1. SCOPE

This procedure is to ensure any non-conforming situations identified internally / externally that affect the quality of service delivered by the XXX are corrected or appropriate corrective actions are initiated, recorded, reported, implemented & the effectiveness of the action taken is verified.

2. PURPOSE

Management Representative has overall responsibility for the effective implementation of this procedure.  Non-compliance or non-fulfillment of any of the QMS requirements is considered as a non-conformance and management responsible for the process is expected to record such non-conformances using the “Correction / Corrective Action request form” with the approval of the XXX Department Manager.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2 Procedure for Internal QMS Audit

4. TERMS & DEFINITIONS

NC- Non-conformance – Non-fulfilment of a requirement
CA-Corrective Action- Action to eliminate the cause of detected non-conformity
C- Correction- Action to eliminate a detected non-conformity

5. RESPONSIBILITY AND AUTHORITY

Management Representative has overall responsibility for the effective implementation of this procedure. Non-compliance or non-fulfillment of any of the QMS requirements is considered as a non-conformance and management responsible for the process is expected to record such non-conformances using the “Correction / Corrective Action request form” with the approval of the NGT Department Manager.

6. DETAILS OF PROCEDURE

6.1.Possible Input Sources for Corrective Actions 

6.1.1 Non-conformities/non-compliances observed during Sales or operations and any other non-fulfillment of the requirement in the XXX business process during the day-to-day operations.
6.1.2 Complaints & feedback from customers
6.1.3 Internal / external audits
6.1.4 Any corrective action request for observations regarding a deviation found in the XXX Quality management system.

6.2 Issuing a Correction, Corrective Action Request

6.2.1 A process owner who identifies nonconformity or a deficiency in the management system must record it in the corrective action report form (QMS F 023) CORRECTIVE ACTION REPORT shall be used to fill the findings and submit them to the Management Representative.
6.2.2 Whoever originates a request shall ensure appropriate immediate corrections are taken if the observations cause a direct impact on the process of customer satisfaction. No Corrective action request shall be processed unless appropriate corrections are ensured. If no Corrective Action required, the same shall be recorded in the form.
6.2.3 Review / complete the received Correction / Corrective Action request and approve its requirement / adequacy. Definition of the problem / finding reported shall be genuine and worth proceeding with the Corrective Action process.
6.2.4 Allocate a continuous Serial Number affixed with the year for each request and record the same in the Corrective Action Tracking sheet, which will be used for updating the progress of Root cause, Recommended action, Action was taken & effectiveness.
6.2.5 If the problem/finding reported is serious in nature, an investigation shall be initiated with all involved parties to identify what caused the problem and root cause (s) are properly described in the Corrective Action Request with the most appropriate recommended action.
6.2.6 Completed request is submitted to Department Manager for Approval
6.2.7 Verify the action taken is effective by means of auditing, reviewing sample records in the future
6.2.8 Update the Corrective Action Tracking sheet and sign-off the corrective action request raised.
6.2.9 In case of customer complaints received, the customer complaint form shall be used to fill the complaints and attached with the Correction / Corrective Action request form.
7. RETAINED DOCUMENTED INFORMATION

7.1 Non-Conformance Report(QMS F 022)
7.2 Corrective Action Report(QMS F 023)
7.3 Corrective Action Tracker(QMS F 024)
7.4 Customer complaints (QMS F 025)

1. SCOPE

The purpose of this procedure is to define how the company’s Strategic Direction is developed by senior management through the identification of interested parties, issues of concerns, risks, and opportunities.

2. PURPOSE

This procedure applies to all the activities within the scope of the XXX Quality Management System.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,

4. TERMS & DEFINITIONS
IP- Interested Parties
R-Risk
O-Opportunity
SOP- Standard Operating System

5. RESPONSIBILITY AND AUTHORITY

The Management Representative (MR) and HOD’s of all departments are responsible for the effective implementation of this procedure.

6. DETAILS OF PROCEDURE

6.1. Interested Parties

6.1.1 “Interested parties” are those stakeholders who receive our Products or Services Processes., who may be impacted by them, or those parties who may otherwise have a significant interest in our company. The interested parties applicable to XXX are listed in the Risk and Opportunity register, along with the reason for their inclusion. This includes both internal and external parties.
6.1.2 The identification of an interested party does not necessarily bring that party into the scope of the QMS; for example, labor union leadership may be identified as an interested party, but that does not mean QMS documents and policies must be developed related to them.
6.1.3 Properly planning a change by applying risk-based thinking can help to avoid negative consequences such as rework or cancellation or postponement of service; it can also result in positive consequences such as reduction of nonconforming outputs; or reduced incidents of human error

6.2 Issues of Concern

6.2.1 For each interested party, the related issues of concern shall be identified in the Risk Register. These issues may reflect direct concerns of the party (for example, customers are concerned about the quality of products or services they purchase) or they may be indirect concerns. Such concerns may impact the interested party, or maybe concerns derived from the party that impacts the company.
6.2.2 Issues may be either internal or external, depending on whether the interested party is internal or external. In addition, a certain type of party may have both internal and external concerns.
6.2.3 When attempting to identify internal concerns, it may be useful to consider service concerns, employee concerns, etc.
6.2.4 When attempting to identify external concerns, it may be useful to consider concerns arising from competition, society and culture, labor relations, statutory and regulatory issues, supply chain, economic issues, etc.

6.3 Risk and Opportunity

6.3.1 Management will then identify risks and opportunities related to the issues of concern within the Risk and Opportunity register.
6.3.2 Within the Risk register, each risk and opportunity will be noted, along with the primary process involved.
6.3.3 Management will then determine a treatment method for each risk or opportunity. Risks are managed to reduce their likelihood and severity, while opportunities are managed to increase their likelihood and benefits. Blended issues may require more complex treatment.
6.3.4 Where a risk is determined to be treated, these must then be entered into the Risk and Opportunity Register.
6.3.5 Opportunities are managed via the Opportunity in Risk Register

6.4 Strategic Direction

6.4.1 From the information above, the CEO devises a “strategic direction” which is documented in the records of management review.

7. RETAINED DOCUMENTED INFORMATION

7.1 Internal issues(QMS F 015)
7.2 External issues(QMS F 016)
7.3 Pest Analysis (QMS F 017)
7.4 SWOT Analysis (QMS F 018)
7.5 Porter’s 5 Forces (QMS F 019)
7.6 Needs and expectations of Interested Parties (QMS F 020)
7.7 Steps to derive the scope of the organization (QMS F 021)

1. SCOPE

The purpose of this procedure is to define the methods for managing changes to processes and other aspects of the management system in a controlled manner so as to maintain the integrity of the QMS and the organization’s ability to continue to provide conforming products and services during the change.

2. PURPOSE

This procedure applies to all the activities within the scope of the XXX Quality Management System.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,

4. TERMS & DEFINITIONS
CM- Change Management
R-Risk
O-Opportunity
SOP- Standard Operating System

5. RESPONSIBILITY AND AUTHORITY

The Management Representative (MR) and HOD’s of all departments are responsible for the effective implementation of this procedure.

6. DETAILS OF PROCEDURE

6.1. Properly planning a change by applying risk-based thinking can help to avoid negative consequences such as rework or cancellation or postponement of service; it can also result in positive consequences such as reduction of nonconforming outputs; or reduced incidents of human error

6.2 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 existing processes, requiring changes.
• Outsourcing important processes.
• Persons in key roles leaving the organization.
• Customer requirements result in a need to change processes.
• Changes to active orders or contracts.
• Any other reason determined by management.

6.3 In such cases, the process must be changed in a controlled manner to ensure proper authorization and implementation of the changes.
6.4 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 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.
6.5 At a minimum, process changes shall include the steps herein:

• The request for a process change shall be documented, typically in a Change Request. The justification for the change shall be recorded.
• Management shall evaluate the merits of the proposed change and determine the actions necessary to address and implement the intended changes. Wherever it is deemed essential other departments will be consulted about proposed changes. This may include discussions with engineers, contractors, consultants, or other relevant parties before according approval for the proposed change.

6.6 Before authorizing the implementation of changes, the following points shall be verified;

•  All necessary technical, safety, security, and environmental reviews are completed;
•  Risks and consequences identified during the review processes are addressed to the utmost satisfaction;
  Proposed changes comply with regulatory and legal requirements;
• Necessary approvals are obtained from the regulatory and/or legal authority wherever required;
• All affected personnel are informed of the changes and adequately trained where necessary;
• Documentation pertaining to changes and reviews is complete.

6.7 The change shall be reviewed by appropriate management, including the HOD responsible for the process. Changes must be approved prior to implementation. CEO is authorized to approve the implementation of proposed changes.
6.8 Upon implementation of change, MR shall verify the following.

• Implemented changes are as intended;
• Documentations are complete pertaining to changes;
• Changes are communicated
• Applicable regulatory and legal requirements are fulfilled;
• Project Plan and Budget are amended

6.9 All Changes must be logged as per Change Log. (QMS F 014)

7. RETAINED DOCUMENTED INFORMATION

7.1 Change Management Request(QMS F 013)
7.12Change Log(QMS F 014)

1. SCOPE

The purpose of this procedure is to manage the business risks and opportunities that arise from the context of xxx and the requirements of interested parties.

2. PURPOSE

This procedure applies to all the activities within the scope of the XXX Quality Management System.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2  ISO 31000:2018 standard
3.3  Procedure for Context of the organization

4. TERMS & DEFINITIONS
RM- Risk Management
R-Risk
O-Opportunity
SOP- Standard Operating System

5. RESPONSIBILITY AND AUTHORITY

The Management Representative (MR) and HOD’s of all departments are responsible for the effective implementation of this procedure.

6. DETAILS OF PROCEDURE

XXX has documented procedure to identify & control risk associated with impact on delivery & quality of products. This procedure identifies techniques, tools & their application for risk identification, assessment and mitigation.

6.1 RISK ASSESSMENT:

Risk Assessment Associated with Delivery of product shall generally include, but not limited to following:

1. Availability of facilities & their maintenance
2. Availability of equipment
3. Breakdown / preventive maintenance of equipment
4. Material availability
5. Timely Supply of material
6. Quality of supplied material
7. Suppliers performance in terms of Quality, Delivery & Other capabilities
8. In adequate QA / QC activities

Risk assessment Associated with product Quality shall generally include, but not limited to following:

1. Competencies & Performance of critical, non-critical suppliers, sub-contractors, and outsourced vendors
2. Delivery of non-conforming products to customers
3. Maintenance of  Facilities, equipment including testing equipment
4. Incoming, Inprocess, and final inspection and its controls.
5. Addressing the non-conformance of the product in process at all levels to avoid the effect or potential effects on the final product.
6. Availability of competent personnel.

Risk assessment provides a structured process for analyzing risk in terms of consequences and likelihood before deciding on further actions.

Records of risk assessment and management including actions taken are maintained.

This structured process attempts to answer some fundamental questions:

1. What may happen and why (risk identification)?
2. What might be the consequences?
3. What is the likelihood of them happening? And
4. Is there anything that might mitigate the consequences or reduce the likelihood?

Risk identification:

It is defined as the process of finding, recognizing and describing risk. It could be a historical data or theoretical analysis which involves identification of risk sources, events, causes and their potential consequences which delay the origination’s objectives

Risk analysis:

It is the process of analyzing the nature of risk and determining the level of risk associated with the relevant activity. RPN (Risk Priority Number) is used for analyzing the impact. Risk analysis provides an input to risk evaluation and decisions on whether risks need to be treated and on the most appropriate risk treatment strategies and methods. Risk analysis also provides an input into making decisions where choices must be made and the options involve different types and levels of risk. Risk analysis involves consideration of the causes and sources of risk, their positive and negative consequences and the likelihood that those consequences can occur. Factors that affect consequences and likelihood identified. Risk is analyzed by determining consequences and their likelihood, and other attributes of the risk. An event can have multiple consequences and can affect multiple objectives. Existing controls and their effectiveness and efficiency are taken into account. The way in which consequences and likelihood are expressed and the way in which they are combined to determine a level of risk to reflect the type of risk the information available and the purpose for which the risk assessment output is to be used.

The significant risk associated with each process are segregated based on the below 5 categories,

Men:

Human resource is one of the important and mandatory requirements for product realization which includes workmen, staff and managers.

Machine:

A machine is an important resource to meet the required product realization and possible risk like breakdown / out of tolerance is considered while carrying out risk analysis.

Method:

Risk related to material handling and preservation of the product is considered in method.

Material:

Risk related to material rejection, delayed shipment from the supplier, raw material shortage considered for carrying out risk assessment.

Environment:

Risk related to natural disaster and their impact on quality or delivery of the product with required communication is considered.

Risk evaluation:

The purpose of risk evaluation is to assist in making decisions, based on the outcomes of risk analysis, about which risks need control / mitigation and the priority for control / mitigation implementation. Risk evaluation involves comparing the level of risk found during the analysis process with risk criteria established. Based on this comparison, the need for control /mitigation can be considered

Risk control / mitigation involves,

1. Deciding whether residual risk level are tolerable, if the XXX feels that the present non-significant risk become significant in future, then it is treated as significant.
2. If not tolerable, generating a new risk treatment and assessing its effectiveness Further, activities pertaining to the below criteria is called as significant which requires proper action plan.

6.2 GUIDELINES FOR DETERMINING RPN:

The guideline followed at XXX to determine RPN while performing risk assessment includes the following important terms.

Severity evaluation criteria (S):

Severity for the each activity / problem is worked based on the amount of impact it creates on the equipment / legal / customer satisfaction (delivery and product quality). The value range is between1 to 5. The tabulation 01 used to plot the applicable severity number for the relevant activity is given in Guideline 2. When the severity is 5, it is defined as critical class (CC), and for the values 4 it is called significant class (SC) and less than 3 are common activity are left unfilled.

Occurrences evaluation criteria (O):

Occurrence for each activity / problem is worked based on the number of repeated cases in the past history or assumptions based on experience. The value range is between 1 to 5.The tabulation 02 used to plot the applicable occurrences number for the relevant activity is given in Guideline 2.

Detection evaluation criteria (D):

Detection for each activity is defined as the possibility of capturing the problem / defect with the present existing controls. The value ranges from 1 to 5. The tabulation 03 used to plot the applicable detection number for the relevant activity.

Risk assessment output:

The output of risk assessment is used as an input for contingency planning and also the same is considered in corrective and preventive actions

Risk assessment Frequency

The Risk assessment at SOS is carried out once in a year for all the relevant processes and the records are documented with necessary actions. Re-evaluation can be done, whenever there is need due to Management requirement, major process change and customer request, changes in the RPN number and major quality or delivery issue.

TABLE 01 – SEVERITY (S) EVALUATION CRITIERIA

Effect	Criteria: Severity of Effect	Ranking
Catastrophic	Very high severity & multiple effect on product quality or delivery. Severe & wide spread damage to the customer with respect to delivery & quality of product	5
Critical	Major Severity & Multiple  effect on product quality or delivery	4
Serious	Single severe impact & Multiple Minor impact on product quality and delivery	3
Minor	Low or minor impact and short term effect on product quality and delivery	2
Low	Negligible or trivial effect and or impact on product quality and delivery	1

TABLE 02 – OCCURRENCE EVALUATION CRITERIA

Probability	Ranking
Frequent : Persistent Failures (shall occur Several times )	5
Probable :  Frequent Failures (Occurs Repeatedly / an event to be expected )	4
Occasional : Occasional Failures (Could take place or occur sometimes)	3
Remote : Relatively unlikely & Few Failures	2
Improbable : Failure so is unlikely that probability not there	1

TABLE 03 – DETECTION EVALUATION CRITERIA

Detection	Criteria	Suggested Range of Detection Methods	Ranking
Almost Impossible	Absolute certainty of non-detection of problem	Cannot detect or is not checked	5
Low	Control have poor chance of detection of problem	Control is achieved with visual inspection only	4
Moderate	Controls may detect the problem	Control is based on variable gauging after parts have left the station, or Go/No Go gauging performed on 100% of the parts after parts have left the station	3
High	Controls have a good chance to detect the problem	Error detection in station or error detection in subsequent operations by multiple layers of acceptance: supply, select, install, verify. Cannot accept discrepant part	2
Very High	Controls certain to detect the problem	Discrepant parts cannot be made because the process or the equipment / item have been error-proofed by process / product design.	1

Based on above criteria given in Table No. 1, 2 & 3 severity, occurrence and detection rating for each potential risk is determined. While determining this potential causes for failures are taken into account for severity rating, current process control prevention are considered while doing occurrence rating.

Risk Priority Number (RPN):    RPN = S X O X D where S – Severity Rating, O – Occurrence rating and D – Detection Rating. RPN no. for each potential risk is determined. Value of RPN is always from 1 to 125. The RPN value is used to rank the order of concern in the Product delivery and Product Quality.  Special attention is to be given when the value of RPN is 80 or more than 80 or alternatively if Severity value is more than 4. The highest severity of effect should be taken for calculating risk priority number.

In SOS we have set a cut off limit of RPN value as 80. Appropriate corrective actions are recommended & Implemented in all such cases where RPN value exceeds 80. And also risks having RPN number more than 80 are considered for contingency planning and entered in the risk assessment register.

Recommended action and or Mitigation

After completion of the steps described above, the RPNs are to be analyzed to identify the priority areas for control and mitigation.  Higher risk priority numbers generally requires immediate action and contingency planning, however the severity ranking more than 4 are to be considered with high priority irrespective of the RPN value.

The recommended actions are to be taken to prevent / eliminate the causes to reduce the occurrence ranking. The general steps for risk mitigation are:

1. Where Possible risk elimination
2. Substitution by alternate man , material , machine or method as applicable
3. Segregation of products and or  material
4. Changes in the system of working that reduces the risk to an acceptable level ( This includes having written procedure , adequate supervision , training and information & instructions

Verification of implementation:  QA / QC Engineer has to verify the action for implementation. After the corrective action have been implemented estimate & record the resulting ‘Severity’, ‘Occurrence’ and ‘Detection’ rankings. Calculate the “Resulting RPN”. If no actions are taken, leave the related ranking columns blank.

Risk Assessment review & updating: This document is a dynamic document, this is to be reviewed whenever there is a change in process, customer requirement, on identification of new failures & causes, when the process becomes unstable & / or incapable. Whenever Risk Assessment  is reviewed the concerned process related documents like Quality  plan, operating instructions, setup instructions, maintenance instructions etc. are to be reviewed and updated as required.

ISO 9001:2015 – QMS SPECIFIC REQUIREMENTS

GENERAL

• SOS considers and manages risks and opportunities differently.
• Risks are managed with a focus on decreasing their likelihood, and minimizing their impact if they should occur.
• Opportunities are managed to increase their likelihood, and to maximize their benefits if they should occur.
• Where risks and opportunities overlap, the best appropriate method for managing them shall be ascertained, given the situation at hand. Elements of such “blended” uncertainties may require methods which both address the negative risk and positive opportunity.

MANAGEMENT OF RISKS

• Risks are identified as part of the “Context of the Organization Exercise”
• Additional risks are identified department wise by doing brain storming by concerned department heads. Risk also can be identified by any employee of XXX.
• Each process owner identifies the risk/Opportunities associated with different activities in their department and record them in Risk Assessment format. 
• Risks identified as part of the Context of the Organization are recorded in the Risk Assessment format for Top Management 
• The methods for risk assessments vary, but should always include a means of identifying the risk under examination, and a description of the result of the risk assessment.
• Detailed methods may include FMEA (failure mode effects analysis), SWOT (strength, weakness, opportunity and threat) or other tools. But right now we are not following these methods and use simple method of identifying risk and taking actions to reduce or eliminate the risk & to increase or encourage the opportunities.
• When doing the risk treatment an entry shall be made in the Risk format. When using the Risk format , the following steps are to be followed
• Identifying the risk.
• Identifying the process for which the risk most likely dominates.
• After entering the Risk in Risk Assessment format, the concerned management will decide whether to reject the subject due to the risk, or accept the risks after the development of a risk mitigation plan. The mitigation plan must be documented, either in the Risk Assessment format.
• The concerned Management will review & revised the Risk Assessment time to time
• If a risk includes a potential positive aspect, management may elect to conduct an opportunity pursuit assessment on the positive aspect, as defined below.

PROCEDURE: MANAGEMENT OF OPPORTUNITIES

XXX actively seek out opportunities which could enhance its financial viability and market position. For example:

• obtaining new contracts
• obtaining access to new markets
• identification of new industries which may be served by XXX 
• development of new offerings that are within the scope of capabilities of XXX
• streamlining existing processes to improve efficiency and reduce costs

Opportunities are identified as part of the “Context of the Organization Exercise” and as part of the corrective action program. Discussing and analyzing opportunities shall be done by top management. If made part of the management review activities, these shall be recorded in the management review records.

To help determine which opportunities should be pursued, the Opportunity column within the Risk Assessment form may be used to conduct an “opportunity pursuit assessment.”

The opportunity pursuit assessment is conducted by:

• Identifying the opportunity.
• Identifying the process for which the opportunity most likely falls under.

For opportunities recorded in Risk & Opportunity Form, management will decide whether to pursue the opportunity through an “opportunity pursuit plan” or to abandon the opportunity altogether. The opportunity pursuit plan must be documented, either in the Risk & Opportunity form.

Analysis of any opportunity will generally result in one of the following possible determinations:

• Pursue the opportunity
• Explore the opportunity in greater detail before proceeding
• Accept the opportunity, but under limited and controlled conditions
• Decline the opportunity, typically based on a high expected cost or low anticipated benefit

If an opportunity includes a negative aspect, management may elect to conduct a risk assessment on the negative aspect, as defined above.

7. RETAINED DOCUMENTED INFORMATION

7.1 Risk and Opportunity Register
7.2 Management Review Record

For example of the Risk and opportunity click here

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1. SCOPE

This procedure defines the various steps taken to plan, audit, and report internal audits of the Quality Management System at XXX. In addition, it also includes the provision for conducting follow up audits to verify effective closure of non-conformances raised during the internal audit(s)

2. PURPOSE

The purpose of this procedure is to ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2 ISO 9001:2015 standard
3.3 ISO 19011:2018 standard

4. TERMS & DEFINITIONS
MR- Management Representative
NC- Non-conformity ie non-fulfilment of a requirement
SOP- Standard Operating System

5. RESPONSIBILITY AND AUTHORITY

5.1 Management Representative
5.2 Internal Quality Auditors
5.3 Auditees

6. DETAILS OF PROCEDURE

6.1 Audit Planning

6.1.1 Internal Audits of the QMS are planned and controlled by the Management Representative. The MR maintains an Annual Audit Plan. The audits are planned in such a way that the entire scope of the QMS is covered at least once every 6 months. The audit plan and schedule developed takes into consideration the results of XXX activities, the importance of the company’s operation(s) concerned as well as the results of previous audits.

6.1.2 Internal audits are carried out by trained & certified auditors. A list of trained & certified auditors is available with the MR. Audits are planned as such that auditors do not audit their own work. Selection of auditors and conduct of audits shall ensure objectivity and the impartiality of the audit process. The audit schedule is communicated to all concerned in the format defined.

6.1.3 The MR ensures that the Internal audits are based on the documented QMS that includes Policy, Objectives, Manual, System Procedures, and Other applicable Documents and Records.

6.1.4 The auditors may prepare appropriate checklists to be used as aides- memoir while conducting the audit. ISO 9001:2015 standard shall also be referred by Auditor while preparing the Audit Checklist.

6.2  Auditing and Reporting

6.2.1 Internal audits are carried out through a process of review of documents, records, observing the activities, and interviews with people within the area being audited. The focus is on compliance, effectiveness as well as adequacy of the system.
6.2.2 On completion of the audit, the auditor will discuss his/her findings with the auditee and agree on the identified non-conformances and observations.
6.3.3 The MR will prepare the final Internal Audit Report and obtain the signature from
6.3.4 The Auditor will record the Non-conformance in the Corrective Action Request for necessary correction and corrective action. The MR will review the corrective action-filled by Auditee and discuss the corrective action with the department manager & auditor.
The report also has a provision for recording the root cause analysis as applicable considering the impact of the detected non-conformance and the corrective action plan including the target date of completion, which the Auditee will record.
6.2.5  The auditor then submits the correction, corrective action requests to the MR who records the same in the Corrective Action Tracker such that he/ she can track the open non-conformances for earliest closure.
6.2.6 The MR reviews the Corrective Action Tracker monthly and requests the respective auditor to verify effective closure of non-conformances through a follow-up audit.

6.3 Follow up Audits

6.3.1 The respective internal auditors shall conduct a follow-up audit to verify the effective closure of the non-conformance and based on the facts verified and record their comments on the Corrective Action Request. The report is submitted back to the MR.
6.3.2 MR updates the status of the non-conformance in the Corrective Action Tracker as open or closed. MR uses this tracker to generate a report on internal audits for the Management Review.
6.3.2 After every internal audit cycle, the MR reviews the reports and, if required, holds a debrief session for the auditors to provide feedback and tips on improving the audit process. This audit procedure is reviewed for its effectiveness, and revised if required.

7. RETAINED DOCUMENTED INFORMATION

7.1 List of Trained & Certified Auditors (QMS F002)
7.2 Audit Plan (QMS F003)
7.3 Audit Schedule (QMS F004)
7.4 Corrective action request (QMS F001)
7.5 Corrective Action Tracker (QMS F005)
7.6 List of Trained & Certified Auditors (QMS F006)
7.7 Internal Audit Report (QMS F007)
7.8 Internal Audit Schedule (QMS F008)
7.9 Internal Audit checklist (QMS F009)

1. SCOPE

This procedure covers the detection of non-conforming products within XXX operations and taking the necessary corrective or preventive action to avoid unintended use or delivery.

2. PURPOSE

The purpose of this procedure is to ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2 Public Procurement and Disposal Act,2015
3.3 XXX Strategic Plan

4. TERMS & DEFINITIONS

4.1  D –  Director
4.2 MR –  Management Representative
4.3 NCP –  Non-conforming product
4.4 SOP  – Standard Operating Procedure
4.5 Non-Conformity – Non-fulfilment of requirement.

5. RESPONSIBILITY AND AUTHORITY

5.1 Director

1. Appoint the disposal committee members.
2. Authorize disposal of non-conforming products.
3. Overall responsibility for the determination of appropriate disposition method for non-conforming products.

5.2 Deputy Directors/ Centers Directors/ Departmental Heads /Stores Officer /Other Staff

1. Responsible for control of the non-conforming products in their unit.

6. DETAILS OF PROCEDURE

6.1 Detection of Non Conformity

6.1.1 Non-conforming products are detected through any of the following activities:-

• Protocol and manuscript review.
• Inspection and testing.
• Customer feedback and complaints handling.
• Quality audits.
• Procurement process.
• Service delivery.

6.1.2 Identify/label and quarantine the non-conforming products.
6.1.3  XXX shall deal with nonconforming outputs in one or more of the following ways:

1. Correction
2. Segregation, containment, return or suspension of provision of products and services;
3. Informing the customer;
4. Obtaining authorization for acceptance under concession.

6.1.4 Where non-conformity is detected during processing, it is suspended until action is taken to eliminate the detected nonconformity.
6.1.5 Where non-conformity is detected in protocols and manuscripts, it is referred back for effecting of suggested corrections or rejected outright.
6.1.6 Where non-conformity is detected during handling/delivery further processing/delivery will be suspended until action is taken to eliminate the cause of the non-conformity.
6.1.7 Non-conforming products detected during quality audits or inspections are recorded on corrective action request forms as non-conformity.
6.1.8 Where a concession is allowed on supply or receipt of a product that does not certain specifications/characteristics a concession form is filled.
6.1.9 The relevant process owner shall review and investigate the non-conformance.

NOTE 1: All non-conformances shall be closed out without undue delay.

7.0 Process Flow Chart

8. RETAINED DOCUMENTED INFORMATION

7.1 Corrective Action Request Form QMS F001
7.2 Concession request form – QMS F012

A quality manual is a document that states the company’s intentions for operating the processes within the quality management system. It can include policies for all areas of the business that affect your ability to make high-quality products and meet your customers’ and ISO’s requirements. These policies define how your department managers will implement procedures within the boundaries specified in the quality manual. The use of the Quality Manual is as follows:

1. To communicate management’s expectations to employees
2. To demonstrate the company’s plan to conform to the requirements of ISO 9001:2015
3. To demonstrate the fulfilment of Clause 5.3, that organizational roles, responsibilities and authorities are assigned, communicated and understood
4. To provide a starting point for auditors:
   1. Internal
   2. Customer
   3. ISO Certification Body

To develop a quality manual, you might consider these steps:

1. List policies to be written (note any ISO requirements that do not apply).
2. Draft policies based on applicable ISO requirements.
3. List operating procedures or refer to them as appropriate.
4. Determine the format and structure of the manual and make the first draft.
5. Circulate the draft manual for input from all departments and address inadequacies identified.
6. Attain a formal approval and release.

The contents of your quality manual are completely up to you. But, remember that everything you say you do, you must show evidence that you really do it! So be careful what you include and make sure the policies reflect actual practices. Here are some common topics included in quality manuals.

• the scope of QMS
• Quality policy
• Explanation of the company’s documentation structure
• Organizational chart
• Policy statements for each applicable ISO requirement
• Reference to operating procedures

1) The scope of the Quality Management System. This is in place to identify the limit of the system and is based on the scope agreed with the registrar to be placed on the ISO9001 certificate. This is the explanation of what your company does, be it “Design and Manufacture of the Bevel Gear,” “Machining Services for Customers in the oil and service Industry,” or “Providing Fast Food for People in Kuwait city.” The second part of the scope requirement is to identify any exclusions from the standard. In many cases, the Quality Manual will identify none, but the most common exclusion is the requirement of the ISO 9001 standard for “Design & Development” for companies such as a machining shop, which works exclusively from customer drawings and does not design any products itself.

2) The documented procedures established for the Quality Management System (or references): ‘Documentation’ means anything written down or captured in some form such as written procedures, policies, checklists, forms, or graphics, drawings, flowcharts, diagrams, IT systems. This is called ‘documented information’ in the current version (2015) of ISO 9001. Confusingly, they have also decided to use the same term for what was formerly called ‘records’ – those things that showed what had been done, such as registers, logs, competed for forms, reports, meeting minutes, and so on. ‘Documented information in 9001 terms means both the ‘written stuff’ that describes your quality system and say how it should operate (eg, flowcharts, procedures, policies, checklists) and the ‘written stuff’ that shows what was done. A system must be documented to achieve ISO 9001 certification because having certain documented information is required by the Standard.  All the documents need to control how things are done, whether procedures, flowcharts, checklists, forms, IT systems, or any other media or format that work in your business. But note that no mandatory procedures are prescribed. Nor a quality manual. What can confuse people is that actually, you can choose what your documents look like, what format and structure you use, and what to put in them. Provided you meet these requirements. You can use one or many formats, from checklists and flowcharts to intranets, wikis, or workflow embedded into IT systems. You can use any media, hardcopy or soft, including intranet, online, internet, or wiki. One often-used way to do that was with a thing called a ‘quality manual’. And you can still do that if you choose. And it can be in hard copy (paper) or softcopy: online documents like web pages, help files, or IT systems. And you can write your document in various ways, from easy and user-friendly to bureaucratic, verbose, and very hard to follow. And such a manual may be the only document you have for your system, or it may be one of a number of documents. Or something in between.

3) A description of the interaction of processes. This is most simply done with a flowchart that identifies all the processes in the organization with arrows showing how they connect. While an in-depth flowchart may help you to better understand the interactions between processes in your organization, a simple top-level flowchart is all that is needed for most people to understand the basics.

Example of Quality Manual

1.0 Company Profile

Include your company profile

1.1 The mission of the Firm

Our mission is to enhance mobility through innovation, leadership, and public service. Innovation by providing unparalleled value combined with flexibility and risk-taking ability, leadership by delivering exceptional performance in every domain, and corporate responsibility through service to society.

1.2 The vision of the Firm

To strive relentlessly with an aim to achieve excellence in all businesses that we venture into, with the objective of becoming an organization that all its employees and associates are proud of.

2.0 Organization Scope

 Design, Development of Land, Construction Sales of Residential and Commercial Complexes 

2.1 Exclusions:

NIL

2.1 Quality Policy

XXX is committed to delivering quality construction work with promised amenities, in time possession, which meets and exceeds the needs & expectations of our customers. We promise our valued customer’s commitment to excellence in each activity by each employee in the organization by adopting innovative and best in class engineering and management practices with continual improvement in business and quality management system as a part of our efforts for enhancement in customer satisfaction while assuring 100% quality and quantity.

2.2 Key Objectives

• Timely completion of projects
• Increase Customer satisfaction
• Reduce Customer Complaint

3.0 Glossary & Abbreviations

Sr.No.	Abbreviation	Description	Sr. No.	Abbreviation	Description
1	XXX	Name of  Company	18	ASL	Approved supplier list
2	QSM	Quality System Manual	19	PDIR	Pre Despatch Inspection Report
3	DI	Documented Information	20	MME	Measuring & Monitoring Equipments
4	CFT	Cross-Functional Team	21	ISO	International Organizational for Standardization
5	CH	Chart	22	MKT	Marketing
6	CP	Control Plan	23	QA	Quality Assurance
7	FG	Finished Goods	24	PUR	Purchase
8	QF	Quality Format	25	STR	Stores
9	SYS	System	26	PRD	Production
10	IA	Internal  Audit	27	HR	Human Resource
11	List	List	28	MNT	Maintenance
12	NC	Non Conformance	29	DD	Design and Development
13	CA	Corrective action	30	LOI	Letter of Indent
14	OK	Organizational Knowledge	31	MI	Measurement traceability
15	NCP	Non-Conforming Product	32	PI	Performance evaluation
16	NCR	Non Conformance Report	33	MRM	Management review meeting
17	EP	External provider	34	IP	Interested Parties

4.0 Context of Organization

4.1 Understanding the organization and its context:

Shah Promoters and Developers determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system through PEST and SWOT. The external and internal issues identified through PEST and SWOT are continuously being monitored and reviewed by the CEO.

PEST

Political Factors (P)   Political direction on Smart Cities Allocation for Infrastructure Skill enhancement in Automation Sector Monetary policies	Economic Factors (E)   The growth of banks in rural areas Funding for smart cities Increase in car park density High GDP growth
Social Factors (S)   Increased literacy Technological awareness Banking on banks Increased per capita income	Technology Factors (T)   Advancement in chip design Automation tools growth High technology at low cost Digital technology growth

SWOT

Strength (S)   Strong technology backup Young and motivated team Nil borrowing Quick decision making Strong customer focus	Weakness (W)   Very small team Lack of experience Weak marketing High inventory Limited customer base
Opportunity (O)   Lean organization leads to Flexibility in products Quick response to customer needs Low level of competition High growth potential	Threat (T)   High technology imports Skill development velocity Increased competition Technology leakage Attrition

4.2- Understanding the needs and expectations of interested parties

xxx has determined the interested parties who are relevant to the xxx Quality management system and the requirement of the interested parties in order to prevent the potential effect on the organization’s ability to consistently provide products and services which meet the customer and applicable statutory and regulatory requirements.

Interested parties	Requirements	Monitoring & Review mechanism
External providers	Specification communication Payment as agreed On time Supply of Input material (if any) Technology  support	Defined in the Documented information of External providers control Review in Management review meetings
Customer	Quality of product & Service Delivery of product on  time Response to complaint Proper Communication channel	Defined in the documented information of Marketing & Sales process Review in Management review meetings
Statutory & Regulatory Body	Complying with the statutory and regulatory requirements as defined from time to time.	Defined in the documented information of Leadership Review in Management review meetings
Bankers / Financiers	Updating of changes in the organization whenever it happened	Review in Management review meetings
Employees	Management Support, Payments on time	Accounting Control of management

4.3 Determining the scope of the quality management system

The organization had determined the scope of the Quality management system by considering external and internal issues, the requirement of relevant interested parties and Product & Service of the organization.

The scope of Quality Management System is

Design, Development of Land, Construction Sales of Residential and Commercial Complexes 

Exclusions:

NIL

4.4 Quality management system and its processes

4.4.1: xxx has determined the processes needed for the quality management system and their application throughout the organization in Process map & Interactions of processes.

xxx has determined the inputs required and the outputs expected from each process in an individual process map addressed in the documented information of each process.

xxx has determined the sequence and interaction of the processes in Process map & Interactions of processes.

xxx has determined and applied the criteria and methods (including monitoring, measurements, and related performance indicators) needed to ensure the effective operation and control of these processes in the documented information of each process.

xxx has determined the resources needed for these processes and ensures their availability in the documented information of the Support process.

xxx has assigned the responsibilities and authorities for each process

xxx has addressed the risks and opportunities

xxx has been evaluating these processes and implementing any changes needed to ensure that these processes achieve their intended results and improve the processes and the quality management system

Improve the processes and the quality management system

4.4.2- xxx is also maintaining documented information to support the operation of its processes and retaining documented information to have confidence that the processes are being carried out as planned.

5.0 Leadership

5.1 Leadership and commitment

 Xxx Management has demonstrated leadership and commitment with respect to the quality management system through

1. Taking accountability for the effectiveness of the quality management system by periodical review of quality management system through management review meeting, Quality objectives review and providing necessary resources.
2. 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.
3. Management has determined the organizational processes and integrated with the quality management system requirement through process map & Interaction this can be demonstrated.
4. The established procedure for promoting the use of the process approach and risk-based thinking.
5. Ensuring that the resources needed for the quality management system are available, this is being periodically reviewed through management review meeting.
6. Communicating the importance of effective quality management and of conforming to the quality management system requirements
7. Ensuring that the quality management system achieves its intended results
8. Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system by providing training, conducting awareness programs and
9. Promoting improvement by introducing the suggestion scheme, Kaizens and conducting meetings.
10. Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

5.1.2 Customer focus

Xxx management has demonstrated leadership and commitment with respect to customer focus by ensuring that:

1. Customer and applicable statutory and regulatory requirements are determined, understood and consistently met.
2. The risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed

 c) The focus on enhancing customer satisfaction is maintained and procedure for customer satisfaction is addressed

5.2 QUALITY POLICY

XXX is committed to delivering quality construction work with promised amenities, in time possession, which meets and exceeds the needs & expectations of our customers. We promise our valued customer’s commitment to excellence in each activity by each employee in the organization by adopting innovative and best in class engineering and management practices with continual improvement in business and quality management system as a part of our efforts for enhancement in customer satisfaction while assuring 100% quality and quantity. We are also committed to serving society as a whole by generating through a clean development mechanism (CDM) project.

 5.2.1 Establishing the quality policy

 Xxx management has established, implemented and maintained a quality policy that:

1. is appropriate to the purpose and context of the organization and supports its strategic direction.
2. Provides a framework for setting quality objectives
3. Includes a commitment to satisfy applicable requirements
4. Includes a commitment to continual improvement of the quality management system

5.2.2 Communicating the quality policy

The quality policy is

1.  Available and be maintained as documented information
2. Communicated, understood, and applied within the organization through the display, Training, and periodical review.
3. Available to relevant interested parties, as appropriate.

5.3 Organizational roles, responsibilities and authorities

Xxx 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

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

Roles, responsibility and authorities assigned are available in process & as per Organization chart wise

Directors

Responsibility

• Overall Responsibility for formulating and communicating Quality Policy & Quality objectives.
• Formulation of Strategy for continuous up gradation of Business and Quality System.
• Ensure periodic assessment of the performance of Quality System.
• Approval of Quality System Manual.
• Budget Approval for the organization.
• Overall Responsibility for Business Development & all financial issues.
• Provision of resources as required.
• Strategic decisions on developments and technical setups.
• To provide the leadership for efficient implementations of the system.

Authorities:

• Approval of customers orders, P.O. and Cheque.
• Sanctioning leaves of all Staff.
• Approval of funds for Training needs.
• All the authorities of downline personnel.
• Chairing Management review meetings.

Project Planning

Responsibilities:

• Overall coordination between client, project managers and office department.
• Follow up for Schedules.
• The entire responsibility of Quality.
• Monitoring Client Satisfaction.
• Coordination with the consultants.
• Disciplinary actions against the staff.
• Prime responsibility for the safety at the site
• Provision of a suitable working environment
• Ensure the quality system is established, implemented and maintained.

Authorities:

• Appointment of the staff, engineers and tech staff.
• Sanctioning the Leaves to Staff.
• All the authorities of downline personnel.

Project Managers

Responsibilities:

• Responsibilities for the entire Project work, i.e. Quality, Quantity and Time.
• Coordination with consultants and contractors.
• Coordination with Consultants for drawings.
• Coordination with the Site engineers.
• Coordination with the client for the ongoing changes in drawings and projects.
• Monitoring site engineers work on a daily basis.
• Reporting to the GM Projects on the above issues
• Responsibilities for safety at the site. (Good working environment).

Authorities:

• Make or force a required decision at all levels to achieve project objectives.
• Initiate actions on the Contractors and consultants for Quality, Quantity and Timeframe issues related to project work.
• To stop and initiate corrective actions on non–confirming products/services.

Site Supervisor

Responsibilities:

• Coordinating with all staff for the Quality related issues of Construction.
• Daily Labour Handling for Civil Work.
• Monitoring of Work progress and daily reporting.
• Preparation of work progress report / Quality Documentation.
• Control of non – conformities on site
• Safety at site / Construction work.
• Coordination with the Site Contractor for the daily work requirements.
• Coordination with external agencies for calibration of instruments and material testing.

Authorities:

• Initiate actions on the staff for non-fulfillments of the documentation related quality
• To stop and initiate corrective actions on non–conforming products.

 Site engineer

 Responsibilities:

•  Monitoring of site and labour contractors.
• Monitoring of work progress and daily reporting
• Preparation of work progress report.
• Control of non – conformities on site.
• Ensuring instruments are properly used and are with the status of calibration.
• Track Project progress & produce regular weekly status reports.
• Coordinate with all labour contractors to achieve continuous progress at the site as per schedule.
• Follow up with the Project manager for pending decisions/drawings/building specifications.
• Communicate management decisions and information to Site subordinate staff.
• Ensuring the worker’s safety at site and usage of safety equipment.
• Implementation and follow up and regular monitoring of implemented ISO 9001 system at the site.
• Coordination with the Quality Person for Quality related issues.
• Coordinating Material Accountability at site

Authorities:

• Initiating the corrective and preventive actions as needed on contractors and consultants.
• Decision making on during any emergencies at the site.

In-charge Marketing:

 Managing & motivating the sales force towards the achievement of target.

• Preparation of Sales plan.
• Annual sales forecast.
• Monthly sales forecast.
• Implementation of sales plan.

Authorities:

• Approval of documents as per the Master list of Quality System Document.
• Authorized to decide corrective & preventive action.
• Authorized to obtain concessional acceptance for non – conforming product from the customer.

InCharge – ADMIN + ACCOUNT

Responsibilities: 

• Responsible for tendering activity.
• Customer order review.
• Handling and coordinating customers
• Identification of resources, as applicable.
• Document & Data control system pertaining to his department.
• Maintain all documents related to the quality system.
• Coordinator for Management reviews.
• Promoting awareness of customer requirements throughout the Organization.
• Compliance & effectiveness of the training system.
• Suitable working environment (cleanliness, ventilation, lighting, safety etc.).
• Record maintaining for Sales Register, Rent Register, Sale Files, Stationery and Office equipment.
• Archiving and record keeping of old files.
• Payroll Monthly: Salary –To release monthly salary of the employees as per policy finalized.
• Leave – To keep the record of leave as per policy finalized.
• Annual Allowance – To release annual allowances as per policy finalized.
• Employee Record – To update employee details as per organization Policy and QMS.
• To prepare an appointment letter, confirmation letter, experience letter & all employee-related matter as per policy finalized with the help of the Managing Director.

Authorities:

• Approval of customer orders.
• Approval of documents as per the master list of Quality System Document.
• Authorized to decide corrective & preventive action.

 In charge Purchase:

Responsibilities:

• Overall in charge of purchase activities.
• Identification of resources, as applicable.
• Purchasing system – Evaluation, selection, purchasing, monitoring.
• Document & Data control system pertaining to his department.
• Corrective / Preventive action system (subcontractor non-conformances, in particular.)
• Control of records

Authorities:

• Authorized to review & approve purchasing documents.
• Authorized to select & discontinue sub-contractor

6.0 Planning

6.1 Actions to address risks and opportunities

6.1.1

Xxx is addressed the issues, requirements the risks and opportunities

1. give assurance that the quality management system can achieve its intended result(s)
2. Enhance desirable effects
3. Prevent, or reduce undesired effects
4. achieve improvement

6.1.2

1. actions to address these risks and opportunities
2. How to
   1. integrate and implement the actions into its quality management system processes
   2. Evaluate the effectiveness of these actions

Interested parties	Requirements	Risks and Opportunities	Effectiveness of actions
External providers	Communication, Payment Terms, On Time Supply, Technology  Support,	Communication Gap,  Payment  & Delivery terms not in written, Output Failure	Communication like  Emails, Phone, Payment  & delivery terms mention in PO, Documented information is provided for Technical  support
Customer	Product Quality, Delivery & service of  on  time,  Response to the complaint, Proper Communication channel	Business Loss, Reputation Down for Organization	Defined in the documented information of Marketing & Sales process & Review in Management review meetings
Statutory & Regulatory Body	Organization & product related Statutory & regulatory requirements are kept	The customer is not acceptable material or loss of business	Defined in documented information & Review in Management review meetings
Bankers/financiers	All product & organization related documents are kept	The organization is facing the problems (funds related)	All product & organization related documents are kept
Employees	On time Payments	Work is not properly operated	On time payments issue to employees
Marketing	Competitive rates, More amenities, Prime Location,	Organization facing problems in sales, Reputation in market	Market analysis, Competent marketing team.
Purchase	Competitive rates, Good Quality material, Timely Delivery,	The organization facing Finance problems, Customer dissatisfied, Delay in project completion &  Reputation in market	Market analysis, Competent   Purchase team

6.2.2 Quality objectives and planning to achieve them

 6.2.1  Xxx establishes quality objectives at relevant functions, levels, and processes needed for the quality management system.

The quality objectives shall

1. Be consistent with the quality policy
2. Be measurable
3. Take into account applicable requirements
4. Be relevant to the conformity of products and services and to the enhancement of customer satisfaction
5. Be monitored
6. Be Communicated
7. Be updated as appropriate

6.2.2 Xxx achieve its quality objectives,

1. What will be done?
2. What resources will be required?
3. Who will be responsible?
4. When it will be completed
5. How the results will be evaluated

Our Quality Objectives are as below:

• Timely completion of projects
• Energy Generation Per Year
• Increase Customer satisfaction
• Reduce Customer Complaint

6.3 Planning of changes

Xxx determines the need for changes to the quality management system, the changes are carried out in a planned manner

1. the purpose of the changes and their potential consequences
2. the integrity of the quality management system
3. the availability of resources
4. the allocation or reallocation of responsibilities and authorities

Xxx has determined the processes needed for the quality management system and their application throughout the organization in Process map & Interactions of processes

7   Support

7.1 Resources

7.1.1 General

Xxx is determined and provides the resources needed for the establishment, implementation, maintenance, and continual improvement of the quality management system. Xxx is consider

1. the capabilities of, and constraints on, existing internal resources
2. what needs to be obtained from external providers

HR  determine and provide the resources needed to implement and maintain the quality management system and continually improve its effectiveness and to enhance customer satisfaction by meeting customer requirement. The resources will be in the form of

• Human resources including qualified personnel for verification activities.
• Manufacturing machines, Test Equipment’s & infrastructure.
• Provide raw material & other inputs for the realization of the product.
• Providing funds.

The Required resources are identified in the event of new Process Development / Business plan review, Mfg Process Flow, also based on the Organization performance review in MRM and monthly business reviews.

7.1.2 People

Xxx determines and provides the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes. HR along with respective processes IN CHARGE ensures that personnel performing work affecting product quality is competent and training to give on the basic operation and control of its processes.

7.1.3 Infrastructure

Xxx is determined, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. Infrastructure can include

1. buildings and associated utilities
2. equipment, including hardware and software
3. transportation resources
4. information and communication technology

At Xxx management determine, provide and maintain the infrastructure needed to achieve conformity to product requirements & in identifying the required resources the PARTNER play a key role based on their day to day  interactions with respective IN CHARGE’s and employees

7.1.4 Environment for the operation of processes

Xxx is determined, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. A suitable environment can be a combination of human and physical factors

1. Social (e.g. non-discriminatory, calm, non-confrontational)
2. Psychological (e.g. stress-reducing, burnout prevention, emotionally protective)
3. Physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).

Project in coordination with respective IN CHARGE determines and manages the work environment needed to achieve conformity to product requirement and reviewed ongoing basis.

7.1.5 Monitoring and measuring resources

7.1.5.1 General

Xxx is determined and provides the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided

1. are suitable for the specific type of monitoring and measurement activities being undertaken
2. are maintained to ensure their continuing fitness for their purpose

Xxx is retained appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources

7.1.5.2 Measurement traceability

Xxx is measurement traceability is maintained requirement if applicable for the instruments or is considered by them to be an essential part of providing confidence in the validity of measurement results,

1. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information
2. identified in order to determine their status
3. safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results

Xxx is determined the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.

Control of Monitoring & Measuring Equipments.

The measurement & Monitoring system is well equipped and the system has complete control over the monitoring and Measuring Equipment. The measurement methods used are evaluated to ensure that they are appropriate and reliable. To ensure that the measuring equipment operates effectively and give reliable results, we have taken the following steps:

• Equipments are maintained properly and are calibrated & adjusted as and when needed. Necessary safeguards are in place to take care of adjustments that could lead to invalid results.
• Calibrations are carried out as per national standards (by NABL accredited laboratories only). Where no such standard exists, the basis used for calibration or verification is recorded. The calibration records include the last date of calibration, calibrating agency (for the external agency), calibration result, and frequency of calibration as per the process and/or instrument requirement and the next calibration date. The required accuracy is identified and compared to the measurement that meets expectations.
• Identification of appropriate equipment is accomplished by tagging, labelling, numbering or by including it in a calibration/maintenance database.
• Proper control is maintained to ensure that no faulty equipment is used, the reliability of the equipment is ensured through routine maintenance and re-calibration.
• Equipments are used, handled and stored under conditions that protect the accuracy and prevent. Unauthorized adjustment. Work environmental controls are all in place for equipment.
• Instrument history cards are maintained for all measuring & Test Instruments.

Laboratory Requirements

 Internal Laboratory

The internal laboratory is available as on date the various test is carried out as per customer requirement, standard specification and internal laboratory test procedure are available & the record is kept.

External Laboratory

• External / Commercial/independent laboratory facilities used by IM will be accredited laboratory facilities to NABL or NPL or as accepted by the Customer.
• Evidence of acceptance by national accreditation or customer shall be kept.

7.1.6 Organizational knowledge

Xxx is determined the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge shall be maintained and be made available to the extent necessary. When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. Organizational knowledge is specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives.

Organizational knowledge can be based on:

1. Internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services);
2. External sources ( e.g. standards; academia; conferences; gathering knowledge from customers or external providers).

7.2 Competence

Xxx is

1. Determine the necessary competence of person(s) doing work under its control that affects the Performance and effectiveness of the quality management system
2. Ensure that these persons are competent on the basis of appropriate education, training, or Experience
3. Where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken

Retain appropriate documented information as evidence of competence for all  employees

7.3 Awareness

Xxx is ensured that persons doing work under the organization’s control are aware of

1. The quality policy
2. Relevant quality objectives
3. Their contribution to the effectiveness of the quality management system, including the benefits of improved performance
4. The implications of not conforming to the quality management system requirements

7.4 Communication

Xxx is determined the internal and external communications relevant to the quality management system, including

1. On what it will communicate
2. When to communicate
3. With whom to communicate
4. How to communicate
5. Who Communicates

INTERNAL COMMUNICATION
What	When	with whom	How	Who
Quality policy	Permanent	All Employees  / Interested parties	Display / Letter / Training	Management
Importance of effective QMS	As per the Training plan / during Orientation training	All Employees	Training / Display	Management
Responsibilities and Authority	During recruitment / Promotion / Department change	Employee	Procedure / Oral / Training	Management
Quality objectives	While defining / Once in 3 months	All employees	Procedure / Oral / Training	Management
Customer complaint / Feedback	At the time of receipt	Head of the department / Respective process owner	Meeting	Director

External COMMUNICATION
What	When	with whom	How	Who
Information to external providers	Placing purchase order / Quotation collection	Supplier (External provider)	Purchase order / Letter / Email / Oral	Purchase I/C
Product information	Enquiry stage	Customer	Email / Website / Catalogue / Letter	Director
Enquiry, order, amendments	Enquiry review / Order review	Customer	Electronic media / Letter/ oral	Director
Customer feedback	Once in a year / After service	Customer	Forwarding customer feedback form	Director
The action is taken for customer complaints	Once the action is taken	Customer	Electronic media / Letter/ oral	Director
Information to external providers	As agreed with the customer	Customer	Delivery challan / Letter / Email	Stores I/C

7.5 Documented information

7.5.1 General

7.5.2 Creating and updating

XXX creating and updating documented information, the XXX is ensured appropriate

a) Identification and description

b) Format (e.g. language, software version, graphics) and media (e.g. paper, electronic)

c) Review and approval for suitability and adequacy 

XXX’s quality management system is included

Quality Management System documentation is established with the following approach. A four-level-documented structure is followed for the operation of the Quality Management System.

L-1	QUALITY MANUAL (Standard Requirement)
L-2	PROCEDURES
L-3	PROCESS FLOW CHART, WI, QUALITY PLANS, CHECKSHEETS, MANUFACTURING PROCESS FLOW CHARTS
L-3	DOCUMENTED INFORMATION

• Level 1: Quality Manual (standard Requirement) Defines the approach and responsibility, which includes a documented statement of quality policy & objectives etc.
• Level 2: Procedures
  Defines what, where, when, who & why of an activity being done as stated in ISO- 9001:2015 standard. The documented procedure activity process flowchart defines the effective planning, operation and control of processes.
• Level 3: WI, Quality Plans, Check sheet etc
  Defines how exactly an activity is to be done ensuring the effective planning, operation and control of processes.
• Level 4: Documented Information
  Provides the evidence, which has to be established for all the activities, stated above which In turn Documented Information.  A master list of Quality Record is maintained by respective Departments/ section heads as per the requirement of ISO 9001:2015.

Control of Quality System Manual.

• Partner is approved the Quality Manual, procedure, WI & documented Information and its amendments.
• Management Representative / Quality In charge is responsible for the preparation, review, issue & control of the manual and its amendments.
• In case any person ceases to be the holder of manual copy for any reason, his copy number of manual will be allocated to any new holder with the note in amendment list to this effect.
• MASTER COPY will be stamped “MASTER” on the front side of all pages in “BLUE”
• A photocopy will be taken for all MASTER & will be “CONTROLLED” stamped in RED MR/Quality in charge maintains the master copy having original signatures.

 Document changes.

MR/Quality in charge perceives the need for the amendment to this manual based on the adequacy audit report, mistake/corrections during review by any holder, system change, and an amendment to reference ISO standard or any change in the organization affecting system described in this manual. Amendments to this manual are recorded in the Amendment list (After Amendment).

The holders of the Quality System Manual refer to the amendment list before referring to respective amended sections to clearly understand the details/purpose of the amendment. A list indicating the latest revision status of each page of this manual, whenever a page of any chapter is amended, the page and the chapter bear the latest Rev. No. The latest revision no. is indicated in the amendment sheet, and on the cover page of the Quality Manual. The revised version of the document pages is sent only to the holders as along with the updated amendment list and revision status page.

Controlled copyholders of this manual should ensure that the obsolete pages are removed & destroyed and revised pages are inserted in the Manual at appropriate places. Management Representative / Quality In-charge maintains one copy of the obsolete version of revised pages at the time of each amendment for reference purposes and having the OBSOLETE stamp in RED color. When the Rev. No. Of the Amendment, sheet reaches 09, or in case an amendment to ISO standard is released, the entire manual will be reissued and bear the next serial number of issue no. No details of amendments to earlier issue and recorded in amendment list for the new issue.

Numbering Logic Of Quality System Manual :

The numbering logic of this quality system manual will be as described here:

1. The numbering logic will be -QM-XX.
2. indicates xxx.
3. QM indicates Quality System Manual of ISO 9001:2015.

7.5.3 Control of documented information

7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure

1. It is available and suitable for use, where and when it is needed.
2. It is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity)

 7.5.3.2 For the control of documented information, xxx  is address the following activities, as applicable

1. Distribution, access, retrieval and use
2. Storage and preservation, including preservation of legibility
3. Control of changes (e.g. version control)
4. Retention and disposition

Documented information of external origin determined by the organization to be necessary for the Planning and operation of the quality management system is identified as appropriate and is controlled. Documented information retained as evidence of conformity shall be protected from unintended alterations.

8 Operation

8.1 Operational planning and control

Xxx will plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement the actions in & maintained risks and opportunities related to planning maintained in operational planning control. The bar chart for planning are

1. Determining the requirements for the products and services
2. Establishing criteria for
   1. The processes
   2. The acceptance of products and services
3. Determining the resources needed to achieve conformity to the product and service requirements
4. Implementing control of the processes in accordance with the criteria
5. Determining, maintaining and retaining documented information to the extent necessary
   1. To have confidence that the processes have been carried out as planned
   2. To demonstrate the conformity of products and services to their requirements

Xxx is control planned changes and reviews the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. Xxx is ensuring that outsourced processes are controlled.

 8.2 Requirements for products and services

 8.2.1 Customer communication

Communication with customers is include

1. Providing information relating to products and services
2. Handling inquiries, contracts or orders, including changes
3. Obtaining customer feedback relating to products and services, including customer complaints
4. Handling or controlling customer property
5. 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.

8.2.2 Determining the requirements for products and services

When determining the requirements for the products and services to be offered to customers, the Xxx is ensuring that

1. The requirements for the products and services are defined, including
   1. Any applicable statutory and regulatory requirements
   2. Those considered necessary by the organization
2. The organization can meet the claims for the products and services it offers

At present, the marketing activities are looked after by Marketing in charge and both of them are actively involved in the determination of customer requirements and for each enquiry, he determines the

• Requirements related to the product in contract review form with respect to requirements specified by the customer, including the requirements for delivery and post-delivery activities.
• Requirements not stated by the customer but necessary for specific or intended use (where Known)
• Statutory and Regulatory requirements related to the product
• Any additional requirements determined by the organization.

8.2.3 Review of the requirements for products and services

8.2.3.1 Xxx is ensuring that it has the ability to meet the requirements for products and services to be offered to customers. Xxx is conducting a review before committing to supply products and services to a customer, to include

1. Requirements specified by the customer, including the requirements for delivery and post-delivery activities.
2. Requirements not stated by the customer, but necessary for the specified or intended use, when known.
3. Requirements specified by the organization.
4. Statutory and regulatory requirements applicable to the products and services.
5. Contract/order requirements differing from those previously expressed

Xxx is ensuring that contract or order requirements differing from those previously defined are resolved. The customer’s requirements are confirmed by Xxx is before acceptance, when the customer does not provide a documented statement of their requirements

8.2.3.2 Xxx is retain documented information, as applicable

1. On the results of the review
2. On any new requirements for the products and services

• IN CHARGE MKT shall review the requirement related to the product. This review takes place as and when a new P.O or verbal order is placed/confirmed by the customer for a new part no. and prior to the commitment taken to supply the products.
• The review ensures that
  1. the product requirements are defined
  2. Contract/order requirements differing from those previously expressed in the proposal or quote are resolved.
  3. Our organization has the ability to meet the defined requirements

8.2.4 Changes to requirements for products and services

Xxx is ensured that relevant documented information is amended, and those relevant persons are made aware of the changed requirements when the requirements for products and services are changed

8.3 Design and development of products and services

 8.3.1 General

Xxx is establishing, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.

8.3.2 Design and development planning

Xxx is considering In determining the stages and controls for design and development, including

1. Nature, duration and complexity of the design and development activities
2. The required process stages, including application design and development reviews
3. The required design and development verification and validation activities
4. The responsibilities and authorities involved in the design and development process
5. The internal and external resource needs for the design and development of products and services
6. The need to control interfaces between persons involved in the design and development process
7. The need for involvement of customers and users in the design and development process
8. The requirements for the subsequent provision of products and services
9. The level of control expected for the design and development process by customers and other relevant interested parties.
10. The documented information needed to demonstrate that design and development requirements have been met.

8.3.3 Design and development inputs

Xxx determines the requirements essential for the specific types of products and services to be designed and developed. Xxx is consider

1. Functional and performance requirements
2. Information derived from previous similar design and development activities
3. Statutory and regulatory requirements
4. Standards or codes of practice that the organization has committed to implement
5. Potential consequences of failure due to the nature of the products and services

Inputs shall be adequate for design and development purposes, complete and unambiguous. Conflicting design and development inputs is resolved. Xxx is retain documented information on design and development inputs.

8.3.4 Design and development controls

Xxx is applying controls to the design and development process to ensure that

1. The results to be achieved are defined
2. Reviews are conducted to evaluate the ability of the results of design and development to meet requirements,
3. Verification activities are conducted to ensure that the design and development outputs meet the input requirements.
4. Validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use,
5. Any necessary actions are taken on problems determined during the reviews, or verification and validation activities.
6. Documented information of these activities is retained

8.3.5 Design and development outputs

Xxx ensure that design and development outputs

1. meet the input requirements
2. are adequate for the subsequent processes for the provision of products and services
3. include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria
4. specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision

Xxx is retain documented information on design and development outputs

8.3.6 Design and development changes

Xxx is identifying, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements. Xxx is retain documented information on

1. Design and development changes
2. The results of reviews
3. The authorization of the changes
4. The actions are taken to prevent adverse impacts

8.4 Control of externally provided processes, products and services (Purchase)

8.4.1 General

Xxx is ensuring that externally provided processes, products and services conform to requirements, Xxx determines the controls to be applied to externally provided processes, products and services when

1.  Products and services from external providers are intended for incorporation into the organization’s own products and services
2. Products and services are provided directly to the customer(s) by external providers on behalf of the organization.
3. A process, or part of a process, is provided by an external provider as a result of a decision by the organization

Xxx determines and applies criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.

IN CHARGE Purchase ensures that the purchased products are procured from Approved sources only and which conforms to specified purchase requirements. This is done as per the business process flow for PROCUREMENT. The type and control to be exercised on the supplier, based on the effect of the purchased product on the process/final product, is defined in the Approved Supplier List. IN CHARGE Purchase evaluates and select supplier based on their ability to supply product in accordance with the requirements of the organization. Criteria for selection, evaluation, and re-evaluation are described and depicted in the Business Process Flowchart.

1. Selection, Evaluation and approval of suppliers
2. Periodical evaluation of Supplier
3. Approved Supplier List will be maintained by the IN CHARGE Purchase and also the records of their periodical performance.

8.4.2 Type and extent of control

Xxx ensures that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers

Xxx is

1. Ensure that externally provided processes remain within the control of its quality management system
2. Define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output
3. Take into consideration
   1. The potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements
   2. The effectiveness of the controls applied by the external provider
4. Determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements

8.4.3 Information for external providers

Xxx ensures the adequacy of requirements prior to their communication to the external provider. Xxx is communicating to external providers its requirements for

1. The processes, products and services to be provided
2. The approval of
   1. Products and services
   2. Methods, processes and equipment
   3. The release of products and services

1. Competence, including any required qualification of persons
2. The external providers’ interactions with the organization
3. Control and monitoring of the external providers’ performance to be applied by the organization
4. Verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises

The Purchase order describes the product to be purchased including

1. Requirement of Material Test Certificate / Dimensional report / PPAP such as Control Plan / Process Flow Chart / Process Sheets / Process Capability studies etc.
2. Requirements for qualification of personnel
3. QMS requirements.

PO will be reviewed for adequacy of the specified requirement prior to release by IN CHARGE Purchase & M.R. The Purchase order released to the supplier indicates the intended verification arrangements and method of product release, whenever KWS or its customer intends to perform such verification at external providers end.

Incoming Product Quality

The control / Inspection plan for incoming be based on the control exercised on the external providers

1. Inspection and/or testing on sampling method. The sampling size should be decided based on past performance of the supplier.
2. Inspection at Sub-contractor’s premises with/without system audit.
3. Quality assurance certificate or the test report from the supplier.
4. Part evaluation by accredited laboratories.
5. Receipt and evaluation of statistical data.
6. Any of above method or Combination of any two or more from above.

Supplier Monitoring

External providers performance monitoring through the following indicators, & will be carried out by IN CHARGE PUR as described in Procedure for Purchase.

Delivered Product Quality.

• Delivery Performance.
• Customer disruptions including field Returns.
• Customer notification Related to quality Or delivery Issues
• Premium freight.

Xxx promotes monitoring of the performance of manufacturing processes of the external providers’ as part of supplier development.

8.5 Production and service provision

8.5.1 Control of production and service provision

Xxx is implemented production and service provision under controlled conditions. Controlled conditions include, as applicable

1. The availability of documented information that defines
   1. The characteristics of the products to be produced, the services to be provided, or the activities to be performed
   2. The results to be achieved
2. The availability and use of suitable monitoring and measuring resources
3. The implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services have been met
4. The use of suitable infrastructure and environment for the operation of processes
5. The appointment of competent persons, including any required qualification
6. The validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
7. The implementation of actions to prevent human error
8. The implementation of release, delivery and post-delivery activities

Production In-Charge shall plan the production as per and respective Section In-charge carry out the process under the controlled condition as defined in  Process Flow in respective process procedures. Controlled conditions shall include:-

1. Production plans for all processes which describes the characteristics of the product and process flow chart for the sequence of operations
2. Work Instructions made available at all workstations.
3. Use of appropriate equipment for a particular process/operation
4. Use of calibrated monitoring and measuring devices
5. In process inspection/verification
6. Verification of acceptance criteria

Production  Plan

The production plan for all stages of production, including receipt of the material sample, pilot & regular production shall be used. These Production plans at each stage may be amendments of production plans of the earlier stage. As described above, Marketing shall be involved in the preparation of production plans where required by customer production Plans will be submitted to the customer for approval. The production plan shall

• list the controls used for the manufacturing processes
• Include methods for monitoring of control exercised over special characteristics defined by both the customer and the organization.
• Include the customer required information if any
• Initiate the specified reaction plan when the process becomes unstable or not statistically capable production plans shall be reviewed and updated, as appropriate:
• The product is changed.
• The manufacturing processes are changed.
• The processes become unstable.
• The processes become non-capable.
• Inspection frequency and method changes
• Change in supply sources
• Corrective actions based on process NC,s & customer concerns
• Drawing changes / ECNs.

Production plans are developed for all the processes involved in the manufacturing by the Cross-functional team. These are identified during the advanced product planning process. Wherever approvable. The production plans are live documents and are reviewed and updated when the change to the original product or process occurs.

 Work Instructions

Respective IN CHARGE prepares Work Instructions for all operations/process activities and for all employees having responsibilities under them. These instructions are made accessible for use at the work station& are prepared based on trial run result and old documents of the similar product at the time of job induction into production and will be reviewed for applicable changes in event of production Plan change(s).

Preventive Maintenance

IN CHARGE MNT maintains a list of all machines/equipment used in production and designated key process equipment in the list. A plan for preventive maintenance for this key equipment shall be developed & implemented to ensure continuous process capability. This plan shall be based on the available data from the manufacturer’s recommendations, previous breakdown and preventive history, the extent of usage, and rate of wear and tear, etc., based on these details appropriate predictive techniques are used. IN CHARGE MNT ensures that required spare-parts for a replacement along with other resources for maintenance as per preventive maintenance schedule are available in time. Appropriate records of maintenance shall be maintained by IN CHARGE MNT. A system that describes the planned & predictive maintenance method is detailed in Procedure respectively.

Validation of processes for production and Service Provision

All processes are validated before the start of the production through set up approval and First Five Piece Inspection. The above processes are controlled and continually monitored through documented work instructions, process qualifications, set up approval, and worker qualification, as applicable to ensure that the specified requirements are met.

Appropriate records are maintained by All IN CHARGE to demonstrate the control of these processes and equipment. Records of personnel qualifications and re-qualifications are maintained by All IN CHARGE. Stipulate workmanship standards to the greatest practicable extent, where appropriate, by means of written standards, representative samples, or display boards.

Ensure Handling, Storing, and transporting within the production shop are carried to protect all materials/products.  The details of process controls are described in respective department procedures.

8.5.2 Identification and traceability

Xxx is used suitable means to identify outputs when it is necessary to ensure the conformity of products and services. Xxx has identified the status of outputs with respect to monitoring and measurement requirements throughout production and service provision. Xxx is controlling the unique identification of the outputs when traceability is a requirement and shall retain the documented information necessary to enable traceability.  All material is identified including inspection and test status inappropriate manner (paint, punch mark, labels, stickers, and tagging, etc.) from receipts at stores through various stages of production. The final product is kept on trolleys & transferred to the Finished Goods area before delivery to the customer as detailed in work procedures for storage, packing & dispatch procedure. Traceability is provided, if required by the customer or decided for some products by KWS to identify finished products by providing punch mark/tag/batch code. For such products, proper records are maintained also the main packages are traceable through the Barcode system.

8.5.3 Property belonging to customers or external providers

Xxx is exercise care with property belonging to customers or external providers while it is under the organization’s control or being used by the organization

Xxx identify, verify, protect and safeguard customers’ or external providers’ property provided for use or incorporation into the products and services

When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred

• Any arrangement of Customer Supplied raw materials, components, tooling, returnable packaging, measuring instruments, etc., are identified during the contract review by CFT/ IN CHARGE MKT and communicated to the people concerned.
• All such products are uniquely identified after proper verification and properly stored and maintained. Any such product that is lost damaged or is otherwise unsuitable for use shall be recorded and reported to the Customer by customer representative & IN CHARGE Marketing.

It shall be the responsibility of QA personnel to verify the quality of such product even if it has been supplied by the Customer

8.5.4 Preservation

Xxx preserves the outputs during production and service provision, to the extent necessary to ensure conformity to requirements. Preservation includes identification, handling, contamination control, packaging, storage, transmission or transportation, and protection. At all stages of production, appropriate material/product handling, storage, packing of products, preservation, and delivery of products established viz. The material in storage – is preserved by packing in Gunny bags. In-process – the material is stored in Bins and Air Bubble bags. Finished goods – All parts are surface coated & packed in BINS with Plastic coverage.

Storage and Inventory

A suitable inventory control system is established to optimize inventory turns, assure stock rotation & minimize inventory levels. Stores Section shall monitor stock levels and inform the purchase section in time & FIFO is emphasized.

 Handling and Storage of Incoming Material

At present manual methods are provided for the movement of brought-out items and raw material respectively. In charge, Stores shall ensure safe handling of materials/items received in stores.

Secured storage space with proper environmental conditions to protect the products stored shall be provided for all items in stores. Shelf-life items are identified and periodic inspection of all stored items is conducted once in three months for fitness for use.

Store In-charge has the defined responsibility to receive issue & dispatch materials from secured storages i.e., Stores & Finished Goods Stock point.

All material in stock is periodically assessed to verify continued fitness for use. The proper material accounting shall be maintained in the stock ledger, with the consideration for keeping stored items in usable conditions.

 In process Products

Handling of In-process material is done using Trollies and BINS. At all times the individual operator ensures safe handling of the material to prevent damage. Storage on the shop floor, for in-process products, if required suitable packaging material will be used to protect the products from any kind of damages, deterioration due to environmental conditions.

Finished Products

Finished products are handled carefully with the use of hydraulic Trollies and packed by using BINS and Polythene bags, so as to protect them from any kind of damage and kept in Finished goods area is the duly cleaned condition. All finished products stored will be under the control of the assembly in charge.

 Packaging

The packaging of products carried out according to packaging instructions/drawings wherever applicable, i.e., contractually agreed or if product nature calls for packing. Type of packaging material & its quality is ensured as per customer requirements if mentioned in the purchase order. Material/packages used for the packing of products are verified before packing to ensure its conformance to specified requirements as per Purchase Order/ Customer Requirement. The packing method employed will be adequate to protect the products fully till they reach their destination if contractually specified.

8.5.5 Post-delivery activities

Xxx is meet requirements for post-delivery activities associated with the products and services

Xxx  considers In determining the extent of post-delivery activities that are required,

1. statutory and regulatory requirements
2. the potential undesired consequences associated with its products and services
3. nature, use and intended lifetime of its products and services
4. customer requirements
5. customer feedback

Delivery

The product quality is protected after final inspection & testing and wherever contractually specified extended from delivery to destination. The deliveries of products are done as per contract terms/delivery schedules for the customer.

8.5.6 Control of changes

Xxx reviews and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. Xxx is to 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.

8.6 Release of products and services

Xxx implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met. The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.

Xxx is retain documented information on the release of products and services. The documented information includes

1. Evidence of conformity with the acceptance criteria
2. Traceability to the person(s) authorizing the release

To ensure that the products manufactured meet the quality requirements of customer fully, a systematic approach for inspection and testing at all stage viz. incoming, in the process and final are demonstrated. At each stage, the activity is performed according to documented procedures.

Receiving Inspection & Testing

Inspection / Verification of incoming material is carried out according to the respective Incoming Inspection Standards & Control plans. This is the responsibility of IN CHARGE QA. The control plan for incoming shall use one of the following methods –

• Inspection and/or testing on sampling method.
• Inspection at suppliers premises with/without system audit.
• Quality assurance certificate or the test report from the supplier.

The incoming materials used in production shall not be used or processed without acceptance by Receipt inspection. Store Personnel are responsible for receipt, identification, records and storage of all Incoming materials, the detailed procedure for incoming material inspection is described.

In-process Inspection & Testing

All in-process inspections carried out according to the applicable control plans by QA during in process based on sample inspection and as per the documented procedures for the required tests. The details of in-process inspection are described in the respective process owner’s procedure   Inspection and Tests Records

Records of inspection/tests at all stages mentioned above are prepared in specific forms & maintained. The format-number(s) of records as mentioned in respective procedures/work instructions /control plans. IN CHARGE QA & IN CHARGE PRD will be the approving authority at each stage for the disposition of non-conforming materials/products. The system of handling of non-conforming materials/products is described in  

8.7 Control of nonconforming outputs

Procedures are established for identifying non-conforming product at Stores and stages of production/inspection as well as at the final inspection stage. The non-conforming materials are identified by the production operator/ QA Personnel at these stages and suitably identified. Responsibility and authority are assigned for segregation, review and disposition of non-conforming product. Documented information of segregation, review and suitable disposition of non-conforming materials are maintained by QA Personnel. Who is authorized to review the non-conforming product?

The decisions of review as per application for disposition may be

• The action which has to be taken to eliminate the non-conforming situation.
• Use as it is under concessions (deviation) / with partial rework or without rework after approval from defined Authorization.
• Rework to meet specifications.
• Reject / scrap.
• Return to the supplier.
• Regard for alternative applications.
• Reworked / Repaired product re-verified to demonstrate conformity to the requirement in accordance with the documented control plan. Details for the handling of nonconforming outputs are described in Procedure

9 Performance evaluations

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

Xxx is evaluating the performance and the effectiveness of the quality management system. Xxx is retaining appropriate documented information as evidence of the results.

Purpose:  To establish measurement, analysis and improvement plan for all the process / Function defined in the Quality Management System.

Objective: To establish quality management measurement process and monitor as per planned results for achievement also establish processes to identify non-conformity situation and subsequently corrective & preventive actions to be taken. IN CHARGE QA in consultation with all respective production process heads plan and implement the monitoring, measurement, analysis, and improvement processes needed.

1. What needs to be monitored and measured
2. The methods for monitoring, measurement, analysis and evaluation needed to ensure valid results
3. When the monitoring and measuring shall be performed
4. When the results from monitoring and measurement are analysed and evaluated

9.1.2 Customer satisfaction

Xxx is to monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. Xxx is determined the methods for obtaining, monitoring, and reviewing this information. The MKT In Charge has primary responsibility for Customer Satisfaction as one of the measurements of the Quality Management System and as to whether the organization has met customer requirements. Customer satisfaction shall include the collection of authentic data, frequency, and validity of the analysis. The trend and major elements affecting customer satisfaction and key indicators of customer dissatisfaction will be monitored supported by objective evidence. Wherever data available, the level of customer satisfaction will be compared with those of our competitors & a relevant action plan will be evolved. A customer satisfaction analysis survey will be conducted ONCE IN A 12 MONTHS Review of customer satisfaction will be taken by top management during Management Review Meeting as described in Procedure.

9.1.3 Analysis and evaluation

Xxx is analyzed and evaluates appropriate data and information arising from monitoring and measurement. The results of the analysis are used to evaluate

1. Conformity of products and services
2. The degree of customer satisfaction;
3. The performance and effectiveness of the quality management system;
4. If planning has been implemented effectively;
5. The effectiveness of actions taken to address risks and opportunities;
6. The performance of external providers;
7.  The need for improvements to the quality management system

9.2 Internal audit

Procedures are established for a system of planned and documented internal quality audits to verify that the Quality Management System conforms to the planned arrangements as per           ISO 9001:2015 requirements and effectively implemented and maintained.

The MR is responsible for:

• Planning and organizing audits at works depending on the importance and the extent of the activity concerned and the results of the previous audits. The internal quality system audits as per schedule are to be carried out at least once in SIX Months period and at least 02 times during a year.
• MR also ensures that the trained auditors are involved in quality system audit to ensure the objectivity of the auditing processes and are not directly responsible for the area under audit. The results of the audit are documented in the specified format to record non-conformances in product/process and work practices and brought to the notice of the person responsible for the area audited, who in turn shall take appropriate corrective actions within the agreed time limit and ensure removal of deficiencies observed. Follow up on the effectiveness of the corrective action taken.
• The effectiveness of identified corrective action against any such internal audit findings is verified by the MR prior to subsequent management review meetings and recorded.
• MR is responsible for ensuring that non-conformances observed during IA are closed by appropriate corrective action implementation in a defined period.MR identifies and marks the corrective actions needing confirmation for their effective implementation and also arranges for the verification in subsequent audits or follow-up audits will be planned.
• MR maintains appropriate records of implementation & effectiveness in the form of internal audit reports. The details of the audit team, schedule, preparation of non-conformances reports,
• The follow up on the corrective actions is detailed in the procedure for corrective action
• The nonconformance identified during third-party audits or by external agencies is handled in the same manner. The non-conformances of IA remaining open due to a delay in the implementation of corrective action along with major non-conformances recorded will be reviewed during management review meetings.

9.3 Management review

9.3.1 General

Top management of Xxx is reviewing the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization. Management review will be conducted and chaired by MD  once in SIX Months to ensure continuing suitability & effectiveness in satisfying the requirements of   ISO 9001:2015 and the stated quality policy and objectives.

The Management Review will include all elements of the entire quality system as detailed in the procedure and schedule for the Management Review. Records of Management Review Meetings shall be maintained by MR. The Director during review shall assess opportunities for improvement and the need for changes in the Quality Management System, including the Quality Policy and Quality Objectives.

 9.3.2 Management review inputs

The management review is planned and carried out taking into consideration

1. The status of actions from previous management reviews
2. Changes in external and internal issues that are relevant to the quality management system;
3. Information on the performance and effectiveness of the quality management system, including trends in:
   • customer satisfaction and feedback from relevant interested parties;
   • the extent to which quality objectives have been met;
   • process performance and conformity of products and services;
   • nonconformities and corrective actions;
   • monitoring and measurement results;
   • audit results;
   • the performance of external providers
4. The adequacy of resources;
5. The effectiveness of actions taken to address risks and opportunities;
6. Opportunities for improvement

9.3.3 Management review outputs

The outputs of the management review shall include decisions and actions related to:

1. Opportunities for improvement;
2. Any need for changes to the quality management system;
3. Resource needs.

The Xxx is retain documented information as evidence of the results of management reviews

10 Improvement

10.1 General

Xxx determines and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. These include

1. Improving products and services to meet requirements as well as to address future needs and expectations.
2. Correcting, preventing or reducing undesired effects;
3. Improving the performance and effectiveness of the quality management system.

Improvement is included correction, corrective action, continual improvement, breakthrough change,  innovation, and re-organization.

10.2 Nonconformity and corrective action

10.2.1 When nonconformity occurs, including any arising from complaints, Xxx is

• All nonconformities relating to product, process and quality system are investigated & the results are recorded. While investigating the causes of non-conformances & deciding corrective actions, the team identifies other products/situations where same or similar nonconformance can occur.
• Corrective actions for nonconforming products and processes, detected in the organization are recorded; analyzed, reviewed and necessary actions are taken. This will be the responsibility of IN CHARGE QA & PRD (respective production process In-charge) the corrective action and preventive measures are implemented and their effectiveness is monitored.

The details are as described in the procedure. Corrective actions are taken on customer complaints; by analyzing the causes of the complaints and taking suitable action to prevent their reoccurrence. The effectiveness of the identified corrective action is monitored through customer feedback and also the customers are kept aware of the corrective actions initiated, with each identified corrective action.

10.2.2 XXX retain documented information as evidence of:

a) the nature of the nonconformities and any subsequent action taken
b) the results of any corrective action.

10.3 Continual improvement

Xxx continually improved the suitability, adequacy, and effectiveness of the quality management system. Xxx considers the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of the continual improvement

Process Sequence & Interaction

…………………………………………………. End of Example ……………………. 

10.1 General

The Requirement

The organization must determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. These actions must include improving products and services to meet requirements, as well as, address future needs and expectations; correcting, preventing, or reducing undesired effects; improving the performance and effectiveness of the quality management system. Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation, and reorganization.

Checklist Questions

1. How does the organization determine and select opportunities for improvement?
2. What necessary actions have been implemented to met customer requirements and enhanced customer satisfaction?
3. Show how has the organization Improved processes to prevent nonconformities;
4. Show how has the organization Improved products and services to meet known and predicted requirements;
5. Show how the organization Improved QMS results.

Implementation Guidelines

1. Process improvement, product improvement, and management practices improvement must work together towards improving the organization as a whole, working towards a common aim.
2. Based on the results of the management review, the organization must make decisions and take actions that will drive it towards continual improvement. Those actions can be in the form of corrective actions, training, reorganization, innovation, and so on.
3. There is now a requirement for organizations to focus clearly on customer satisfaction and customer needs by improving:
   a) products and services, now and for the future;
   b) fixing and controlling business issues to reduce things going wrong and improving the QMS
4. Improvement can be effected reactively (e.g. corrective action), incrementally (e.g. continual improvement), by step change (e.g. breakthrough), creatively (e.g. innovation) or by re-organization (e.g. transformation).

10.2 Nonconformity and Corrective Action

The Requirement

10.2.1

When a nonconformity occurs, including any arising from complaints, the organization must react to the nonconformity and, as applicable take action to control and correct it; and deal with the consequences. The organization must also evaluate the need for action to eliminate the causes of the nonconformity so it does not recur or occur elsewhere, by reviewing and analyzing the nonconformity,  determining the causes of the nonconformity, and determining if similar nonconformities exist, or could potentially occur. The organization must implement any action needed and review the effectiveness of any corrective action taken; It must update risks and opportunities determined during planning, if necessary and make changes to the quality management system, if necessary. The corrective actions must be appropriate to the effects of the nonconformities encountered.

10.2.2

The organization must “retain” documented information as evidence of the  nature of the nonconformities and any subsequent actions taken and  results of any corrective action.

Checklist Questions

1. When any nonconformity (including complaints) occurs, how 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 non-conformity?
3. How does the organization reviews and analyzes the nonconformity?
4. How does the organization determine the causes of the nonconformity?
5. How does the organization determine similar nonconformity exist or could potentially occur?
6. How does the organization implemented any action needed?
7. How does the organization reviewed the effectiveness of the corrective action taken?
8. How does the organization updated risk and opportunities determined during planning if necessary?
9. Has the organization made changes to the QMS if necessary?
10. Show how correction actions were appropriate to the effects of the nonconformities encountered.
11. What documented information can you show as evidence for the nature of the nonconformities and subsequent actions taken and the results of any corrective action.

Implementation Guidelines

1. Corrective action is the action taken to eliminate the cause of a detected nonconformity to prevent a recurrence, whereas preventive action is the action taken to eliminate the cause of a potential nonconformity or other undesirable situation, to prevent occurrence.
2. Corrective action can reduce the likelihood of recurrence to an acceptable level.
3. In some instances, it can be impossible to eliminate the cause of nonconformity.
4. Your corrective action process must address the following control requirements:
   a) Identify detected nonconformities that relate to your products, QMS processes, resources, suppliers and outsourced work, product shipped to customers, customer complaints, cost of quality reports, and things went wrong reports.
   b) Define your process for identifying nonconformities and consider using appropriate problem-solving tools to determine the underlying root cause(s) of the nonconformity
   c)Problem-solving tools may include analysis of failure mode, capability studies, correlation diagrams, data collection, fishbone diagram (Ishikawa diagram), histograms, Pareto analysis, probability charts, stratification of data, graphic representations, etc. Ensure that personnel applying these tools are competent and trained.
5. Actions taken to eliminate the cause of nonconformity must flow from your problem-solving activity. Actions may involve changes to product, process, resources, documentation, controls, etc. or any combination of these. Conduct follow-up tests to determine whether these actions have indeed eliminated the cause(s) of the nonconformity and prevented recurrence.
6. Evaluate the significance of nonconformities in terms of their impact on operating costs, cost of nonconformity and its correction, product performance, safety, dependability, regulatory requirements, the effect on customer’s products and processes, any other risks, and customer satisfaction.
7. You must update risks and opportunities. Keep records of all non-conformities, what you did to resolve them, implement additional measures, follow-up action, etc
8. You must monitor your corrective action records on an ongoing basis, for any recurrence of the nonconformity you took corrective action on. If you found that the problem has occurred again, then perhaps your analysis of the root cause may have been incorrect or incomplete. Keep appropriate records of all corrective action steps.

10.3 Continual Improvement

The Requirement

The organization must continually improve the suitability, adequacy, and effectiveness of the quality management system. The organization must consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that must be addressed as part of continual improvement.

Checklist Questions

1. Demonstrate that you continually improve the suitability, adequacy, and effectiveness of the QMS.
2. Demonstrate that outputs of analysis and evaluation and the outputs from management review are considered to confirm if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement.
3. What applicable tools and methodologies for the investigation of the causes of underperformance and to support continual improvement are selected?

Implementation Guidelines

1. The continual improvement process can be conducted by small-step ongoing improvement activities conducted by personnel within existing processes (Kaizen Events).
2. Useful tools that are often used to continually improve, include capability studies, design of experiments, risk analysis, SPC, supplier evaluation, test and measurement technology, the theory of constraints, overall equipment effectiveness, technology, benchmarking, analysis of motion/ergonomics, and error-proofing. Ensure that personnel applying these tools are competent and trained.

Documented Information if applicable

1. NCR status Log
2. Non Conformance Report

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9.1 Monitoring, measurement, analysis, and evaluation

9.1.1 General

The Requirement

The organization should determine what needs to be monitored and measured. It must also determine the methods for monitoring, measurement, analysis, and evaluation needed to ensure valid results. When the monitoring and measuring must be performed. Also when the results from monitoring and measurement must be analyzed and evaluated. The organization should also evaluate the performance and effectiveness of the quality management system. It must retain appropriate documented information as evidence of the results.

Checklist Questions

1. Show how does the organization determines what needs to be monitored and measured?
2. Show how does the organization determines what methods for monitoring, measurement, analysis, and evaluation to ensure valid results?
3. Show how does the organization determines what to perform monitoring and measuring?
4. Show how does the organization determines what results shall be analyzed and evaluated?
5. What documented information can you show that monitoring and measurement activities have been implemented in accordance with determining requirements?
6. Show how the organization evaluates the quality performance and the effectiveness of the QMS.

Implementation Guidelines

1. The organization must plan and implement processes that monitor, measure, analyze and evaluate the health of your QMS. The focus of these processes must be on product/service conformity, process conformity, and improving QMS effectiveness.
2. You must monitor your processes:
   a) First to determine and establish the capability of new processes to conform to requirements.
   b) And secondly, to monitor these processes over time to verify ongoing stability and capability to meet requirements.
   c) And thirdly to determine and achieve levels of continual improvement
3. The monitoring and measurement techniques, sampling plans, acceptance criteria should be documented or referenced in your quality plan, or you could use a combination of specific practices, procedures, documents and methods.

 9.1.2  Customer Satisfaction

The Requirement

The organization should monitor customer perceptions of the degree to which their needs and expectations have been fulfilled and must determine the methods for obtaining, monitoring, and using this information. Some of the methods by which monitoring of customer perceptions can include customer surveys, customer feedback on delivered products or services, meetings with customers, market-share analysis, compliments, warranty claims, and dealer reports.

Checklist Questions

1. How does the organization monitor customer perception of the degree to which requirements have been met?
2. How does the organization obtain information relating to customer views and opinions of products and services?
3. What are the methods for obtaining and using this information?

Implementation Guidelines

1. Information related to customer views can include customer satisfaction or opinion surveys, customer data on delivered products or services quality, market share analysis, compliments, warranty claims, and dealer reports.
2. Customer requirements may relate to the design, manufacture, delivery, servicing, and support of the product, QMS, communication, and financial requirements, etc.
3. The organization should consider both external as well as internal customer satisfaction. The organization must monitor trends in customer satisfaction indicators and use these as a baseline for continual improvement.

9.1.3 Analysis and Evaluation

The Requirement

The organization should analyze and evaluate appropriate data and information arising from monitoring and measurement. Use the results of the analysis to evaluate the conformity of products and services, the degree of customer satisfaction, the performance and effectiveness of the quality management system. The organization must also evaluate if planning has been effectively implemented and the effectiveness of actions taken to address risks and opportunities. The performance of external providers and the need for improvements within the quality management system must also be evaluated. Methods to analyze data can include statistical techniques.

Checklist Questions

1. Show how does the organization analyze and evaluates data and information arising from monitoring, measurement, and other sources.
2. Show how the output of analysis and evaluation is used to:
   a) Demonstrate conformity of products and services to requirements?
   b) Assess and enhance customer satisfaction?
   c) Ensure conformity and effectiveness of the QMS?
   d) Demonstrate that planning has been successfully implemented?
   e) Assess process performance?
   f) Assess the performance of external providers?
   g) Determine the need or opportunities for improvements within the QMS?
3. Show me where the results of analysis and evaluation are used to provide inputs to management review.

Implementation Guidelines

1. You must collect and analyze QMS data that relate to the performance, effectiveness, and efficiency of products, services, QMS processes, production output, external provider (supplier) performance, use of resources, cost of poor quality, customer satisfaction, etc.
2. You must sort and summarize the data you collect into things gone right and things that have gone wrong and present them separately. Management can then focus on continual improvement of things gone right and take corrective action on things gone wrong.
3. A summary of QMS performance data must be included in your periodic management review.

9.2 Internal Audit

The Requirement

9.2.1

The organization should conduct internal audits at planned intervals to provide information on whether the quality management system conforms to the organization’s own requirements, the requirement of ISO 9001:2015 standards and is effectively implemented and maintained

9.2.2

The organization must plan, establish, implement, and maintain an audit program, which must include frequency, methods, and responsibilities, planning requirements, and reporting. While making an audit program, consideration must be given to the importance of concerned processes, changes impacting the organization, and the results of previous audits. It must define audit criteria and scope for each audit. It must select auditors and conduct audits for the impartial and objective audit process. It must ensure the results of audits are reported to relevant management. it must take necessary correction and corrective actions without undue delay. It must retain evidence of audit program implementation and audit results.

Checklist Questions

1. Are internal audits being conducted at planned intervals? Do they determine whether the QMS conforms to the requirements of ISO 9001 and to the other requirements established by Organization? (Review records to demonstrate conformance)
2. Do they determine whether the QMS is effectively implemented and maintained? (Review records)
3. Can you show audit programme(s) that takes into consideration the quality objectives, importance of the processes, customer feedback, changes impacting the organization, and the results of previous audits?
4. What are the audit criteria and scope for the audit?
5. Can you demonstrate that selection of auditors and the conduct of audits are objective and impartial and that auditors don’t audit their own work?
6. How are audit results reported to relevant management?
7. Can you demonstrate that necessary correction and corrective actions are taken without undue delay?
8. Can you show documented information about the audit program and the audit results?

Implementation Guidelines

1. The audit process must address the responsibilities for conducting the audits, ensuring independence, recording results, and reporting to management.
2. Audits obtain objective evidence of conformity with requirements. The evidence must be based on fact and may be obtained through observation, measurement, test, or by other means. Evaluating the extent to which audit criteria are fulfilled involves an assessment of both implementation and effectiveness.
3. The scope of your internal audit program must cover the
   a) Audit of operation processes to determine conformity of product/services and their processes to customer and applicable regulatory requirements.
   b) Audit of the QMS to determine conformity to the ISO 9001 standard and organizational requirements.
   c) Audit of QMS processes and their interaction to determine if the QMS has been effectively implemented and maintained
4. In determining the time frame for your audit program, you should consider organization size, the complexity of product and processes, the health of the QMS, customer, registrar, and regulatory requirements, etc. The most common time frame is six months.
5. Consider adjusting the audit frequency and perhaps even the audit scope, of specific processes or group of processes, when:
   a) You experience internal or external nonconformities.
   b) Get customer complaints.
   c) Have critical or high-risk processes.
   d) Have frequent or significant changes to processes and products.
6. During the audit, auditors should ensure that the objectivity and impartiality of the audit are not compromised. Auditors cannot audit their own work.

9.3 Management Review

The Requirement

9.3.1 General 

The Top Management of the organization should review the Organization’s QMS at planned intervals to ensure its continuing suitability, adequacy,  effectiveness and it should be aligned with the strategic direction of the organization.

9.3.2 Management review inputs

Plan and carry out management review considering the status of actions from previous management reviews, changes in external and internal issues relevant to QMS, the adequacy of resources, opportunities for improvement, and the effectiveness of actions taken to address risks and opportunities as explained in clause 6.1. The organization must also consider information on quality performance and effectiveness, including trends in non-conformities and corrective actions, customer satisfaction and feedback from relevant interested parties, Monitoring and measurement results, Audit results, the extent to which quality objectives have been met, process performance, conformity of product and services, the performance of  external providers 

9.3.3 Management review outputs

Outputs from the management review must include decisions and actions related to opportunities for improvement, any need for changes to QMS, and resource needs. The organization should retain documented information as evidence of the results of management reviews.

Checklist Questions

1. What is the frequency that top management reviews the organization’s QMS? How is the QMS deemed suitable, adequate, and effective?
2. What kinds of information are reviewed in management reviews? Do they include:
   a)     actions status of previous reviews;
   b)     changes to internal/external issues relevant to the QMS;
   c)     issues that affect strategy;
   d)     KPIs for nonconformities and corrective actions;
   e)     monitor and measurement of results;
   f)      audit results;
   g)     customer satisfaction;
   h)     issues concerning external providers;
   i)      issues concerning other relevant parties;
   j)      adequacy of resources and effectiveness of QMS;
   k)     process performance;
   l)      conformity of products and services;
   m)   actions are taken to address risks and opportunities and their effectiveness;
   n)     new potential opportunities for continual improvement.
3. Show that management reviews include decisions and actions relating to:
   a)     Continual improvement opportunities;
   b)     The need for changes to the QMS including resource needs.
4. Show what documented information you have as evidence of management reviews.

Implementation Guidelines

1. Though not required by the standard, there should be a procedure for management review as it has specific requirements for management review inputs, value-adding review activities, and outputs. The procedure should address the frequency, schedule, quorum, and agenda for review meetings to be attended by top management.
2. For the management review process itself to be effective, top management must plan the review of all agenda items with some regularity and take timely action to change or improve any part of it, including the quality policy and objectives.
3. The Top Management can incorporate QMS agenda items into regular monthly or quarterly operational meetings.
4. Management review input should preferably be in summary form, showing QMS and operational performance measured against the business and quality plans, customer and regulatory objectives, and goals.
5. Review decisions and actions must relate to improving products and processes or even creating new ones, providing more resources or perhaps improving the efficiency of existing resources, improving QMS controls, objectives, improving overall QMS effectiveness and customer satisfaction.
6. Responsibilities and timelines should accompany these decisions and actions.
7. The performance of these actions must be followed up at subsequent management review meetings.
8. You must also identify what specific documents are needed for effective planning, operation, and control of this process. These documents may include – a documented information, review on, schedule, agenda, and action forms, etc., combined with unwritten practices, procedures, and methods.
9. Management review records must include topics discussed, decisions, responsibilities for corrective or improvement actions and related timelines, provision of resources, and follow-up actions from previous management reviews.

Documented Information if applicable

1. Problem Analysis Report
2. Customer Satisfaction Survey Form
3. Customer Complaint Register
4. Annual Internal Audit Plan
5. Internal Audit Schedule
6. Internal audit report
7. List of internal auditor
8. Management Review Meeting record

8.1 Operational Planning and Control

The Requirement

The Organization should plan, implement, and control the processes, as outlined in 4.4, needed to meet requirements for the provision of products and services and to implement the actions determined in 6.1 by determining product and services requirements; establishing criteria for the processes and for the acceptance of products and services; determining the resources needed to achieve conformity to product and service requirements; implement control of the processes in accordance with the criteria; determining, maintaining and retain documented information to the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate the conformity of products and services to requirements. The output of this planning should be suitable for the organization’s operations. The organization should control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. The organization should ensure outsourced processes are controlled in accordance with 8.4.

Checklist Questions

1. How are processes needed to meet requirements for the provision of products and services planned, implemented, and controlled?
2. How are requirements for products and services determined?
3. How are the criteria for processes and acceptance for products and services determined?
4. How are resources determined?
5. How is process control implemented?
6. Show the documented information that shows confidence in that the processes have been carried out as planned and can demonstrate the conformity of products and services.
7. How the organization does determine that the output from the planning process is suitable for its operations?
8. How does the organization control planned changes? How are the consequences of unintended changes reviewed? What action is taken to mitigate any adverse effects?
9. How are outsourced processes controlled?

Implementation Guidelines

1. The focus of clause 8.1 is on controls governing the making of products to meet customer requirements and all the QMS processes that, directly or indirectly, make this happen. Operation processes may include customer-related processes (sales and marketing), design and development, production, shipping, receiving, packaging, measurement, and monitoring of product and processes, etc., whether performed onsite or off-site.
2. The output of Operation planning may be implemented in many different ways such as product /project quality plan, drawings, machine set-up, inspection criteria, process sheets, etc. These must be readily available to those performing these processes.
3. Quality plans should include the processes needed, process sequence and control parameters, specific resources needed to make, verify and deliver the product, product acceptance criteria and quality objectives, product, and process monitoring, and measurement control plans to control and correct any product or process nonconformities, reference to support processes, documents needed such as work instructions or engineering specifications, etc. and details of records to be kept.
4. You must also identify what specific documents are needed for effective planning, operation, and control of production processes. These documents may include contracts, specifications, orders, product quality plans, work instructions, a documented procedure, etc., combined with unwritten practices, procedures, and methods.
5. Quality objectives may include defect rates, scrap rates, etc. Requirements or criteria for the product may include physical properties, dimensional, functional, etc, and their related measurements, tolerances, and acceptance levels. In many instances, depending on the nature of the product, the customer may specify objectives and requirements, and criteria for the product realization processes as well.
6. Steps to Operation planning may include a)    Create a quality plan for a product or service to describe how the QMS will be modified and applied to all operations. Such a plan could include or reference procedures and records to be maintained and analyzed. b)    Consider using the product design and development process approach for designing processes. This is a requirement in the automotive industry. It has become a best practice demonstrated in many organizations even though ISO 9001 does not explicitly require adherence to the design and development requirements for internal process designs. This enhances both the effectiveness and the efficiency of processes. c)    Identify key performance measures for both products and processes and align them with your quality and business objectives.

8.2 Determination of Requirements for Products  and Services

The Requirement

8.2.1 Customer Communication

The organization must establish the processes for communicating with customers to provide information relating to products and services; inquiries, contracts, or order handling, including changes;  obtaining customer feedback relating to product and services including customer complaints; handling or controlling customer property, and establishing specific requirements for contingency actions, when relevant.

8.2.2 Determination of Requirements related to Products and Services

The organization must ensure while determining the requirements for the products and services to be offered to customers that the product and service requirements (including those considered necessary by the organization), and applicable legal requirements, are defined. The organization must also ensure that it has the ability to meet the defined requirements and substantiate the claims for the products and services it offers.

8.2.3 Review of Requirements for Product and services

8.2.3.1 The organization must ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to a customer. The review should include the requirements specified by the customer, including the requirements for delivery and post-delivery activities; requirements not stated by the customer, but necessary for the specified or intended use, when known, requirements specified by the organization, statutory and regulatory requirements applicable to the products and services, contract or order requirements differing from those previously expressed. The organization must ensure that contract or order requirements differing from those previously defined are resolved.  When the customer does not provide a documented statement of their requirements, the organization must confirm them before accepting them.  In some situations, such as internet sales, when a formal review is impractical for each order, the review can cover relevant product information, such as catalogs.

8.2.3.2 The organization should 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

The organization should ensure that relevant documented information is amended, and those relevant persons are made aware of the changed requirements. when the requirements for products and services are changed.

Checklist Questions

1. What are the processes for communicating with customers? How does the organization communicate information relating to Products, Services, Enquiries, Contracts, Order handling, Customer views, perceptions and complaints, Handling or treatment of customer property, Specific requirements for contingency actions?
2. What is the process to determine the requirements for products and services to be offered to potential customers? How this process is established, implemented, and maintained?
3. How does the organization define product and service requirements including statutory and regulatory requirements?
4. How do you ensure that you have the ability to meet the defined requirements and substantiate any claims for your products and services?
5. How the organization does review customer requirements for delivery and post-delivery?
6. How the organization does review requirements necessary for customers’ specified or intended use, where known?
7. How the organization does review additional statutory and regulatory requirements applicable to products and services?
8. How the organization does review any other contract or order requirements?
9. Show that the review is conducted prior to your commitment to supply products and services to your customers. How do you resolve contract or order requirements which differ from those previously defined?
10. How does the organization confirm customer requirements where the customer does not provide a documented statement?
11. What documented information is retained which describes the results of the review including any new or changed requirements?
12. Show the documented information containing changes to products and services. How do you ensure that relevant personnel is made aware of those changes?

Implementation Guidelines

1. This Customer’s communication must include information related to the products or services, handling inquiries, contracts or orders, customer feedback, handling and controlling customer property, and, if needed, establishing specific requirements for contingency actions. Ensure that the customer has a clear written quotation and specification relating to the product/ services they want. Communication with customers needs to ensure is that customer requirements and other requirements for the product or service are clearly understood.
2. To avoid customer complaints or dissatisfaction, even for “requirements” that are not clearly stated (e.g., regulatory requirements or marketplace norms), the organization should consider a comprehensive understanding of customer requirements, perhaps even performing Risk assessment on the processes.
3. Clause 8.2.2 requires the organization to determine the requirements related to its products and services. This includes a) Establishing a process for determining the requirements for the products offered to potential customers. b) Determining requirements of the customer, For the organization, and from applicable statutes and regulations. c)Determining that the organization has the ability to meet the requirements and substantiate claims related to its products and services
4. It is recommended that you maintain documented information to describe the process for the determination of all aspects of product and service requirements. The documented information should include both product requirements specified by the customer and product requirements not specified by the customer but necessary for intended or specified use. Also, unique regulatory and statutory requirements should be considered as well as commercial terms and conditions.
5. The organization must review the requirements of products and services, which include:         a) Customer-specific requirements for the product or service, including any requirements for delivery or post-delivery actions. b) Requirements are known to be needed by the organization even though not specified by the customer. c) Applicable statutory and regulatory requirements applying to the product or serviced) Requirements of the final contract or order differing from those previously provided by or discussed with the customer
6. Changes are required to be controlled and documented information updated to ensure that changes are properly included in documented information. When changes to product requirements, orders, contracts, or quotations occur, the organization is required to ensure that relevant documented information is amended and communicated, as appropriate, within the organization.

 8.3 Design and Development of Products and Services

The Requirement

8.3.1 General

The organization should establish, implement, and maintain a design and development process. such that they are adequate for subsequent production or service provision.

8.3.2 Design and Development Planning

While planning for design and development, the organization must consider the following  in determining the stages and controls for design and development:

1. nature, duration, and complexity of the design and development activities;
2. the required process stages, including applicable design and development reviews;
3. the required design and development verification and validation activities; 
4. the responsibilities and authorities involved in the design and development process;
5. the internal and external resource needs for the design and development of products and services;
6. the need to control interfaces between persons involved in the design and development process;
7. the need for involvement of customers and users in the design and development process;
8. the requirements for the subsequent provision of products and services; 
9. the level of control expected for the design and development process by customers and other relevant interested parties;
10. the documented information needed to demonstrate that design and development requirements have been met

8.3.3 Design and Development Inputs

The organization must determine the requirements essential for the specific type of products and services being designed and developed, including, as applicable, functional and performance requirements; applicable legal requirements; information derived from previous similar design and development activities;  standards or codes of practice the organization has committed to implement;  potential consequences of failure due to the nature of products and services;  Ensure inputs are adequate for design and development purpose, complete, and unambiguous. Resolve conflicts among Design and Development inputs.

8.3.4 Design and Development Controls

The organization should apply controls to the design and development process to ensure that results to be achieved by the design and development activities are clearly defined; Design and development reviews are conducted as planned; Verification activities are conducted to ensure that the design and development outputs have met the design and development input requirements; Validation activities are conducted to ensure that the resulting products and services are capable of meeting the requirements for the specified application or intended use (when known). The organization must take any necessary actions on the problems determined during the reviews, or verification and validation activities. The organization must maintain any documented information of these activities. Design and development reviews, verification, and validation have distinct purposes. They can be conducted separately or in any combination. as is suitable for the products and services of the organization.

8.3.5 Design and Development Outputs

The organization must ensure that design and development outputs meet the input requirements for design and development. They should be adequate for the subsequent processes for the provision of products and services. They must include or have a reference of monitoring and measuring requirements, and acceptance criteria, as applicable. They must ensure products to be produced, or services to be provided, are fit for the intended purpose and their safe and proper use. The organization must retain the documented information resulting from the design and development process.

8.3.6 Design and Development Changes

The organization should identify, review and control changes made (during the design and development of products and services, or subsequently) to design inputs and design outputs to the extent that there is no adverse impact on conformity to requirements. The organization must retain documented information on design and development changes, the result of the review, the authorization of changes, and action is taken to prevent adverse impact.

Checklist Questions

1. Where detailed requirements of the products and services are not already established or defined by the customer or other parties, how does the organization establish, implement and maintain a design and development process?.
2. When determining the stages and control for design and development, show how does the organization consider: a) The nature, duration, and complexity of the activities;b) Requirements that specify particular process stages including applicable reviews;c) Required verification and validation; d) Responsibilities and authorities;e) How interfaces are controlled between individuals and parties; f) The need for involvement of customer and user groups.
3. Show the documented information that confirms design and development requirements have been met.
4. Can you show me how does the organization determines the requirements essential for the type of products and services being designed and developed, including Functional & performance requirements as applicable?
5. Can you show me how does the organization determine the Statutory & regulatory requirements;
6. Can you show me how does the organization determines the Standards or codes of practice where there is a commitment to implement?
7. Can you show me how does the organization determine the Internal and external resources needed for
8. Can you show me how does the organization determines the design and development of products and services?
9. Can you show me how does the organization determines the Potential consequences of failure?
10. Can you show me how does the organization determines the level of control expected of the design and development process by customers and other relevant parties?
11. How the organization does determine that inputs are adequate, complete, and unambiguous for design and development? How do you resolve conflicts among inputs?
12. How do controls that are applied to the design and development process ensure: a) Results achieved by design and development activities are clearly defined? b) Design and development reviews are conducted as planned? c) Outputs meet the input requirements by verification/ Validation is conducted to ensure that the resulting products and services are capable of meeting the requirements for the specified application or intended use when known?
13. How do you ensure that design and development outputs meet the input requirements for design and development?
14. How do you ensure that design and development outputs are adequate for the subsequent processes for the provision of products and services?
15. How do you ensure that design and development outputs include or reference monitoring and measuring requirements, and acceptance criteria, as applicable?
16. How do you ensure that design and development outputs ensure products to be produced, or services to be provided, are fit for the intended purpose and their safe and proper use?
17. Show me the documented information which results from the design and development process.
18. How do you review, control and identify changes made to the design inputs and outputs during the design and development of products and services ensuring no impact on conformity to requirements?
19.  Show me the documented information for design and development changes.

Implementation Guidelines

1. The scope of your design and development activity must consider all aspects of the product and product realization processes to ensure its conformity to requirements. This includes product identification, handling, packaging, storage, and protection during internal processing and delivery to the customer. This clause is equally applicable for designing and developing manufacturing processes. It is required to include the following: a) Planning to determine design stages considering activities such as verification and validation, control of design interfaces, design review, resources needed for design and development, customer involvement, and the documented information needed to confirm that input requirement are met. b) Determination of the design and development inputs required, including such things as functional requirements, regulatory and statutory requirements, applicable standards or codes, information from earlier projects, and potential consequences of failure. Conflicting requirements are required to be resolved. c) Design and development controls, including clear delineation of the results to be achieved, planning and conducting design and development reviews and verification activities to ensure design outputs meet input requirements, and validation to ensure the products and services meet the requirement for the application intended.d) Design and development outputs are required to meet input requirements, to be adequate for subsequent processes in the provision of the product or service, and to ensure the products and services are fit for their intended purpose. e)Design and development changes are required to be identified, reviewed, and controlled. This includes changes to design inputs or outputs. Controls are required to ensure that changes do not have an impact on the products and service conformity. f)The organization is required to retain documented information resulting from the design and development process, including design and development changes.
2. D& D Requirements need to be established review, verification, and validation into the D & D project. The organization needs to determine how communications will be structured e.g., weekly meetings, periodic reports, or other methods.
3. One must take a multi-disciplinary approach that includes as needed, other functions (besides design) such as quality, engineering, purchasing, sales, tooling, production, etc. Your plan must clearly identify these other functions and their specific role and responsibilities regarding the project. Consider including customer and supplier personnel at appropriate stages to do work and review results or progress
4. D& D plan must specify the D & D stages, activities and tasks, responsibilities, timeline and resources, specific tests, validations, and reviews, and outcomes. There are many tools available for planning ranging from a simple checklist to complex software. The degree and details of planning may vary according to size and length of contract or project, complexity, risk, product life, customer and regulatory requirements, past experience with a similar product, etc.
5. D & D plans must be dynamic and updated as requirements and circumstances change. The organization must track progress against the D & D plan at regular intervals or project milestones and update the plan as the activity progresses. It must include methods to communicate information, responsibilities, results, discussions, reviews, and resources.
6. You must also identify what specific documents are needed for effective planning, operation, and control of production activities These documents may include contracts, technical drawings, and specifications, a documented plan for design and development, work instructions, a documented procedure, etc., combined with unwritten practices, procedures and methods.
7. The design and development project plan serves as both a document and a record as it is updated for completion for various activities.
8. There must be a process that should be part of the D & D plan to identify, document, review, deploy and use design input information such as documents coming from various sources such as customer contracts, drawings, and specifications, organization’s database of previous design and development projects, competitor analysis, industry standards, feedback from suppliers, field data.
9. The organization must identify and include any special and safety characteristics in the process control documents such as quality plans, product drawings, operator instructions, and other documents used to make or verify the product.
10. You must review all input requirements, review design and development progress, verify product design and validate developed products at various stages of your design and development process. The nature, frequency, and scope of these controls must be defined in your design and development plan or other documents. You must carry out these controls according to your plan and keep appropriate records.
11. Do design reviews at one or more milestones of the design and development project, depending on customer requirements, the size, complexity, and risks involved. The purpose of these reviews is to evaluate results to requirements, check project progress and costs to plan and take actions on any problems encountered.
12. There must be a multi-disciplinary approach for doing these reviews and keep appropriate records of issues discussed, actions to be taken, responsibilities, and the timeline for completion. All design and development reviews must be included in your design and development plan.
13. Product design Verification includes design reviews, comparing the new design to a similar proven design if available, performing alternate calculations, performing tests and simulations, reviewing the design documents before release, etc.
14. Manufacturing process design verification includes design review, process capability studies, testing various process parameters, performing tests and trials, reviewing the manufacturing process design documents before release, etc.
15. Verification is checking product or process to input requirements, whereas validation is checking product or process is suitable for its intended use does it perform/function in the way intended by your customer or your organization. Product and manufacturing process validation includes – design reviews, comparison between customer requirements and internal development plans, design and development validation against customer requirements and design and development input requirements, corrective action, and lessons learned from documented process failures and product nonconformities.
16. Any problem you have encountered during the verification and validation of identified during review must be resolved.
17. Design and development output may be product or documentation or both. Product may be a prototype or finished product and documentation could be a computerized or hard copy drawing or specification. Check design and development output against the input requirements, before you use it any further.
18. Many documents are created from the design and development output stage such as drawings, quality plans, work instructions, etc. Where any sophisticated design and development tools such as AutoCAD are used requiring specific competency or training, ensure you provide and keep appropriate records of competency and training of personnel performing design and development activities and use of these tools.
19. Provide appropriate design and development output information to a) Purchasing material or service specifications. b) Production output such as product specifications, special characteristics, drawings, diagnostics, etc. c) Service output such as product specifications; performance reliability, and maintenance criteria.
20. D & D Changes may come from the internal, customer, or regulatory sources. Get all requests for product or manufacturing process design changes in writing from your customer. The impact of the change must be evaluated on materials used, design process, manufacturing process, characteristics and use of the developed product, regulatory compliance, cost, etc.
21. Make sure your process for design and development changes follows appropriate steps ie define the plan, have inputs and outputs, verify and validate to the extent necessary to meet customer requirements, and control product, quality, and business risks.
22. Documented information on design and development changes, the result of the review, the authorization of changes, and action is taken to prevent adverse impact must be maintained.

8.4 Control of Externally Provided Products and Services

The Requirement

8.4.1 General

The organization must ensure that externally provided processes, products, and services conform to specified requirements. The organization must apply the specified requirements for control of externally provided products and services when products and services are provided by external providers for incorporation into the organization’s own products and services; products and services are provided directly to the customer by external providers on behalf of the organization;  a process or part of a process is provided by an external provider as a result of a decision by the organization to outsource a process or function. The organization must determine and apply criteria for evaluation, selection, monitoring of performance, and re-evaluation of external providers based on their ability to provide processes or products and services in accordance with specified requirements. The organization must retain appropriate documented information of the above-mentioned activities and any necessary action arising out of the evaluation.

8.4.2 Type and Extent of Control

The organization should ensure that externally provided processes, products, and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers. The organization should ensure that externally provided processes remain within the control of its quality management system. It should define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output.  In determining the type and extent of controls to be applied to the external provision of processes, products, and services, the organization must consider the potential impact of the externally provided processes, products, and services on the organization’s ability to consistently meet customer and applicable legal requirements and effectiveness of the controls applied by the external provider. The organization must establish and implement verification or other activities necessary to ensure the externally provided processes, products, and services meet the requirements. 

8.4.3 Information on External Providers

The organization must ensure the adequacy of specified requirements prior to their communication to external providers. The organization should communicate to external providers applicable requirements for the following:

1. products and services to be provided or the processes to be performed on behalf of the organization;
2. approval or release of products and services, methods, processes, or equipment;
3. competence of personnel, including necessary qualification;
4. their interactions with the organization’s quality management system;
5. control and monitoring of the external provider’s performance to be applied by the organization;
6. verification activities that the organization, or its customer, intends to perform at the external provider’s premises.

Checklist Questions

1. How does the organization ensure externally provided processes, products and services conform to specified requirements?
2. Show how the organization applies specified requirements for the control of externally provided products and services when: a) Products and services are provided by external providers for incorporation into products and services;b) Products and services directly to customers by external providers on your behalf;c) A process or part-process is provided by an external provider as a result of a decision to outsource a process or function.
3. Show how does the organization establish and applies criteria for evaluation, selection, monitoring of performance, and re-evaluation of external providers. How do you assess their ability to provide processes or products and services in accordance with specified requirements?
4. What documented information is available as results of evaluations, monitoring of performance, and reevaluations of external providers?
5. How does the organization determine the controls applied to the external provision of processes, products, and services and take them into consideration? a) The potential impact of the externally provided processes, products, and services on the ability to consistently meet customer and applicable statutory and regulatory requirements? b) The perceived effectiveness of the controls applied by the external provider?
6. What verification or other activities does the organization have to ensure externally provided processes, products and services do not adversely affect its ability to consistently deliver conforming products and services to customers?
7. When processes or functions have been outsourced to external providers, how do you define the controls intended to be applied to the external provider and to the resulting process output?
8. Show how the organization communicates to external providers, applicable requirements for a) Products and services to be provided or the processes to be performed on behalf of the organization;b) Approval or release of products and services, methods, processes, or equipment;c) Competence of personnel, including necessary qualification; d) Their interactions with the organization’s quality management system;e) The control and monitoring of the external provider’s performance to be applied by the organization;f) Verification activities that the organization, or its customer, intends to perform at the external provider’s premises.
9. Before you communicate with external providers, how do you ensure the adequacy of specified requirements?

Implementation Guidelines

1. Externally provided processes, products, and services include purchasing from a supplier, an arrangement with an associate company, and outsourcing processes to an external provider. The organization can apply risk-based thinking to determine the type and extent of controls appropriate to particular external providers and externally provided processes, products, and services;
2. You must have specifications/criteria for the purchased product. These specifications may come from your organization, customer, regulatory bodies, supplier, or industry. The purchased product may include materials, production equipment, tooling, measuring and test equipment, facilities, transport vehicles, returnable packaging, intellectual property (drawings, specifications, or proprietary information), product returned for servicing under warranty, product sent for outsourced work, etc.
3. Many times the customer may require the use of pre-approved purchased products and suppliers. The onus is still on you to ensure that the purchased product from customer-designated sources meets all requirements.
4. You must control both, the product you buy, as well as the supplier you buy from. Your controls must primarily be based on the prevention of nonconformities in both product and supplier performance.
5. Based on how important the purchased product is to design, manufacture, assemble and maintain your end product, categorize your purchased products and services accordingly. Then determine what controls you need to ensure consistent purchased product quality and consistent supplier performance. You can then apply different controls for different purchased products. These controls must be included or referenced in your quality or inspection plans.
6. There are several ways to evaluate your suppliers. Besides product quality, your criteria for supplier selection and evaluation may include the potential supplier’s financial capability, technical and manufacturing capability, and capacity, reliability, reputation, flexibility to handle changes, support, service, cost, etc.
7. You must maintain a list of all qualified suppliers. In addition to the initial evaluation and approval of suppliers, you are required to carry out ongoing monitoring and measurement of their performance.
8. You must identify your purchasing processes whether on-site or off-site.
9. Use supplier monitoring indicators to evaluate the consistency, capability, and reliability of their performance for quality, On-time delivery, support, etc. On-time delivery is very important and disruptions (due to waiting for materials) at your customers or even your own facility must be avoided.
10. For each process, you must document the controls for purchased products and suppliers. You must also show the linkage and interaction of purchasing processes with other processes such as design, manufacturing, tooling maintenance, calibration.
11. You must keep records of all supplier evaluations (whether initial or periodic), including any corrective actions placed on them for any nonconformities. You must identify and document all processes addressing this clause as part of your QMS. For these processes, you must also identify what specific documents, controls, and resources are needed. You could use a documented procedure or other combination of specific practices, procedures, documents, and methods.
12. Consider using supplier quality plans, inspection plans, etc., to verify that the purchased product meets specified purchase (product and QMS) requirements. Your inspection process must define and document the acceptance criteria and sampling plan for product conformity and what measurement tools needed and records needed to show effective control of purchased product quality and supplier performance.
13. Where any of your controlled suppliers have gone through a significant organizational change you must verify the continuity and effectiveness of their QMS.
14. Your purchase documents such as purchase order, contract, blanket order, your organization’s supplier quality manual, etc. must specify your requirements for the purchased product, the supplier’s QMS, and any other initial or on-going controls you deem necessary for ensuring consistent supplier performance.
15. You must define how you ensure the adequacy of these documents before you communicate them to your supplier. A review of the adequacy of purchasing documents may include their completeness, accuracy, correctness, quantity, timing, cost, approval, etc.,
16. You must show evidence of carrying out (issue purchase documents) and review these documents.
17. An outsourced process is any value-adding or conversion activity related to your product or service, that is performed by an external organization such as a subcontractor, sister facility, etc.
18. You must be able to demonstrate sufficient controls over outsourced processes to ensure that such processes are performed according to the relevant requirements of ISO 9001:20015
19. Outsourced processes may be controlled in any number of ways, e.g., providing the vendor with product specifications, supplier quality manual that they must meet, asking for inspection and test results or certificates of compliance, validation of outsourced process, conducting product and QMS audits of the vendor; etc.

CLAUSE 8.5 Production and Service Provision

8.5.1 Control of Production and Service

The Requirement

The organization should implement production and service provision under controlled conditions. Include these controlled conditions, as applicable:

1. availability of documented information that defines characteristics of products and services.
2. availability of documented information that defines activities to be performed and results to be achieved.
3. availability and use of suitable monitoring and measuring resources
4. implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met.
5. use and control of suitable infrastructure and process environment for operation of the process.
6. appointment of a competent person and, where applicable, required qualification of persons;
7. validation, and periodic revalidation, of ability to achieve planned results of any process for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement.
8. implementation of products and services release, delivery, and post-delivery activities.

Checklist Questions

1. How the organization does implement the production and service provision under controlled conditions?
2. Can you show the availability of any documented information that defines the characteristics of the product, services or activities to be performed and the results to be achieved?
3. Can you show controlled conditions for monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met?
4. Can you show controlled conditions for the use and control of suitable infrastructure and process environment?
5. Can you show controlled conditions for the availability and use of suitable monitoring and measuring resources?
6. Can you show controlled conditions for the competence and, where applicable, required qualification of persons?
7. Can you show controlled conditions for the validation, and periodic revalidation, of the ability to achieve planned results of any process for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement?
8. Can you show controlled conditions for the implementation of products and services release, delivery and post-delivery activities?

Implementation Guidelines

1. To improve your QMS, it will be very useful to draw a flow chart to link the flow and interaction of the activities and sub-processes.
2. Use your product, project, or contract quality plan to control your operational activities. Quality plans address what has to be made, how much has to be made, when it has to be made, by whom, in what sequence, how it has to be made, what equipment to use, what measurement and monitoring tools to use, what to inspect, when to inspect, how much to inspect, what to do if problems arise, etc. Your quality plan must cover all operation process steps from receipt of materials, production, packaging, storage, delivery, and even post-delivery activities such as installation or training.
3. Schedule your operations taking into consideration customer delivery requirements, production capacity and capability, material availability and usage, personnel availability and usage; storage; etc. Carefully define and document the interaction of your operation scheduling process with your logistics processes such as inventory management, customer communication, traffic and shipping control, packaging and labeling, sales, and billing.
4. Your quality plans are dynamic and must be updated for the changes in product specifications or process parameters; resources used; monitoring or measurement requirements, etc. Your quality plans should reference any work instructions specified for the process steps.
5. Work instructions may exist in many forms such as narrative, graphical, audio, video, physical display, etc.If any work instructions are needed at specific points in your process, then they must be readily available and relevant i.e. current or right version.
6. You must also identify what specific documents are needed for effective planning, operation, and control of production activities. These documents may include – a product quality plan; work instructions; documented procedure; etc., combined with unwritten practices, procedures, and methods.
7. Validation is usually required where the product cannot be verified without damaging or destroying the product, e.g. some types of welding, heat treatment, painting, electroplating, rust-proofing, etc. Validation involves conducting capability studies using a combination of resources technology, equipment, materials, environment, competent personnel, and production and testing methods that consistently result in a quality product or service. Validation requires customer or regulatory approval of the process.
8. You must keep appropriate records of process validation showing both the achievement of planned results as well as the ongoing maintenance of such capability. It is up to each organization to determine what combination of resources and methods will provide the required consistent process capability and quality of product or service. Include as appropriate, these validation controls in your quality plans.
9. If you change any part of the proven process capability for e.g. materials, equipment or personnel, etc., you must revalidate i.e re-prove the changed process.

8.5.2 Identification and Traceability

The Requirement

The organization should use suitable means to identify “process outputs” where necessary to ensure conformity of products and services. The organization should identify the status of “process outputs” with respect to monitoring and measurement requirements throughout production and service provision. The organization should control the unique identification of “process outputs” where traceability is a requirement. It should retain any documented information necessary to maintain traceability. “Process outputs” are results of any activities which are ready for delivery to the customer or to an internal customer (e.g., the receiver of inputs to the next process). “Process outputs” can include products, services, intermediate parts, components, etc.

Checklist Questions

1. What suitable means is used by the organization to identify output when it is necessary to ensure the conformity of products and services?
2. How is the status of outputs with respect to monitoring and measuring requirements throughout the production and service provision being identified by the organization?
3. How does the organization control the unique identification of the outputs when traceability is a requirement?
4. Shot the documented information necessary to enable traceability, when traceability is a requirement?

Implementation Guidelines

1. Product status: It means knowing the quality status (good or bad) of materials and products through each of the above stages. Product status can be controlled using physical and electronic methods.
2. Product identification: It means knowing the identity of your or customer-supplied product from incoming receipt of materials, raw material storage, use in production, work in progress, finished product storage, and delivery of the product to the customer. Product identification can be controlled using physical and electronic methods.
3. Unique Product Identification: This usually involves keeping detailed records of product manufacturer such as material, equipment, personnel, processes, production, inspection and test details, etc., for individual products or production batches. These records help to troubleshoot product and process problems, resolve customer complaints, and enable continual improvement of product and process. Depending on the product, the OEM may specify the degree of unique identification and traceability required.
4. Specific Documented information may be included in your Operation processes through your product quality plans, work instructions, and other specific documentation. Examples of product identification and test status include physical tags, barcode labels linked to computer records; MRP systems tracking specific production runs/lots, automated production transfer processes, etc.
5. Process outputs are the results of any activities which are ready for delivery to the organization’s customer or to an internal customer (e.g. receiver of the inputs to the next process); they can include products, services, intermediate parts, components, etc

8.5.3 Property Belonging to Customers or External Providers

The Requirement

The organization should exercise care with property belonging to customers or external providers while under the organization’s control or being used by the organization. The organization should identify, verify, protect, and safeguard the customer’s or external provider’s property provided for use or incorporation into products and services. It should report to the customer or external provider when their property is incorrectly used, lost, damaged, or otherwise found to be unsuitable for use. Customer property can include material, components, tools and equipment, customer premises, intellectual property, and personal data.

Checklist Questions

1. What care does the organization provide for customers or external provider’s property while under its control?
2. How does the organization identify, verify, protect and safeguard the customer property which is provided for use or incorporation into products or services?
3. What means does the organization use to report to the customer or external provider if their property is incorrectly used, lost, damaged, or found to be unsuitable for use?

Implementation Guidelines

1. Customer or External provider property may include material, production equipment, tooling, measuring and test equipment, facilities, transport vehicles, returnable packaging, intellectual property such as drawings, specifications or proprietary information, product returned for servicing under warranty, product sent for outsourced work, etc.
2. All customer property is exposed to the risk of being damaged, lost, misused, misplaced, stolen, become unsuitable or obsolete for use. Notify the customer/ External provider in writing if their property is lost, damaged, or otherwise found to be unsuitable such as perishable past its shelf life for use
3. Control to minimize the risks to customer/External provider property include inventory management, preservation, and storage, identification, status and traceability indicators, maintenance, notification, traffic flow, authorized use, restricted access, etc.

8.5.4 Preservation

The Requirement

The organization should ensure the preservation of “process outputs” during production and service provision, to the extent necessary to maintain conformity to requirements. Preservation can include identification, handling, packaging, storage, transmission or transportation, and protection.

Checklist Questions

1. How the organization does ensure the preservation of process outputs during production and service provision to maintain conformity to product requirements?

Implementation Guidelines

1. Preservation can include identification, handling, packaging, storage, transmission or transportation, and protection.
2. All raw materials, work in progress, finished product, supplies, customer provided materials or product, product sent for outsourced work, etc., are subject to the risk of being damaged, lost, misused, misplaced, stolen, become unsuitable, perishable, or obsolete i.e. past shelf life for use.
3. These could be controlled using identification, status and traceability indicators, inventory cycle counts and condition evaluation, stock rotation methods such as FIFO, just in time, tracking shelf life, special, controls for restricted access, handling and storage of hazardous materials, climate and environment, maintenance procedures, barcodes, training, use of special equipment for handling, condition reports, etc.
4. Documented information may be included in your product realization processes through your product quality plans, work instructions, and other specific documentation.

8.5.5 Post-Delivery Activities

The Requirement

The organization should meet requirements, as applicable, for post-delivery activities associated with products and services. In determining the extent of post-delivery activities that are required the organization should consider risks associated with products and services; Customer feedback; legal requirements; nature, use, and intended lifetime of products and services; Post-delivery activities can include actions under warranty provisions, contractual obligations (such as maintenance services) and supplementary services (such as recycling or final disposal)

Checklist Questions

1. How does the organization meet requirements for post-delivery activities associated with products and services?
2. When determining the extent of post-delivery activities required with products and services, How does the organization determine the risk, customer feedback, and Nature, use, and intended lifetime?

Implementation Guidelines

1. Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.
2. Post Delivery activities mean based on customer agreement or other agreement, the organization may be responsible for providing support for their product or services after delivery. This could include technical support, routine maintenance or total recall, recycling, reusable packaging, returnable containers, etc.
3. The extent of post-delivery activity will depend on statutory and regulatory requirements, the potential undesired consequences associated with its products and services, the nature, use, and intended lifetime of its products and services, customer requirements, and customer feedback.

8.5.6 Control of Changes

The Requirement

The organization should review and control changes for production or service provision to the extent necessary to ensure continuing conformity with requirements. The organization should retain documented information describing the results of a review of changes, personnel authorizing the change, and any necessary actions arising from the review.

Checklist Questions

1. How does the organization review and control unplanned changes to ensure continuing conformity with specified requirements?
2. What documented information does the organization has which describes the results of reviews of changes, the personnel authorizing change, and any necessary actions?

Implementation Guidelines

1. Changes, in general, create instability, and a robust change management process is critical to ensure changes are fully reviewed, approved, communicated, understood, and validated when they are implemented. Records describing the results of the review of changes, personnel authorizing the change, and any necessary actions arising from the review have to be maintained.
2. The organization is required to review and control changes for all of the previously discussed “production and service provision” topics including 8.5.1 Control of production and service provision (all of the controls established in the first place), 8.5.2 Identification and traceability, 8.5.3 Property belonging to customers or external providers, 8.5.4 Preservation and 8.5.5 Post-delivery activities.

8.6 Release of Products and Services

The Requirement

The organization should implement planned arrangements at appropriate stages to verify product and service requirements have been met. Retain evidence of conformity with acceptance criteria. The release of products and services to the customer should not proceed until the planned arrangements for verification of conformity have been satisfactorily completed unless otherwise approved by a relevant authority and, as applicable, by the customer.  The organization should retain documented information for traceability to the person(s) authorizing the release of products and services for delivery to the customer. The organization should also retain documented information for evidence of conformity with the acceptance criteria. 

Checklist Questions

1. Show how planned arrangements have been implemented at appropriate stages to verify product and service requirements have been met. Show what evidence the organization retains.
2. Show how the release of products and services is held until planned arrangements for verification of conformity have been satisfactorily completed unless approved by a relevant authority, or the customer if applicable.
3. Show documented information that shows traceability to the person authorizing the release of products and services.

Implementation Guidelines

1. Before you release your product to your customer, You must plan what characteristic(s) to measure, type of measurements, what measurement device to use, how often to measure, sample size, acceptance criteria, and records needed for each product or product type. Use your quality plan to document these controls. Where practical, consider completing all missed planned inspections and measurements before product delivery.
2. If you plan on releasing during any stage of production or shipping finished product, where all planned inspections and measurements to that stage have not been completed, ensure that you obtain prior written approval/waiver from a relevant internal authority or the customer.
3. You must identify and document all product realization processes e.g. receiving, production, shipping, etc. For such processes, you must also identify what specific documents are needed for effective planning, operation, and control.
4. You could use a product quality plan, any documented information, or other combination of specific practices, procedures, and methods.

8.7 Control of Nonconforming Process Outputs, Products, and Service

The Requirement

8.7.1 

The organization should ensure process outputs, products, and services that do not conform to requirements are identified and controlled to prevent unintended use or delivery. The organization should take appropriate action based on the nature of nonconformity and its impact on the conformity of products and services. This is applicable also to nonconforming products and services detected after delivery of products during or after the provision of service. The organization should deal with nonconforming outputs in one or more of these ways:

• correction;
• segregation, containment, return, or suspension of the provision of products and services;
• informing  the customer;
• obtaining authorization for acceptance under concession. 

The organization should verify conformity to requirements when nonconforming process outputs, products, and services are corrected.

8.7.2

The organization should retain documented information that describes the nonconformity, action taken,  concessions obtained, identifies the person or authority that made the decision regarding dealing with nonconformity.

Checklist Questions

1. How the organization does identify and controls process outputs, products, and services that do not conform to requirements and prevent their unintended use or delivery?
2. What appropriate corrective actions are taken based on the nature of the nonconformity and its impact on the conformity of products and services? How the organization does apply this to nonconformity detected after delivery?
3. How the organization deals with nonconforming process outputs, products and services in terms of:

a) Correction;b) Segregation, containment, return, or suspension of the provision of products and services? c)  Informing the customer? d) Obtaining an authorization for use as-is? e) Release, continuation, or re-provision of the products and service? f) Acceptance under concession?

1. How the organization does verify conformance where process outputs, products, and services are corrected following nonconformance?
2. What documented information is kept following actions taken to address nonconformities, including any concessions obtained and on the person or authority that made the decision regarding dealing with the nonconformance?

Implementation Guidelines

1. This is applicable to processes, products, and services that do not conform to customer requirements, applicable regulatory requirements, or your own organization requirements. Nonconformities may relate to suppliers and outsourced work, organizational activities, or products shipped to customers.
2. The organization must have controls and responsibilities to identify, contain i.e. prevent further processing or use, keep records of the nature and other details of the nonconformity, notify appropriate personnel and customer, where appropriate, evaluate what disposition action needs to be taken, carry out timely disposition, determine policies for release for further processing or shipment to the customer, obtain customer concessions, rework and re-verification, establish performance indicators to measure the effectiveness of the control of nonconformance process, etc.
3. Product or material found with no identification or its quality status is not known, should be treated as a nonconforming product and controlled as mentioned above.
4. If you find that a nonconforming product has been shipped, without a customer concession, you must take appropriate action to reduce the immediate and consequential effect of the nonconformity.
5. Depending upon the seriousness and scope of the nonconformity, you might consider taking action to eliminate the nonconformity as well as a corrective action to eliminate the root causes of the nonconformity.
6. It might be appropriate in specific circumstances to notify the customer and resolve the situation to your customer’s satisfaction.
7. You need to be aware of any reporting requirements imposed by regulatory bodies and comply with them.
8. All product realization processes must show the interaction with your process for a nonconforming product.
9. A concession authorization allows you to ship nonconforming products, under controlled conditions.
10. A deviation authorization allows you to manufacture a product different from the original specification, under controlled conditions.
11. In both these situations, make sure that you obtain these authorizations in writing prior to shipping or manufacturing a nonconforming product.

Documented Information if applicable

1. Process Quality plan
2. Production plan and status
3. Contract Review Checklist
4. Risk Assessment – Business Enquiry
5. verbal order Register
6. Input Adequacy Report
7. Design Data Input Sheet
8. Design and Development plan
9. Design change record
10. Design Review Record
11. Design verification record.
12. Design validation record
13. Design output record
14. Approved Supplier List
15. Supplier Corrective Action Request (SCAR) Log
16. Supplier performance report
17. Supplier & Subcontractor Assessment Form
18. Purchase order
19. Receipt Inspection Report
20. Daily Production & Inspection Record
21. Breakdown Maintenance Report
22. Preventive Maintenance Chart
23. Tags
24. List Of Customer Drawing
25. List Of Customer Supplied Items
26. Stock Register
27. Sample Maintenance agreement
28. Pre Dispatch Inspection Report
29. Nonconforming Part Disposition
30. Nonconforming Service Report
31. Out of tolerance impact study

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