the product. Contingency planning is based on assessed risks, and output is documented, communicated to the relevant personnel, and updated as required. The contingency plan includes, at a minimum:

Necessary actions in response to significant risk scenarios to mitigate effects of disruptive incidents;
Identification and assignment of responsibilities and authorities; and
Internal and external communication controls.

5.3.4 Records

Records of risk assessment and management including actions taken are maintained

5.4 DESIGN

5.4.1 General

As XXX is responsible for the design of products, the requirements of 5.4 shall apply.

5.4.1 Design Planning

XXX maintains a documented procedure (Procedure for Design to Plan) and controls the design and development of the product. The procedure identifies:

The plan(s), including plan updates, used for design.
The design stages;
The resources, responsibilities, authorities, and their interfaces;
The review, verification, and validation activities necessary to complete each design stage;
The requirements for a final review of the design.

When design activities are performed at different locations within XXX, the procedures identify the controls required to ensure that the requirements of designs are met. When design and development are outsourced, XXX ensures the supplier meets the requirements of Outsources given in 5.5.1.7.

5.4.3 Design Inputs

Inputs are identified and reviewed for adequacy, completeness, and lack of conflict. Inputs include functional and technical requirements, and the following, as applicable:

Customer-specified requirements;
Requirements provided from external sources, including API product specifications;
Environmental and operational conditions;
Methodology, assumptions, and formulae documentation;
Historical performance and other information derived from previous similar designs;
Legal requirements; and
Results from risk assessments (Risk Assessment and Management).

Records of design inputs are maintained.

5.4.4 Design Outputs

Outputs are documented to allow verification against the design input requirements.

Outputs:

Meet the input requirements for design;
Provide appropriate information for purchasing, production, and service;
Identify or reference design acceptance criteria (DAC);
Include identification of, or reference to, products, components and /or activities deemed critical to the design;
Include results of applicable calculations; and
Specify the characteristics of the product that are essential for its safe and proper use.

Records of design outputs are maintained.

5.4.5 Design Review

At suitable stages, review performed:

To evaluate the suitability, adequacy, and effectiveness of the results of design stages to meet specified requirements; and
To identify any problems and propose necessary actions.

Participants in such reviews include representatives of functions concerned with the design stages being reviewed. Records of the results of the reviews and any necessary actions are maintained.

5.4.6 Design Verification and Final Review

To ensure that the design, and outputs have met the design input requirements, design and development verification and a final review are conducted and documented by planned arrangements Records of design verification and the final review are maintained.

5.4.6 Design Validation and Approval

Design validation is performed by planned arrangements to ensure that the resulting product is capable of meeting the specified requirements. Validation is completed before the delivery of the product, when possible. The completed design is approved after validation. Competent individuals other than the person or persons, who developed the design, approve the final design. Records of the design validation, approval, and any necessary actions are maintained

5.4.7 Design Changes

Design changes are identified. The changes are reviewed, verified, and validated, as appropriate, and approved before implementation. The review of design changes includes an evaluation of the effect of the changes on the product and/or their constituent parts already delivered. Design changes, including changes to design documents, require the same controls as the original design and development. Records of design changes, reviews of those changes, and any necessary actions are maintained.

5.5 PURCHASING

5.5.1 Purchasing Control

5.5.1.1 Procedure

Products and services provided by external providers are directly delivered to the customers on behalf of XXX. The external providers of products and services for XXX are client / consultant-approved suppliers, with whom agency agreements are made. External providers for IT services are selected by the IT department based on credentials and experience.

XXX maintains a documented procedure (Refer to Control of Externally provided products/Services) to ensure that purchased products, components or activities conform to specified requirements. The procedure address:

Identification of critical products, components or activities;
Initial evaluation and selection of suppliers based on their ability to supply products, components or activities by the XXX requirements;
Type and extent of control applied to the supply chain for critical products, components or activities;
Criteria, scope, frequency, and methods for reassessment of suppliers;
Maintaining a list of approved suppliers and scope of approval; and
Type and extent of control to be applied to outsourced activities.

5.5.1.2 Initial Supplier Evaluation – Critical Purchases

For the purchase of critical products, components or activities, the initial evaluations of suppliers by XXX are site-specific for each supplier and include the following:

Verification that the supplier’s Quality Management System conforms to the quality system requirements specified for suppliers by XXX; and
Verification of the type and extent of control applied by the supplier, internally and to their supply chain, to meet XXX requirements; and
Assessment of the supplier to ensure its capability to meet the XXX specified requirements by one or more of the following:
- Performing an on-site evaluation of relevant activities, or
- Performing first article inspection to ensure conformance to stated requirements, or
- Identifying how the supplied product, component or activity conforms to stated requirements when limited by proprietary, legal, and/or contractual arrangements.

5.5.1.3 Initial Supplier Evaluation – Critical Purchases – Customer Specified, Proprietary, and/or Legal Limited

For the purchase of critical products, components, or activities where the supplier is specified by the customer or involves proprietary and/or legal requirements that limit the application of 5.5.1.2, the initial evaluation of XXX includes the verification of the supplier’s quality management system implementation and conformity to quality system requirements specified for suppliers by the organization and/or the customer’s requirements; and identifying how the supplied product, component or activity conforms to specified requirements.

5.5.1.4 Initial Supplier Evaluation – Noncritical Purchases

For the purchase of noncritical products, components, or activities that impact product realization or the final product, the criteria for evaluation of suppliers by XXX meet the requirements of Refer 5.5.1.2 or satisfy one or more of the following:

Verification that the supplier’s Quality Management System conforms to the Quality system requirements specified for suppliers by the XXX; or
Assessment of the supplier to meet the XXX purchasing requirements; or
Assessment of the product or component upon delivery, or activity upon completion.

5.5.1.5 Supplier Re-evaluation

XXX determines the supplier re-evaluation frequency based on supplier risk and supplier quality performance. For the re-evaluation of suppliers of critical products, components or activities, the requirements of Refer 5.5.1.2 apply. For the re-evaluation of suppliers of non-critical products, components or activities, the requirements of Refer 5.6.1.4 apply.

5.5.1.6 Records

Records of the results of all evaluations including objective evidence and any necessary actions arising from the evaluations will be maintained. Records of identification of approved suppliers, customer-specified suppliers, and suppliers limited by proprietary, and/or legal requirements will be maintained

5.5.1.7 Outsourcing

Where XXX chooses to outsource any activity within the scope of its Quality Management System, XXX ensures that all applicable elements of its Quality Management System are satisfied and maintains the responsibility for product conformance to specified requirements, including applicable API product specifications, associated with product realization. For the workshop, the calibration of equipment is outsourced to an external calibration agency. Transportation/delivery of products is often outsourced if necessary. The performance of the outsourced agencies is monitored and controlled. Records of outsourced activities are maintained.

5.5.2 Purchasing Information

After confirmation of orders by the customer, specifications of products, quantity, terms & conditions, etc. are communicated to the external providers in the Purchase Order. It includes prior approved products/services. Requirements of competence and qualification of personnel as appropriate ( in case of post-delivery installations, maintenance etc. )are specified when services are needed to be provided.

XXX ensures the adequacy of specified purchasing information before their communication with the supplier. Purchasing information provided to the supplier documented and adequately described the product or activity to be purchased, including acceptance criteria, and where appropriate:

Requirements for approval of supplier’s procedures, process, and equipment;
Applicable version of specifications, drawings, process requirements, inspection instructions, traceability, and other relevant technical data;
Requirements for qualification of supplier’s personnel; and
Quality Management System Requirements.

5.5.3 Verification of Purchased Products, Components or Activities

5.5.3.1 General

Controls are applied at their selection and post-delivery performance (output) stages as follows:

External Providers are selected based on their credentials, capability to meet the requirements of the concerned products/services and their record of supply.
The performance of external providers is monitored based on the quality of the products & services supplied and delivery commitments. Records of their evaluations are maintained.
Verification/inspection of products & services is done to ensure that products/services meet the requirements.

XXX maintains a documented procedure (Refer Verification of Purchased Products and Activities) for the verification or other activities necessary for ensuring that purchased products, components or activities meet specified purchase requirements.

5.5.3.2 Critical Purchases

For critical products, components or activities, the procedure addresses the following:

Review of XXX required documentation from the supplier; and
Verification that the applicable versions were used when specifications, drawings, process requirements, inspection instructions, traceability, and other relevant technical data are specified.

Additionally, for critical products and components, the procedure includes requirements for the testing or inspection methods, frequency and responsible party for these activities. The requirements are based on risk associated with supplier product quality. Where XXX or its customer intends to perform verification at the supplier‘s premises, XXX states the intended verification arrangements and method of product release in the purchasing information. XXX ensures and provides evidence that purchased products and activities conform to specified requirements.

5.5.3.3 Noncritical Purchases

All Noncritical products, components or activities are verified as per the XXX’s documented procedure.

5.5.3.4 Records

XXX maintains records of verification activities and evidence of conformity to specified requirements.

5.6 Control of Product Realization

5.6.1 General

The activities of XXX are carried out under controlled conditions. Controlled conditions include:

Availability of documented information describing product characteristics and services to be provided and the results to be achieved.
Availability and use of suitable monitoring and measuring resources.
Implementation of monitoring and measurement activities at appropriate stages to verify outputs and that the acceptance criteria are met.
Engaging competent persons, with requisite qualification and experience for servicing & inspection activities.
Implementation of release, delivery and post delivery activities.
Validation to achieve planned results where the resulting outputs cannot be verified by monitoring and measurement. Such process may include
supply of alignment systems and monitoring systems whose functions can be validated over a period of their functioning.
Special processes such as painting / coating required in servicing.

Concerned engineer obtains feedback from customer for validation.

Production

XXX maintains a documented procedure that describes controls associated with the production of products. The procedures address the following:

The availability of information that describes the characteristics of the product;
Implementation of the product quality plan, when applicable;
Ensuring design requirements and related changes are satisfied, when applicable;
The availability and use of suitable production, testing, monitoring, and measurement equipment;
The availability of work instructions, when applicable;
Process control documents;
Implementation of monitoring and measurement activities; and
Implementation of product releases, including applicable delivery and post-delivery activities.

Servicing

XXX maintains a documented procedure (Control of Servicing) that describes controls associated with the Servicing of products. The procedures address the following:

Review and implementation of the XXX customer-specific, product servicing, and other servicing requirements;
The availability and use of suitable Servicing, testing, monitoring, and measurement equipment;
The availability of work instructions, when applicable;
Ensuring identification and traceability requirements are maintained throughout the Service process;
The implementation of monitoring and measurement activities;
Process control documents ; and
Requirements for release of the product that was serviced.

5.6.2 Quality Plan

When required by contract, XXX develops a quality plan that specifies the processes of the Quality Management System (including the product realization processes) and the resources to be applied to a product. The Quality Plan required by contract are address each of the following as a minimum:

Description of the product to be manufactured;
Required processes and documentation, including required inspections, tests, and records, for conformance with requirements;
Identification and reference to control of outsourced activities;
Identification of each procedure, specification, or other document referenced or used in each activity; and
Identification of the required hold, witness, monitor, and document review points.

These quality plans and any revisions to them are documented and approved by the XXX to ensure customer requirements are met. These Quality Plans and any revisions will be communicated to the customer.

5.6.3 Process Control Documents

Process controls are documented in routings, travellers, checklists, process sheets, or equivalent controls required by XXX and include requirements for verifying conformance with applicable quality plans, API product specifications, customer requirements, and/or other applicable product standards/codes. The process control documents includes, reference instructions and acceptance criteria for process, tests, inspections, and required customer’s inspection hold or witness points. XXX maintains documents of process control.

XXX develops and maintains the documentation that includes but is not limited to product realization plans and records of review/verification, validation, monitoring, measurement, inspection, and test activities, including criteria for product acceptance that demonstrates the capability of XXX to satisfy specified product and/or Service requirements.

5.6.4 Validation of Processes

XXX validate processes for production and Servicing where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is in use or the Service has been delivered. (Validation of Process for Production and Service) Validation demonstrates the ability of these processes to achieve planned results. Where an XXX chooses to outsource a process that requires validation, XXX requires that the supply chain conform to these requirements.

XXX maintains a documented procedure to address methods for review and approval of the process including:

Required equipment;
Qualification of personnel;
Use of specific methods, including identified operating parameters;
Identification of acceptance criteria;
Requirements for records; and
Revalidation.

XXX validates those processes identified by the applicable product specification as requiring validation. If these processes are not identified, or there is no product specification involved, the process requiring validation (if applicable to the product) include, as a minimum;

Non-destructive examination;
Welding;
Heat treating; and
Coating & Plating (when identified as critical to product performance by product specification or by XXX

5.6.5 Identification and Traceability

All material received from external providers are appropriately identified by description and product codes before delivery to customers. For repair /servicing, identification tags are put showing Job number, customer ID. Customer Log is maintained job wise which enables traceability of the products. Where traceability is a requirement, unique identification of the outputs are done and documented information is retained to enable traceability. XXX maintains a documented procedure (Refer Identification and Traceability) for identification and traceability while the product is under control of XXX as required by the XXX, the customer, and/or the applicable product specifications throughout the product realization process, including applicable delivery and post-delivery activities. The procedure includes requirements for maintenance or replacement of identification and/or traceability marks. Records of identification and traceability are maintained.

5.6.6 Inspection/Test Status

XXX maintains a documented procedure (Refer Product Inspection/Test Status) for the identification of product inspection and/or test status throughout the product realization process that indicates the conformity or nonconformity of product with respect to inspections and/or tests performed. XXX ensures that only product that meets requirements or that is authorized under concession is released.

5.6.7 Externally Owned Property

XXX is committed to the protection the External provider and customer while it is under the custody of XXX or in use. Such properties include :

Products supplied by customers for repair/servicing. A Log is maintained for the products.
Customer drawings/sketches, specifications etc. These are kept in safe custody. Soft copies if any are maintained with appropriate access controls.
Manuals provided by equipment suppliers. These are kept in cabinets for reference.
External providers’ supplied products are preserved in stores till delivery. Records maintained on receiving the items and also inspection & delivery records maintained.

In case of any damage or deterioration of customer/external provider’s property takes place, it is immediately informed by the Dept. Head and further actions are taken in consultation with the customer/ external provider. Records of such communication are maintained. XXX maintains a documented procedure (Refer to Customer or External Provider’s Property) for the identification, verification, safeguarding, preservation, maintenance, and control of customer-supplied property, including intellectual property and data, while under the control of the XXX. The procedures include requirements for reporting to the customer any loss, damage, or unsuitability for use of the customer-supplied property. Records for the control and disposition of customer-supplied property maintained.

5.6.8 Preservation of Product

All products are appropriately identified and stored to ensure their conformity. The concerned department head is responsible for appropriate storage conditions. Where necessary, the original Packaging of the products as received, is kept till delivery or consumption. Chemicals (such as paints, and thinners ) & welding consumables are preserved in the workshop as per Material Safety Data Sheet provided by suppliers. All items are kept in a safe place. Where preservation requirement is agreed with the Customer or where found necessary, the same is followed.

XXX maintains a documented procedure (Refer to Preservation of Product) describing the methods used to preserve the product and constituent parts throughout product realization and delivery to the intended destination to maintain conformity to requirements. As applicable, preservation includes identification and traceability marks, transportation, handling, packaging, and protection.

Storage and Assessment

The procedure identifies the requirements for storage and assessment. XXX uses designated storage areas or stock rooms to prevent damage or deterioration of products, pending use or delivery. To detect deterioration, the condition of product or constituent parts in stock is assessed at specified intervals identified by the procedure. The interval is appropriate to the products or constituent parts being assessed. Records of the results of assessments are maintained.

5.6.9 Inspection, Testing, and Verification

5.6.9.1 General

XXX maintains a documented procedure (Refer Inspection and Testing) for inspection and testing to verify that product requirements have been met. The procedures include requirements for in-process inspection, testing, and/or verification methods and their application. It also includes requirements for final inspection, testing, and/or verification methods and their application. Records of required inspection and testing are maintained per documented procedures.

5.6.9.2 In-process Inspection, Testing, and Verification

XXX inspects, tests or varifies the product at planned stages as required by the Quality Plan, process control documents, and documented procedures. Evidence of conformity with the acceptance criteria is maintained.

5.6.9.3 Final Inspection, Testing, and Verification

XXX performs all final inspection and testing or verification by the product Quality Plan and documented procedures to validate and document conformity of the finished product to the specified requirements. Personnel other than those who performed or directly supervised the production of the product perform final acceptance inspection at planned stages of the product realization process.

5.6.9.4 Records

XXX maintains the records of all required inspection, testing, verification, and final acceptance.

5.6.10 Preventive Maintenance

XXX maintains a documented procedure (Preventive Maintenance) for the establishment of preventive maintenance for equipment used in product realization. The procedures identify requirements for:

Type of equipment to be maintained;
Frequency; and
Responsible personnel.

Records of preventive maintenance are maintained.

5.7 Product Release

XXX maintains a documented procedure (Refer Product Release) to ensure release of the product to the customer does not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority (QA/QC Engineer in XXX) and, where applicable, by the customer. Records are maintained to enable identification of the individual releasing the product.

Post-delivery activities

Post-delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services and supplementary services such as recycling or final disposal. Where required in the contract, XXX carries out post-delivery activities which are usually services during the warranty period. Services are carried out by the equipment suppliers except for some batteries and UPS for which services are done by XXX internally. All services are monitored by the concerned dept. and service records are kept with feedback from customers. After servicing / repairs of equipment at the workshop, periodic maintenance or servicing ( in the warranty period) is done if required in the contract. A record of services is maintained.

5.8 Testing, Measuring, Monitoring, and Detection Equipment (TMMDE)

5.8.1 General

XXX determines the testing, detecting, monitoring, and measurement requirements and the associated equipment needed to provide evidence of conformity to those requirements. All TMMDE owned and maintained by XXX, employee-owned equipment, and TMMDE from other sources (e.g. third-party, proprietary, and customer-owned) used to provide evidence of product conformity and monitor process parameters are controlled. TMMDE are to be calibrated at specified intervals. When the specified interval is based on the date of first use, the date of first use is documented.

5.8.2 Procedure

XXX maintains a documented procedure (Refer Control of Testing, Measuring, and Monitoring Equipment) in order to ensure that testing, measurement, and monitoring equipment is calibrated and maintained and that the equipment is used in a manner that is consistent with monitoring and measurement requirements. The procedures include requirements for the specific equipment type that address:

Unique identifier;
Calibration status;
Equipment traceability to international or national measurement standards; where no such standards exist, the basis used for calibration or verification is recorded
Frequency of calibration, at specific intervals or prior to use;
Calibration or verification method, including adjustments and readjustments, as necessary;
Acceptance criteria;
Control of equipment identified as out-of-calibration in order to prevent unintended use; and
When the equipment is found to be out of calibration, an assessment of the validity of previous measurements and actions to be taken on the equipment and product, including maintaining records and evidence of notification to the customer if the suspect product has been shipped.

5.8.3 Equipment

Testing, measuring, and monitoring equipment:

Are calibrated or verified, or both, against measurement standards;
Have the calibration status identifiable by the user for the activities being performed at all times;
Are safeguarded from adjustments that would invalidate the measurement result or the calibration status;
Are protected from damage and deterioration during handling, maintenance, and storage; and
Are used under environmental conditions that are suitable for the calibrations, inspections, measurements, and tests being carried out.

When used in the testing, monitoring, or measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed prior to initial use and reconfirmed as necessary.

5.8.4 TMMDE Equipment from Other Sources

When the equipment is provided from a source external to the XXX, including third-party, proprietary, employee – and customer-owned equipment, XXX verifies that the equipment is suitable and provides evidence of conformity to the requirements of this section. XXX maintains a registry of the required testing, measurement and monitoring equipment used to determine product conformity to requirements that includes a unique identification, specific to each piece of equipment.

5.8.5 Records

XXX maintains a registry of the TMMDE includes a unique identification, specific to each piece of equipment. Records of the results of calibration are maintained. If calibration of the third-party, proprietary, and customer TMMDE is limited by customer, contract, or licensing agreement, the organization shall maintain records of the limitations imposed.

5.9 Control of Nonconforming Product

5.9.1 Procedure

5.9.1.1 General

XXX identifies and controls the nonconforming products and services to prevent their unintended use or delivery. It is applicable also if non-conforming products/services are detected after delivery. XXX maintains a documented procedure (Refer-Control of Nonconforming Products) to identify the controls and related responsibilities and authorities for addressing nonconforming products. Non-conforming outputs are dealt with in one or more of the following ways:

Corrections of the faults identified (of minor nature )
Segregation and re-work of the products/services
Obtaining replacement through the product supplier (for products received).
Obtaining authorization from customers for acceptance

Corrective actions are taken to prevent the recurrence of the non-conformity. After corrections are done, conformity to the requirements is verified. Records are maintained for the non-conformances, showing:

Description of non-conformity
Description of the actions taken
Any concessions obtained.
Authority deciding the corrections & corrective actions.

5.9.1.2 Nonconforming Product During Product Realization

XXX maintains a documented procedure(s) (Refer-Control of Nonconforming Products) to identify the controls and related responsibilities and authorities for addressing nonconforming products. The procedure for addressing nonconforming products identified during product realization includes controls for:

Product identification to prevent unintended use or delivery;
Addressing the detected nonconformity;
Taking action to preclude its original intended use or delivery; and
Authorizing its use, release, or acceptance under concession by the relevant authority and, where applicable, by the customer.

5.9.1.3 Nonconforming Product After Delivery

The procedure for addressing nonconforming products identified after delivery includes controls for:

Identifying, documenting, and reporting non-conformances or product failures identified after delivery;
Ensuring the analysis of product non-conformance or failure, provided the product or documented evidence supporting the nonconformity is available to facilitate the determination of the cause (Refer 6.4.2);
Taking action appropriate to the effects, or potential effects, of the non-conformance when a non-conforming product is detected after delivery.

5.9.2 Nonconforming Product

XXX addresses the nonconforming products by performing one or more of the following:

Repair or rework with subsequent inspection to meet specified requirements;
Re-grade for alternative applications;
Release under concession (Refer 5.10.3); and/or
Reject or scrap.

5.9.3 Release of Nonconforming Product Under Concession

The evaluation and release under concession of the non-conforming product that does not satisfy manufacturing acceptance criteria (MAC) permitted when the XXX relevant authority and the customer (where applicable) have authorized the release provided that:

Products continue to satisfy the applicable DAC and/or customer criteria; or
The violated MAC are categorized as unnecessary to satisfy the applicable DAC and/or customer criteria; or
The DAC are changed and the products satisfy the revised DAC and associated MAC requirements.

5.9.4 Customer Notification of Nonconforming Product

XXX notifies customers of products not conforming to DAC or contract requirements, which has been delivered. XXX maintains records of such notifications.

5.9.5 Records

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained are maintained. The Records includes

the description of the nonconformity;
subsequent actions taken, including concessions obtained;
rationale to support the release of the product under concession; and
relevant authority.

5.10 MANAGEMENT OF CHANGE (MOC)

5.10.1 General

Changes in the product/ service requirements if any are reviewed by the concerned department. The Results of the review and any actions needed are recorded and approved by the department head ensuring conformity with the requirements. XXX maintains a process (Refer to Management of Change) for MOC. XXX ensures that the integrity of the Quality Management System is maintained when changes to the Quality Management System are planned and implemented. For MOC, XXX identifies the potential risks (Refer Risk Assessment and Management) associated with the change and any required approvals prior to the introduction of such changes. XXX maintains the records of MOC activities (Refer to Control of Records). The MOC procedure shall address:

description of, and the need for, the change;
availability and allocation of resources (including personnel);
potential risks that may arise from implementing the change;
review, approval, and implementation of the change;
notifications
verification of the completion of MOC activities and impact on the QMS.

5.11.2 MOC Application

XXX uses the MOC process for any of the following that may negatively impact the quality of the product:

Changes in the organizational structure;
Changes in essential personnel;
Changes in suppliers of critical products, components or activities; and/or
Changes to the management system procedures, including changes resulting from corrective and preventive actions.

5.11.3 MOC Notification

XXX notifies relevant personnel, including the customer when required by contract, of the change and residual or new risk due to changes that have either been initiated by XXX or requested by the customer.

6.0 QUALITY MANAGEMENT SYSTEM MONITORING, MEASUREMENT, ANALYSIS AND IMPROVEMENT

6.1 GENERAL

XXX has planned and implemented the monitoring, measurement, analysis and evaluation processes needed:

to demonstrate conformity of the product,
to ensure conformity with the quality management system, and
to continually improve the effectiveness of the quality management systems.

Documented information is maintained for monitoring, measurement, analysis and evaluation, which includes customer satisfaction, meeting the planned time frame for services, complaints, the effectiveness of the actions taken on risks & opportunities, and the performance of external providers. Measurement and analysis are performed at least once a year. XXX plans and implements the monitoring, measurement, analysis, and improvement process needed to ensure conformity of the Quality Management System to the requirements of this specification and to continually improve the effectiveness of the Quality Management System. Quality Management System Monitoring, Measurement, Analysis, and Improvement include the determination of applicable methods, including techniques for the analysis of data, and the extent of their use.

Process Evaluation

XXX applies suitable evaluation methods to demonstrate the ability of the Quality Management System processes to achieve planned results, including conformity to product requirements. When planned results are not achieved, correction and corrective actions are taken, as appropriate.

6.2 MONITORING, MEASURING, AND IMPROVING

6.2.1 Customer Satisfaction

As one of the performance of quality management systems, the Organization monitors information relating to customer perception as to whether the Organization has met customer requirements. XXX is performing regular customer surveys by using a customer feedback form. Customer feedbacks are reviewed by GM and analysis of customer feedback is presented and discussed during management reviews where the needful corrective and preventive actions can be initiated. Where feedbacks are not received such as from ministries and oil sectors, customer perception is evaluated based on performance such as timely delivery and complaints if any. Customer complaints are considered very vital for improving XXX’s performance. They are recorded and handled as per the documented mechanism of Corrective and Preventive Procedure. XXX maintains a documented procedure (Refer-Customer Satisfaction) to measure customer satisfaction. The procedure addresses the frequency of measurement, obtaining customer feedback, key performance indicators (KPIs), and other information that XXX uses to determine whether XXX has satisfied customers in meeting identified requirements. Records of the results of customer satisfaction information are maintained.

6.2.2 Internal Audit

6.2.2.1 General

The organization conducts internal audits at planned intervals to determine whether the quality management system conforms to the planned arrangements, to the requirements of ISO 9001 and to the quality management system requirements established by the Organization, and that it is effectively implemented and maintained. An audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency, and methods are defined through documented procedures and relevant records. Selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process. Auditors do not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and retaining documented information are defined in a documented procedure. The management responsible for the area being audited ensures that corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of actions taken and the reporting of verification results. Documented information is retained by the Management Representative as evidence of the implementation of audit programs and audit results. Results of internal audits are reported to the higher management in review meetings. XXX maintains a documented procedure (Refer to internal Audit) to define responsibilities for planning, conducting, and documenting internal audits. Audits verify that the Quality Management System is effectively implemented and maintained and conforms to the requirements of this specification. The planning of internal audits takes into consideration the results of previous audits and the criticality of the process being audited. XXX identifies the audit criteria, scope, frequency, and methods to ensure that all processes of the Quality Management System claiming conformity to the requirements of this specification are audited at least every 12 months. Outsourced activities that impact the quality of the product and that are performed at the XXX facility are included as part of the internal audit of the XXX.

6.2.2.2 Performance of Internal Audit

Audits performed by competent personnel independent of those who performed or directly supervised the activity being audited to ensure objectivity and impartiality of the audit process. Records of the audits provide objective evidence that the Quality Management System is implemented and maintained. All processes of the Quality Management System required to meet this specification are audited before claiming conformance to the requirements of this specification.

6.2.2.3 Audit Review and Closure

XXX identifies response times for addressing detected nonconformities. The management responsible for the area being audited ensures that any necessary corrections and corrective actions follow the requirements of corrective action. The results of internal audits and the status of corrective actions are reported in the management review. Records of internal audits are maintained.

6.3 Analysis of data

Individual department heads analyse and evaluate data and information generated from customer feedback, complaints, service reports, and supplier evaluation records, achievement of quality objectives, risks & opportunities. Needs for improvements are identified based on the analysis and evaluation. XXX maintains a documented procedure (Refer Analysis of Data) for the identification, collection, and analysis of data to demonstrate the suitability and effectiveness of the Quality Management System. The analysis includes data generated from monitoring and measurement, internal audits, management reviews, and other relevant sources.

The data analysis output provides information relating to:

Customer satisfaction;
Conformity to product requirements;
Nonconformities and product failures identified after delivery or use, provided the product or documented evidence is available to facilitate the determination of the cause;
Characteristics and trends of processes and products including opportunities for preventive action;
Supplier Performance; and
Quality Objectives.

XXX uses data to evaluate where continual improvement of the effectiveness of the Quality Management System can be made.

6.4 IMPROVEMENT

6.4.1 General

Management of XXX determines opportunities for improvements and implements necessary actions thereof. These include:

Improvement in the products & services for meeting the requirements effectively and also considering future needs and expectations.
Implementing corrective actions and preventive measures to eliminate or reduce undesired effects.
Improving performance and effectiveness of quality management system.

XXX continually improves the effectiveness of the Quality Management System through the use of the Quality Policy, Quality Objectives, Audit Results, Analysis of Data, Corrective and Preventive Actions, and Management Review.

Continual Improvements

XXX continually improves the suitability, adequacy and effectiveness of the quality management system through analysis, evaluation and outputs of Management Review and determines any need for opportunity for continual improvement.

6.4.2 Corrective Actions

XXX takes actions to eliminate the causes of non-conformities including complaints to prevent recurrence. The corrective actions taken are appropriate to the effect of non-conformities encountered and their consequences. XXX maintains a documented procedure (Refer Corrective Action) to correct nonconformities and to take corrective actions, both internally and with suppliers, to eliminate the causes of nonconformities to minimize the likelihood of its recurrence. Corrective actions are appropriate to the effect(s) of the nonconformity encountered. The procedures identify requirements for:

Reviewing a process nonconformity (including customer complaints);
Determining and implementing corrections;
Identifying the root cause of the nonconformity and evaluating the need for corrective actions;
Implementing corrective action to reduce the likelihood that nonconformity recurs;
Identifying the timeframe and responsible person(s) for addressing corrections and corrective action;
Verification of the effectiveness of the corrections and corrective action taken; and
MOC, (Refer 5.11) when the corrective actions require new or changed controls within the Quality Management System.

Records of the activities for control of a nonconforming process are maintained. Records identify the activities performed to verify the effectiveness of the corrective actions taken.

6.5 MANAGEMENT REVIEW

6.5.1 General

Top management of XXX reviews the Organization’s quality management system annually, to ensure its continuing suitability, adequacy, and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Management Review minutes are generated as documented information and distributed to all concerned for review and necessary actions.

XXX’s Quality Management System is reviewed at least every 12 months by the XXX management to evaluate the continuing suitability, adequacy, and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the Quality Management System, including the Quality Policy and Quality Objectives (Refer to Management Review).

6.5.2 Input Requirements

The input to Management Review includes, as a minimum:

Effectiveness of actions resulting from previous management reviews;
Results of audits;
Changes that could affect the Quality Management System, including changes to legal and other applicable requirements (such as industry standards);
Analysis of customer satisfaction, including customer feedback;
Process performance
Results of Risk Assessment (Refer to Risk Assessment and Management)
Status of corrective actions;
Analysis of supplier performance;
Review of the analysis of product conformity, including nonconformities identified after delivery or use (Refer to Control of Nonconforming Products) and
Recommendations for improvement.

6.5.3 Output Requirements

The output from the management review includes a summary assessment of the effectiveness of the Quality Management System. The assessment includes any required changes to the processes and any decisions and actions, required resources, and improvement to products in meeting customer requirements. Top management reviews and approves the output of management reviews. Management reviews are documented and records of these reviews are maintained.

7.0 API MONOGRAM PROGRAM REQUIREMENTS

ANNEX A – API Spec Q1, 10^th EDITION

XXX, an API Licensed organization provides, API monogrammed products, in conformance with API Spec ….., API Spec …., API Spec …., API Spec ….& API Spec …. monogram requirements

A.1 Scope

The API Monogram® is a registered certification mark owned by API and authorized for licensing by the API Board of Directors. Through the API Monogram Program (www.api.org/certification-programs/apimonogram-program-and-apiqr.aspx), API licenses product manufacturers to apply the API Monogram to products that comply with product specifications and have been manufactured under a quality management system that meets the requirements of API Q1. API maintains a complete, searchable list of all Monogram Licensees on the API Composite List website (http://compositelist.api.org).

The application of the API Monogram and license number on products constitutes a representation and warranty by the Licensee to API and to purchasers of the products that, as of the date indicated, the products were manufactured under a quality management system conforming to the requirements of API Q1 and that the product conforms in every detail with the applicable standard(s) or product specification(s). API Monogram Program licenses are issued only after an on-site audit has verified that an organization has implemented and continually maintained a quality management system that meets the requirements of API Q1 and that the resulting products satisfy the requirements of the applicable API product specification(s) and/or standard(s). Although any manufacturer may claim that its products meet API product requirements without monogramming them, only manufacturers with a license from API can apply the API Monogram to their products.

Together with the requirements of the API Monogram license agreement, this annex establishes the requirements for those organizations who wish to voluntarily obtain an API license to provide API monogrammed products that satisfy the requirements of the applicable API product specification(s) and/or standard(s) and API Monogram Program requirements.

For information on becoming an API Monogram Licensee, please contact API, Certification Programs, 1220 L Street, NW, Washington, DC 20005 or call 202-682-8145 or by email at certification@api.org.

A.2 Normative References

API Q1, Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry

A.3 Terms and Definitions

For purposes of this annex, the following terms and definitions apply.

A.3.1 API monogrammable product

Product that has been manufactured by an API Licensee utilizing a fully implemented API Q1 compliant quality management system and that meets all the API-specified requirements of the applicable API product specification(s) and/or standard(s).

A.3.2 API product specification

Prescribed set of rules, conditions, or requirements attributed to a specified product that address the definition of terms; classification of components; delineation of procedures; specified dimensions; manufacturing criteria; material requirements, performance testing, design of activities; and the measurement of quality and quantity with respect to materials; pr XXX takes actions to eliminate the causes of non-conformities including complaints to prevent recurrence. The corrective actions taken are appropriate to the effect of non-conformities encountered and their consequences. products, processes, services, and/or practices.

A.3.3 API-specified requirements

Requirements, including performance and Licensee-specified requirements, outlined in API Q1 and the applicable API product specification(s) and/or standard(s).

NOTE Licensee-specified requirements include those activities necessary to satisfy API-specified requirements.

A.3.4 Design package

Records and documents required to provide evidence that the applicable product has been designed in accordance with API Q1 and the requirements of the applicable product specification(s) and/or standard(s).

A.3.5 Licensee

Organization that has successfully completed the application and audit process and has been issued a license by API

A.4 Quality Management System Requirements

An organization applying the API Monogram to products shall develop, maintain, and operate at all times a quality management system conforming to API Q1.

A.5 Control of the Application and Removal of the API Monogram

XXX shall control the application and removal of the API Monogram in accordance with the following:

Products that do not conform to API-specified requirements shall not bear the API Monogram.
XXX shall develop and maintain an API Monogram marking procedure that documents the marking/monogramming requirements specified by this annex and any applicable API product specification(s) and/or standard(s). The marking procedure (Refer API Monogram marking procedure):
- Defines the authority responsible for application and removal of the API Monogram
- Defines the method(s) used to apply the Monogram
- Identifies the location on the product where the API Monogram is to be applied;
- Requires the application of the Licensee’s license number and date of manufacture of the product in conjunction with the use of the API Monogram;
- Requires that the date of manufacture, at a minimum, be two digits representing the month and two digits representing the year (e.g. 05-12 for May 2022) unless otherwise stipulated in the applicable API product specification(s) or standard(s)
- Requires controls for the application of the additional API product specification(s) and/or standard(s) marking requirements, as applicable.
Only an API Licensee shall apply the API Monogram and its designated license number to API monogrammable products.
The API Monogram license, when issued, is site-specific and subsequently the API Monogram shall only be applied at that site specific licensed facility location.
The API Monogram may be applied at any time appropriate during the production process but shall be removed in accordance with the Licensee’s API Monogram marking procedure if the product is subsequently found to be out of conformance with any of the requirements of the applicable API product specification(s) and/or standard(s) and API Monogram Program.

For certain manufacturing processes or types of products, alternative API Monogram marking procedures may be acceptable. Requirements for alternative API Monogram marking are detailed in the API Policy, API Monogram Program Alternative Marking of Products License Agreement, available on the API Monogram Program website at http://www.api.org/alternative-marking.

A.6 Design Package Requirements

Each Licensee and/or applicant for licensing shall maintain a current design package for all of the applicable products that fall under the scope of each Monogram license. The design package information shall provide objective evidence that the product design meets the requirements of the applicable and most current API product specification(s). The design package(s) shall be made available during API audits of the facility.

In specific instances, the exclusion of design activities is allowed under the Monogram Program, as detailed in Advisory #6, available on API Monogram Program website at http://www.api.org/advisories.

A.7 Manufacturing Capability

The API Monogram Program is designed to identify facilities that have demonstrated the ability to manufacture equipment that conforms to API specifications and/or standards. API may refuse initial licensing or suspend current licensing based on a facility’s level of manufacturing capability. If API determines that additional review is warranted, API may perform additional audits (at the organization’s expense) of any subcontractors to ensure their compliance with the requirements of the applicable API product specification(s) and/or standard(s).

A.8 API Monogram Program: Non-conformance Reporting

API solicits information on products that are found to be nonconforming with API-specified requirements, as well as field failures (or malfunctions), which are judged to be caused by either specification deficiencies or nonconformities with API-specified requirements. Customers are requested to report to API all problems with API monogrammed products. A non-conformance may be reported using the API Non-conformance Reporting System available at http://compositelist.api.org/ncr.asp.

Example of Procedure for management of change

1.0 PURPOSE

The purpose of the procedure is to maintain a process for management of change (MOC). XXX ensure that quality management system is maintained when changes to the quality management system are planned and implemented. The potential risks associated with the change and any required approvals prior to the introduction of such changes are identified and addressed.

2.0 SCOPE

This procedure is applicable to all the following systems and standards

ISO 29001: 2020/ API Spec Q1, 9th edition
API Spec …
API Spec ….
API Spec ….
API Spec …..
API Spec …..

3.0 RESPONSIBILITY

Management Representative
Quality Systems Manager
All concerned process heads

4.0 INPUT:

Management of Change note, Corrective actions report

5.0 RESOURCES

Competent Manpower, Computers, Printer & Internet connection, XXX Procedures

6.0 DESCRIPTION

All members of the XXX, including Company, contractors and vendors are responsible for identification, communication and management of change. The changes that might affect quality of the product:

Changes in the organizational structure,
Changes in key or essential personnel,
Changes in crucial suppliers,
Changes to the management system procedures, including changes resulting from corrective and preventive action

It is important when reviewing a potential change, that each of the above ‘Key Areas’ is considered, as each one could be influenced by, and in turn affect, others. Also, the potential changes should be circulated around the company in an expeditious manner so that a positive and prompt response can be issued to the initiator of the change notice.

7.0 PROCEDURE

The early identification, communication of management of change are the responsibility of all members of XXX. The management of change review process is illustrated Figure 1. Once a potential change is identified, the initiator who can be an individual or department shall inform the MR and raise a management of change request form.

7.1 CHANGES TO PROCESSES

Management system processes will undergo changes, typically when:
- Improvement opportunities have been identified, typically to improve process effectiveness
- Nonconformities within a process are identified and require corrective action
- Conditions in the industry or company change, requiring a process to be updated
- New processes are added which impact on existing processes, requiring changes
- Customer requirements result in a need to change processes
- Any other reason determined by management
In such cases, the process must be changed in a controlled manner to ensure proper authorization and implementation of the changes.
At a minimum, process changes shall include the steps herein:
- The request for a process change shall be documented, in Management of change format XXX/MR/16. The justification for the change shall be recorded.
- The change shall be reviewed by appropriate management, including the senior most manager responsible for the process. Changes must be approved prior to implementation.
- The appropriate process will be updated to reflect the change. This document will undergo review and approval per the procedure of Control of Document
- The follow-up verification step of the CAR process shall seek to ensure the change has had the intended effect, and/or has improved the process. If not, the change may be rolled back or a new change made to correct any new issues that arise as a result of the change.

7.2 CHANGES TO PROCESS OUTPUTS

Where a process output is a document, the rules for changing documents above shall apply.
Formal changes to process outputs will be used when the change is significant. Minor changes may be made without formal control, however the decision on what constitutes a significant vs minor change must be agreed upon by those involved in the change. If a customer indicates a change is significant, this will trump any internal decision.

7.3 CHANGES TO DOCUMENTATION

Management system documents undergo changes when there is a need to revise them.
Changes to documentation are done in accordance with the procedure of Control of Document

7.4 CHANGES TO ORDERS OR CONTRACTS

Changes to active orders or contracts may occur when the customer changes the requirements after the work has begun, or may be initiated by XXX when unforeseen circumstances are encountered.
When changes are initiated by the customer, the new requirements will undergo the same review and acceptance per the procedure for Contract review. If the changes cannot be accepted by XXX a satisfactory solution will be negotiated with the customer.
When changes are initiated by XXX the Machine shop Manager will notify the customer and negotiate a resolution.

7.0 OUTPUT:

Management of change form, training plan, related actions

8.0 KEY PERFORMANCE INDICATOR:

Management of change by taking actions.

9.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTION	FORMAT NUMBER	RESPONSIBILITY
Record of Management of Change	XXX / MR / 16	MR

Example of procedure for Preventive Action

1.0 PURPOSE

The purpose of the procedure is:

To determine and implement preventive actions, both internally and within the supply chain.
To eliminate the causes of non-conformities in-order to minimize the likelihood of its recurrence.

2.0 SCOPE

This procedure is applicable to all the following systems and standards

ISO 29001:2020/ API Spec Q1, 9th edition
API Spec …..
API Spec …..
API Spec …..
API Spec …..
API Spec …..

3.0 RESPONSIBILITY

Management representative
All concerned process owners

4.0 PROCEDURE

The Management determines action to eliminate the causes to potential nonconformities in order to prevent their occurrence.
Preventive Actions are appropriate to the effects of the potential problems.
The preventive action requires the following:
- Identifying the areas of improvement.
- The effective handling of customer complaints and reports of actual non-conformances.
- Reviewing of nonconformities including customer complaints.
- Determining potential nonconformities and their causes.
- Evaluating the need for action to prevent occurrence of nonconformities.
- Determining and implementing action needed.
- Identifying the timeframe and responsible person(s) for implementing a preventive action.
- Preventive actions are implemented to prevent and eliminate non-conformance to a degree, appropriate to the magnitude of problems and commensurate to the risks encountered.
- Records of the results of action taken.
- Reviewing the effectiveness of preventive action taken.
- MOC when the preventive actions require new or changed controls within the Quality Management System.
Preventive actions which are implemented are monitored and audited by the Management Representative & Quality Systems Manager to assess the effectiveness of the action taken.
Records of Preventive Actions taken are maintained and retained for five years.

4.1 Effectiveness Review on Preventive Action:

In XXX, effectiveness of the Preventive action taken is reviewed through a NC closure verification checklist.
Management Representative reviews effectively and may insist for more action, if required. This activity is subject to further evaluation at the time of the Management Review.

4.2 Areas of responsibility:

The management and all employee of the respective location are responsible for introducing preventive action in the company
All employees in departments, which influence product quality are obliged to:
- Identify and eliminate potential non conformities
- Introduce effective preventive measures and show that these are effective

4.3 Source of information:

It is necessary for appropriate sources of information to be checked so that potential cause of discrepancy can be recognised, analysed and eliminated.
Such sources are:
- Quality data from processes
- Data and trends from goods inwards inspection
- Data on scrap material
- Data on rework
- Results of intermediary and final inspection and checking
- Results of system, procedure and process audits
The Management Representative/Quality Systems Managereither carry out these checks himself or organise and assess them
Common problem solving methodologies like QC story, Fish-Bone diagrams are used to solve the problems.
The results of the problem solving methodology are documented appropriately by concerned personnel and these documents are subject to verification during MRM.

5.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTION	FORMAT NUMBER	RESPONSIBILITY
Customer Complaint Record	XXX / QA / 14	QA/QC Engineer
Non conformance Product Report	XXX / QA / 42	QA/QC Engineer
Non conformance Report	XXX / MR / 09	Management Representative
Preventive Action Request	XXX / MR / 17	Management Representative

Example of Procedure for Analysis of Data

1.0 PURPOSE

The purpose of the procedure is to establish a system for the identification, collection, and analysis of data to demonstrate the suitability and effectiveness of the quality management system. At XXX, Data analysis includes data generated from monitoring and measurement, internal audits, management reviews, and other relevant sources.

2.0 SCOPE

This procedure is applicable to all the following systems and standards

ISO 9001: 2020/ API Spec Q1, 9th edition
API Spec ….
API Spec …..
API Spec …..
API Spec …..
API Spec ….

3.0 RESPONSIBILITY

Management Representative
Quality Systems Manager
All concerned process heads

4.0 INPUT

Customer satisfaction Feedback
Customer Complaints
Audit Results
Conformity to product requirements.
Nonconformities and product failures identified after delivery or use.
External provider/Suppliers Performance
Quality objectives

5.0 RESOURCES

Competent Manpower, Computers, Printer & Internet connection, Stationaries, XXX Procedures

6.0 PROCEDURE

Management Representative reviews the data collected like customer complaints and identifies the statistical techniques for establishing, controlling and verifying process capability, product characteristics.
As soon as suitable technique is identified, it is used in the relevant area.
The analysis of data provides information relating to;
- Customer satisfaction
- Customer Complaints
- Self – Assessment
- Audit Results
- Conformity to product requirements.
- Nonconformities and product failures identified after delivery or use, provided the product or documented evidence is available to facilitate the determination of the cause
- Characteristics and trends of process and products including opportunities for preventive action.
- Suppliers Performance
- Information on Quality objectives
Corrective actions taken are to ensure their effectives.
The Data Analysis record is maintained.
The data from the above is analyzed periodically (at least once in 3 months) and statistical report is prepared and submitted to the top management (CHAIRMAN) for information and necessary follow-up for the corrective action and continual improvement of the system/area.
Summary of the statistical analysis is produced in the Management Review Meeting.

6.1 CUSTOMER FEED BACK

Customer Satisfaction is detailed in procedure for Customer Satisfaction

6.2 CUSTOMER COMPLAINT

All customer complaints received within XXX are recorded in the customer complaint Record.
It is the responsibility of all managers and staff to report in case of receipt of any customer complaints to the Quality Systems Manager and Management Representative by forwarding such written complaints received from the client. In case of verbal complaints the concerned personnel records such complaint in the customer complaint Record or send a written note to the Management Representative.
The customer complaint is used as a tool for the verification of customer satisfaction. All customer complaints within XXX are logged in the customer complaint record and are subject to the verification of Management Representative, and a review of customer complaints is carried out periodically.
All personnel in XXX have the responsibility to inform the Management for any customer complaints reported verbally or in written format.
Each customer complaint is treated as Non-conformities within XXX and necessary corrective and preventive actions taken accordingly.
No of customer complaints/ or the frequency of customer complaints are monitored in weekly basis and the trend of NCs are reviewed accordingly.
Management Representative summarizes the above with the status of corrective and preventive action and furnish the same for the Management Review.

6.3 VERIFICATION OF CONFORMITY TO PRODUCT REQUIREMENT

XXX realize that the product conformance are the results of using right personnel on right job, using right material, machinery, tools etc., and well understanding of customer requirements. All personnel performing product manufacturing or providing services are trained to carry out their task in order to meet the product service requirements.
This requirement is being monitored during various stages of the manufacturing process or service by the supervisors and Inspection personnel.
Training needs and records are verified during Management Review Meetings once in 12 months.
All production equipments are checked periodically and monitored for its fitness for the intended use. All measuring equipments are calibrated, validated and checked prior to use. Records are maintained for historical review.
Deviations and non-conformities, trends of NCs, reasons, occurrence and recurrence are recorded and verified periodically, and necessary corrective action and opportunities for preventive measures are verified accordingly.

6.4 SUPPLIER OR SUB-CONTRACTOR VERIFICATION

In order to maintain the product/service quality, XXX has to be aware of the performance of the vendor/supplier/ sub-contractor that can be managed within this Quality Management System.
XXX follows an approved vendor/subcontractor list and the suppliers and sub-contractors are reviewed once in 12 months.
Data pertaining to each supplier or subcontractor are maintained in the Procurement Department.

7.0 OUTPUT

Analysis of Customer feedback, analysis of Supplier performance, Quality objectives status, Analysis of Audit Results, Conformity to product requirements.

8.0 KEY PERFORMANCE INDICATOR

All analysis done and related action plans & corrective actions

9.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTION	FORMAT NUMBER	RESPONSIBILITY
Master List of Quality Objectives	XXX / MR / D07	Management Representative
Nonconformance Report	XXX / MR / 09	Management Representative
QHSE Performance Analysis	XXX / MR / 22	Management Representative
Customer feedback form	XXX / COM / 04	Commercial Officer
Annual Customer Evaluation	XXX / COM / 09	Commercial Officer
Production Monitoring & Delivery Status	XXX / COM / 10	Commercial Officer
Supplier Evaluation Form	XXX / PRO / 04	Procurement Engineer
Vendor Rating	XXX / PRO / 06	Procurement Engineer
Customer Complaint Record	XXX / QA / 14	QA/QC Engineer
Nonconformance Product Report	XXX / QA / 42	QA/QC Engineer