Example of Quality Manual based on ISO 29001:2020

0. Introduction

0.1 The Company

// Include your company profile

0.2 Products & Services

// Include your company’s product and services

1. SCOPE

This is the official quality management system manual of XXX. It describes the approach, structured to comply with the ISO 29001:2020 Quality management system (QMS). This system applies to all activities and operations performed at XXX. Through this Quality management system XXX,

Demonstrates the ability to provide consistently products and services that meet customer and applicable statutory and regulatory requirements
Aims to enhance customer satisfaction through the effective application of system, including processes for improvement of the system and assurance of conformity to customer and applicable statutory and regulatory requirements
To have a systematic approach to environmental management that will provide information to build success over the long term and create options for contributing to sustainable development, the organization and interested parties.

2. NORMATIVE REFERENCES

Documents related to this integrated management system manual include:

ISO 29001:2022, Petroleum, petrochemical and natural gas industries — Sector-specific quality management systems — Requirements for product and service supply organizations
Annex 001 of QMS manual Quality policy statement
Annex 002 of QMS manual Process interaction chart
Annex 003 of QMS manual Organization chart,
Annex 004 of QMS manual QMS Objectives (A, B and C)
Annex 005 of QMS manual Scope document

3 TERMS AND DEFINITIONS

Quality management system: a set of interrelated and coordinated activities to direct and control an organization with respect to quality. The advantages of conducting an quality management system approach are:

Providing a framework for continual improvement to increase the probability of enhancing customer satisfaction and the satisfaction of other interested parties.
Ensuring that the service level provided by the company satisfies customers’ stated and implied needs.
The implementation of such system will lead to minimizing non-conformity level and eliminating their causes.
Increasing the potential for improvement of the organization.

Note: A Management system is a set of interrelated elements used to establish policy and objectives and to achieve those objectives. A management system includes organizational structure, planning activities (including for example, risk assessment and the setting of objectives) responsibilities, practices procedures, processes and resources.

Integrated management system manual: a document specifying the quality, health, safety and environmental management system of an organization. The integrated management system manual is an overall controlling document that contains full reference to all supporting operational procedures that describe the routine functioning of each department within QBC.
QHSE policy: the overall intentions, objectives, and directions of an organization related to quality, health, safety and environmental management system.
Quality plan: specification of the procedures and associated resources to be applied when and by whom to a specific object.
Resources: all needed requirements that enable the organization to fulfil all the client’s requirements. Resources could be one of 4 M’s: Material, Manpower, Machines, and Money.
Procedure: documentary instructions to the operation of the related integrated management system of the standards and defining responsibilities and activities for the operations.
Internal Audit: Systematic, interdependent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the environmental management system audit criteria set by the Organization are fulfilled
Infrastructure: Organization (system) of facilities, equipment and services needed for the operation of an organization
Incident: Work related event(s) in which an injury or ill health ( regardless of severity ) or fatality occurred or could have occurred
Improvement: Activity to enhance performance
Non Conformity: Non fulfilment of requirement
Performances: Measurable results of an organization’s management of Risk (in terms of all applied standards)
Risk : Effect of uncertainty
Validation: Conformation, through the provision of objectives that the requirements for the specific intended use or application have been fulfilled

4.0 CONTEXT OF THE ORGANIZATION

4.1 Understanding the organization and its context

XXX reviews and analyses the key aspects of itself and its stakeholders to determine the strategic direction of the organization. Internal and external issues that make impact on the XXX’s core business process and its stakeholder’s interest are taken into consideration, monitored and implemented. Changes in the market, technologies, laws, regulations, economy, government policies competitors, cultural and social responsibilities, are also being taken into consideration while carrying out business operation, by:

Understanding our core products and services, and scope of management system
Maintaining a Register for the internal and external issues determined by XXX which is reviewed annually.
Identifying “interested parties” (stakeholders) who receive our (Products or Services), or who may be impacted by them, or those parties who may otherwise have a significant interest in our organization’s business. These interested parties are identified during the management system risk assessment process

Note: Outsourcing of activities are strictly controlled and ensured that the requirements of the product and QA/QC requirements of the XXX are maintained throughout the product manufacturing lifecycle.

Ref: Risk assessment (PR 002)

4.2 Understanding the needs and expectations of the interested parties

Understanding needs and expectations of the interested parties are of key concern to XXX and have ensured through regular meeting with relevant section managers to clearly understand who they are and how they can affect the organizational ability to consistently perform. For this XXX,

Maintains a register for determining who are the relevant interested parties and are monitored in regular frequency (annex to the risk assessment procedure)
Regularly updates the needs and expectations of the interested parties so that they are clearly understood and met
Where applicable to be added as legal and other requirements the respective process owners shall inform the management and update it.

This information is then used by the top management (General Manager) to determine the XXX’s strategic direction. This is defined in records of management review, and periodically updated as conditions and situations change.

Ref: Risk assessment (PR 002)

4.3 Determining the scope of the QMS

Based on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its products and services, XXX has determined the scope of the management system. The QMS is structured to provide a robust, comprehensive, and a continuously improving management system in a manner that ensures customer satisfaction, an improved Quality performance. For determining the scope the organization, has considered

the external and internal issues
the requirements relevant to the interested parties
the products and services of the organization,
the works related activities performed
organizational functions and physical boundaries
the compliance obligations
Its authority and ability to exercise control and influence

The scope the QMS for XXX is documented below,

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All the requirements given in the standards ISO 29001:2022 are applicable to the scope of XXX and same is advised to the interested parties as determine in 4.2 when requested by them.

4.4 Quality management system and its processes

The QMS has been established in line with the ISO 29001:2020 standard to implement, maintain and continually improve the effectiveness of the system as well as the business processes of XXX. For effective implementation the following has been:

Identified and determined:

Process flow and their sequence, major processes through process flow which are identified in document master list;
All the key processes, its applications and its interactions through process interaction chart (Annex 002);
Aspects which have significant impact on the environment, achievable programs for continual improvement;
Assessed risks which have been rated as extremely high and control measures and supporting action plans as and when required.
Management system risk identification, determination of risk treatment and opportunities for improvement for all critical management system activities within the organization
Processes and documented information required to meet the requirement of interested parties.

Defined:

Operational criteria;
Policy statement, objectives and targets for quality processes;
Measuring and monitoring of aspects from various activities/process which have significant impact on the risk control activities, management system risk assessment and risk treatment, through various clauses of this manual, established procedures, work instructions and job descriptions;
Details of activities of the company through procedures, work instruction, process flows and various clauses of this manual;
Method of control through established documents which are listed in document master list (QMSF002);
Method for periodically reviewing and evaluating the quality management system, as well as to identify the opportunities for improvement;
Outsource processes and their controls which affect the product conformity are identified through purchasing procedure (Controls applied to externally provided services PR-008).

All the above mentioned processes are established, documented, implemented, monitored and analyzed for the performance to achieve the planned results and continual improvement of these processes as per analysis of data and management review as detailed later in this manual. The system is applicable to all the activities, product, processes and services of XXX. For adapting to changing circumstances, XXX shall be periodically reviewing and evaluating its management system in order to identify the opportunities for improvement and their implementation.

5.0 LEADERSHIP

5.1 Leadership and commitment

5.1.1 General

The XXX’s top management which includes the General Manager is committed to the implementation and development of the documented QMS and to continually improve the effectiveness of the system by:

Taking accountability for the effectiveness of the Quality management system, including prevention of work-related injury and ill health, as well as the provision of safe and health workplaces and activities.
Ensuring that the Quality policy statements and objectives are established for the QMS is compactable with the context of the organization and strategic direction of the organization.
Ensuring that the integration of the QMS requirements into the business processes
Promoting risk based thinking and process based approach
Communicating to the company the importance of meeting the customers as well as statutory and regulatory requirements.
Establishing and communicating the company policy to all employees in the company and explaining that satisfying the requirements of the Quality management system will lead to effective implementation of the company policy.
Ensuring that all necessary resources whether human, financial, equipment, or material are available for efficiently conducting Quality management system tasks.
Providing the proper training for newly hired employees as well as the available employees in order to be able to perform all job requirements and duties each in his position.
Assuring that, where necessary, personnel have the authority to identify and record quality problems requiring resolution and analysis, or improve the applied systems and procedures after communicating them to the related department head and the management representative.
Ensuring that there is active participation of workers in QMS system and removing any barriers or obstacles to participation.
Initiating, recommending, and providing solutions to prevent the occurrence of non-conformance.
Ensuring that the QMS achieves its intended results.
Engaging, directing and supporting persons to contribute to the effectiveness of the QMS.
Promoting and ensuring continual improvement in all the processes.
Promoting and leading a positive culture with regards to the Quality management system.
Protecting workers from reprisals when reporting risks and opportunities.
Supporting all the relevant process owners and managers in their roles to demonstrate leadership and to achieve the indented result of the QMS.

5.1.2 Customer focus

XXX ensures that all the customer requirements are determined and fulfilled to meet their expectations and thereby achieving customer satisfaction. The management system is established and maintained keeping in view the further enhancement of the same by:

Determining requirements stated and implied by customer
Identifying, establishing, maintaining and updating the legal and statutory requirements those which are applicable to the activities, products or services provided.
Ensuring that the customers are aware of the requirements related delivery and post-delivery activities
Identifying the environmental aspects of its activities, which have significant impact on the environment, and informing the customer, employees and interested parties them about the significance, where required.
Implementation of necessary control measures to ensure that customers have a risk free product or service.
Providing information related to products and services through company profile.
Ensuring that the risks and opportunities that can affect the conformity of products and services are and the ability to enhance customer satisfaction are determined and addressed
Ensuring that the focus on enhancing customer satisfaction is maintained.

5.1 Policy

5.2.1 Establishing the QUALITY policy

In XXX, the QUALITY policy has been made in line with the requirements of ISO 29001:2020. The QUALITY policy statement has been defined and published and can be found with the General Manager endorsement in the QMS manual. The top management shall establish, maintain and implement the policy based on the discussion and agreement with the process owners in considerations of the interested parties. The strategy to achieve the company policy is through the implementation and maintenance of very well established objectives, which provides a framework for implementing the Quality management system described in this manual, compliance to applicable legal and other requirements and the associated procedures. The policy statement shall be reviewed (and revised as needed) during management review to ensure the continuing suitability to the established QMS and the changing needs of the customer.

5.2.2 Communicating the QUALITY policy

Employees at all levels of the organization are expected to understand and fulfil the requirements of this policy in all of their works, related efforts and decisions. The top management shall ensure that the commitment to workers participation and consultations are documented and demonstrated. The QUALITY policy is considered as a major part of the Quality management system; accordingly it shall be reviewed for continuous suitability and its support in the strategic direction of the company. The top management have ensured that the policy is

Available and maintained as documented information
Communicated, understood and applied within the organization through effective communication, training and supervision
Available for relevant interested parties as applicable through brochures, manuals, websites, etc.
QUALITY policy statement is also included in the induction training of the new employees as well as in the QMS training, contractor’s training and process trainings conducted periodically

Ref: QUALITY policy statement (Annex 001)

5.3 Organizational roles, responsibilities and authorities

The organizational chart (in Annex 03) provides the positions of all that manage, perform and verify works affecting quality. All relevant roles are well defined in each procedure. The responsibilities, accountability and the authorities of all relevant affecting QMS, facilities and processes are defined through the

Employment offer
Contract agreement (Recruitment phase)
Organization chart,
Job descriptions
Induction training, On job training
Internal memos/tool box meetings
Trainings – refreshment and development

The top management ensures that all the assigned roles have their responsibilities and authorities defined and communicated effectively. The steps taken shall ensure that the requirements of the established Quality management system are well understood by the process owners and employees to confirm to the ISO 29001:2020 standard as well as the desired outputs from the team. The top management shall ensure that the performance of the Quality management system and opportunities for improvement are identified and communicated to them by the process owners. The process owners shall ensure that the objectives and performance indicators of the intended outputs are reported to the Top Management. The job descriptions of the individual are communicated through training (induction/on job), regular meetings, notice boards and work instruction. Apart from the defined responsibilities, accountabilities and authorities, respective process linkages and the interrelation of the all the organizational processes are defined in process interaction chart (Annex 02).

6.0 PLANNING

6.1 Actions to address risks and opportunities

XXX shall ensure that the risk assessment is done for the critical processes, products and services within the Quality management system. While performing the risk assessment and opportunity identification, XXX shall ensure that

The relevant internal and external issues related to the products and services are considered
The needs and expectations of the external interested parties which affects the products and services are incorporated
The techniques, tools and their application for identification and assessment of risks and opportunities, and prevention and mitigation of risks are determined;
The sources of risk and opportunity, areas of impacts, events and their causes, and their potential consequences are determined.
The potential risk and opportunity by determining consequences and their likelihood are analysed ;
The risk and opportunity and develop controls for them are evaluated;
Appropriate risk treatments and opportunity realization plans are applied.

The details of the methodologies used for identification of risks and opportunities are documented in the procedure for management system Risk assessment (PR 002). Formal risk management may not be utilized in all instances; instead, the level of risk assessment, analysis, treatment and record keeping will be performed to the level deemed appropriate for each circumstance or application. XXX considers risks and opportunities when taking actions within the management system, as well as when implementing or improving the management system; likewise, these are considered relative to products and services.

Ref: Risk Assessment (PR 002).

6.2 Objectives and planning to achieve them

Objectives (Annex 04) shall be in line with the stated quality policy, measurable and monitored. The General Manager in co-ordination with the respective section manager(s) reviews and recommends, where needed, to process owners to revise the objectives in the management review meeting to ensure that the objectives are relevant to the conformity of products and services provided to the customers and serves to enhance customer satisfaction. The top management worked on establishing objectives that are extracted from XXX’s company policy. The management made sure that the objectives are:

Consistent with the QUALITY policy statement
Established after taking into account the applicable legal and other requirements
SMART: Specific, Measurable, Achievable, Realistic and Timely.
Established risks including the commitments to the prevention of injury and ill health, legal and other requirement, technological options, financial, operations and business and the views of interested parties
Established at relevant functions and levels within the organization for achieving conformity to products and service requirements and to enhancement of customer satisfaction and are monitored through objective measurement charts.
Planning taking into account, the applicable requirements, results of the risks and opportunities, results of consultation with workers and QUALITY representative
These objectives shall be reviewed continuously through the management review meetings and internal audits as described in the management review procedure for suitability and updating.

While planning for achieving the objectives are met, the process owners shall determine;

What will be done
What resources will be required
Who will be responsible
When it will be completed
How the results will be evaluated

Ref: Functional quality objectives (Appendix 04),

6.3 Planning of changes

When the organization determines the need for changing the Quality management system, the changes shall be carried out in a planned manner. When there are changes required in the existing service requirements, management ensures through management review that the suitability & integrity of the management system is maintained during the planning and the implementation to the smooth transition of the system. When changes are required existing objectives, the Management Representative shall ensure through review the purpose and potential consequences of the change and its suitability and integrity with the existing QMS. In case of need for availability of resources or need for the allocation or reallocation of responsibilities and authorities for the changes in the objectives, it shall be duly addressed prior to formalizing the objectives. Management programs, identified risk control measures and Action Plans are amended, if required. If necessary, planning is also carried out through review meetings. Any risk and opportunities arising out of the changes are managed as per the procedure of Risk assessment.

Regarding management of change (MOC) the organization shall identify the risks associated with changes in the organization, Quality management system, or its activities, prior to the introduction of the changes. The organization also ensures that the results of these assessments are considered for determining the appropriate controls. Documented Information for the management of changes are maintained. The relevant process owners along with the Management Representative shall plan to take actions to address its changes to the management system processes.

The Management Representative along with the process owners shall review and determine how to integrate and implement the relevant actions into the Quality management system and shall evaluate the effectiveness of these actions and shall consider

The purpose of the changes and its potential consequences
The integrity of the QMS
Availability of resources
Allocation of re-allocation of responsibilities and authorities

The requirements for quality requirements are met by the establishment and implementation of Quality management system which allows effective planning prior to the changes in the system.

The Quality management system has been assembled and documented in a format to suit this method of operation.
XXX will give timely consideration to conduct revision of the Quality management system through management review meetings, and interactions with the process owners.

While planning its actions XXX shall ensure the best practices, technological options, financial, operational and business requirements are met.

Ref: Management of change (PR 021)

7.0 SUPPORT

7.1 Resources

7.1.1 General

XXX’s Top management has assured the availability of resources needed for the effective implementation and the maintenance of the QMS and enhance the effectiveness of the system by providing resources on time. The General Manager shall consider the capabilities of, and constraints on, existing internal resources and what it needs from the external providers. By providing resources on time, the management ensures that there is:

Continual improvement in the QMS.
Enhances customer satisfaction by meeting and exceeding the requirements of the customer

7.1.2 People

XXX’s Top management has ensured that there are adequate personals available for the services provided and to enhance the quality performance of the Quality management system. Personnel performing work affecting service are competent on the basis of appropriate education, training, skills and experience. The top management ensures this through proper recruitment of the most appropriate personnel for the required jobs. Competence requirements are determined through job descriptions. Where additional training is required to enhance the competence of personnel, this is handled in accordance with Procedure for Training (PR 007).

The Admin/HR Representative ensures that the process of requirement of competent people is being arranged for the respective department either through recruitment or through outsourced activities.

Ref: Training (PR 007)

7.1.3 Infrastructure

The infrastructure facilities required to achieve planned results (as per the scope of service) are identified and maintained as per procedure for Maintenance (PR 022), this includes,

All equipment required for provision of services (is identified and made available).
Risk based Maintenance activities are carried out which includes preventive and predictive maintenance, reliability centred maintenance, mean time between failures, system, design and process failure mode and effects analysis, failure mode and criticality effects analysis, process control plans and others that are in context of the organization and its risks.
Software and hardware (information systems) (used are controlled and maintained to ensure the availability of licensed and updated versions as required).
Equipment and supporting services (are identified and maintained as per the established preventive maintenance system).
Preservation – (Incoming materials and finished products are maintained as per the required conditions by providing adequate storage and protection).

The availability of the process equipment and supporting services such as communication and transport are reviewed by top management during the management review meeting and internal meetings, for the capability to meet to the requirements of customers (both internal and external) and interested parties. XXX ensures the availability of latest versions of software that may be needed for carrying out the activities as required. Arrangements are made with the relevant suppliers for updates.

Ref: Maintenance (PR 022)

7.1.4 Environment for the operation of processes

The present work environment is determined to be suitable for the range and scopes of services carried out. The process owners ensure that the environment for operational process are defined and complied to.

The respective managers along with the QA/QC representative reviews the suitability of the work environment needed to achieve the conformity of the product requirements and to enhance the organization in achieving the quality requirements on a regular basis.

A work environment suitable for achieving conformance to product requirements are maintained. Data from the QMS system is also evaluated to determine if the work environment is sufficient for achieving conformance to the requirements, or if corrective action related to the work environment is to be taken. The present work environment is determined to be suitable to the range and scopes of the service carried out by XXX:

Work instructions are available for all general safety rules.
Safety rules and protective equipment – To create awareness, respective safety instructions are displayed and provided with the necessary protective equipment.
Other welfare facilities are also provided to the employees like drinking water facility, transport from the accommodation to the work place, free accommodation facilities and food.
Proper housekeeping is maintained taking safety into consideration.
Dust free atmosphere for critical processes
Maintaining the environment by planting trees and promoting greenery in the camp areas. Providing adequate breaks for staff to ensure that they are not over stressed
Motivating employees through performance appraisal, incentives, and real involvement of employees.

Note: The term “environment for the operations of processes” relates to those conditions under which work is performed including physical, environmental and other factors (such as Social, Psychological, physical)

Top management reviews the suitability of the work environment needed to achieve the conformity of the product requirements and to enhance the organization in achieving the QUALITY policy, objectives, targets and system performance etc. through management review meeting.

7.1.5 Monitoring and measuring resources

7.1.5.1 General

XXX’s Top management considers providing resources as one of its top priorities in having an effective Quality management system, so when it comes to monitoring and measuring resources, the management ensures that it provides those resources which will give valid and reliable results for its products and services. The management shall ensure that these resources are suitable for the specific type of monitoring and measurement activities of XXX and are maintained by the authorized person for continuing fitness for their purpose.

Ref: Measurement and Monitoring (PR 025)

7.5.5.2 Measurement traceability

All inspection, measuring, and test equipment used for demonstrating the conformity of the product is controlled and maintained on a regular basis. A list of measuring equipment shall be established to define accuracy needed and frequency of calibration. Such measuring and test equipment is subject to either external calibration by independent bodies or in house by qualified personnel (where applicable). Results of calibration, indicating calibration status, shall be recorded and maintained. Calibration data or results will be afforded to customer on request. Calibration certificates shall provide traceability to national or international standards. Defective equipment shall be taken out of service for repair or disposal. If defective equipment was used to verify product acceptance the effect upon product quality shall be re-assessed. If calibration is carried out in-house, it will be done under suitable environmental conditions by qualified personnel. Master instruments traceability will be to the international or national standards. All master instruments will be maintained, protected from damage or loss to sustain accuracy needed. The calibration and control of monitoring and measuring devices is explained in the calibration procedure

Ref: Calibration procedures (PR018)

7.1.6 Organizational knowledge

XXX’s top management values the knowledge and skills of the employees that it has recruited and shall strive towards maintaining them within the organizations for growth and effectiveness of the processes. XXX’s top management shall determine knowledge necessary to perform process/operations to meet customer expectations and subsequently, plan the methods to achieve the identified knowledge goals by means of training, learning on the job etc.

XXX shall exchange in-house and maintain this knowledge through internal knowledge sharing sessions which ensure dedicated exchange of knowledge and sharing of lessons learned from projects and specific external training programmes.

The respective process owners and top management shall evaluate knowledge and identify opportunities for improvement in line with changes in the market or in technology and analyzing the extent to which they influence the knowledge that XXX requires.

7.2 Competence

Competence requirements are determined through job descriptions. Where additional training is required to enhance the competence of personnel, this is handled in accordance with Training procedure (PR 007).

The HR department ensures that the process of recruitment of competent people is being arranged for the respective process either through recruitment. It is the responsibility of the respective manager to ensure that all personnel carrying out activities are made aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives and the importance of conformance to XXX’s QUALITY policy, Quality procedures. Company objectives are deployed at the functional levels and all relevant personnel made aware of their roles.

In terms of QMS, the management shall ensure that actions taken to ensure competence, shall take into account

The Risk and Opportunity assessed by the organization
Preventive and control measures resulting from the risk assessment process
Assigned roles and responsibilities
Individual capabilities, including experience, language skills and literacy
The relevant updating of competencies made necessary to the context of the work changes
The evaluation of the competence or workers according to the determined necessary competence

Ref: Training procedures (PR 007)

7.3 Awareness

XXX’s top management understands and maintains that it is the responsibility of the respective manager to ensure that all personnel carrying out activities are

Made aware of the QUALITY Policy statement, relevant objectives, customer & regulatory requirements, risk mitigation and conformity assessment requirements.
how they contribute to the achievement of the Quality management system and the benefits of the enhanced performance
the implications of not conforming with the Quality management system, including consequences, actual or potential to their work activities
Information and lessons learned concerning Quality issues

Awareness sessions shall be carried out through the established training procedure and the by the procedure for communication, participation and consultation.

Ref: Training procedures (PR 007)

7.4 Information and communication

The internal communication among XXX’s staff is ensured by the well-established reporting system, which is covered by the application of the ISO 29001:2020 Quality management system. Records and information flow are available through two kinds of media: soft copies through the active networks and through hard copies. The process sequence, linkage/interrelation, interactions, method of operation and control and process criteria of monitoring and measurement are carried out as stated in general requirement and are communicated across all levels of the organization through the QMS. As a part of this QMS, effective communication is established throughout organization via:

Internal memo
Intranet
Verbal instructions
Display of quality policy statements and objectives
Circulars
Monitoring and measurement reports

Method for receiving, documenting and response to relevant communication from external interested parties of has been defined in the procedure for communication, participation and consultation (PR 012).

XXX’s top management has decided to communicate externally about its significant environmental aspects to interested parties if they ask or enquire about it. It will be the responsibility of the management representative on how to give a report to the interested parties on any Quality matters. Change of decision to communicate would be discussed during MRM and method for the same will be finalized.

A clear method of communication internal and external has been identified and defined in procedure for communication(PR012). Method for internal communication among the various levels and functions of XXX has been defined in the same procedure. With respect to information to external or interested parties, XXX shall ensure that they

Define the intent to be achieved by informing and communicating and shall evaluate whether the objectives have been met
Take into account diversity aspects, where they exist, when considering its information and communication needs

Ref: Communication (PR 012).

7.5 Documented information

XXX has established a documented procedure to maintain control of all documents and data relating to the requirements of ISO 29001:2020 standard. This also includes, if applicable, documents of external origin determined by XXX to be necessary for the planning and operation of the quality management system, such as standards and/or customer supplied documents.

The documented procedure covers the following issues:

The management representative is responsible for the issuance, amendment and recall of the entire documented Quality management system.
Amendments to the documented system may arise at any time as a result of but not limited to the following:
Changes to the Quality management system standard,
Internal and external audits.
Changes in technical standards.
System reviews.
Requests for amendments from Concerns.
Business expansion, development and improvement.
Amendments to the Quality management system might be requested by any employee and are forwarded to the management representative using the appropriate document as stated in the documents control procedure (PR 001)
The management representative shall review and approve any amended/new document for adequacy prior to issue.
To ensure that documents remain legible and readily identifiable, the management representative holds a copy of the current version of the Quality management system documents as a master reference in the system master file.
The document controller is responsible for issuing all manuals and maintaining a log of all issues. The Quality management system, which includes all approved documents, is distributed to all locations/departments where operations essential to the effective functioning of the QMS management system are performed.
Quality manual, procedures, and support documentation are issued as “controlled” documents.
When a change to the documented system has been agreed, the management representative advise all the internal document holders of the new revisions by changing the revision in the documentation master list and distributes this new version to all the holders.
All obsolete and/or invalid documents shall be taken from the holders and disposed.
The document controller retains copies of the superseded documents for a stated period of time.
Documents of external origin determined by XXX to be necessary for the planning and operation of the Quality management system shall be identified and their distribution shall be controlled.
Practices employed by XXX to integrate into its operating process any external specification requirements, including addenda, errata, and updates, used in the design or manufacture of a product or service,

XXX has established documented procedures for records control (PR 001) whereby the records are retained for defined periods, identified, filed/stored, maintained, and are always accessible and retrievable. Records may be in hard copies, electronic copies or other media formats. Where information is stored in a computer system, appropriate methods are taken to preserve data including data back-up copies.

The documented procedure includes controls for:

Records identification: this is covered in the documentation procedure (PR 001) where each record has a unique identification number and revision number.
Records storage and protection: all records shall remain legible by using appropriate storage methods to guarantee that they are readily retrievable. They are stored in a manner that prevents loss, damage, or deterioration.
Retention and disposition of records: retention period is stated for each record after which records are disposed. The retention period is specified according to the importance and the need of the document for a specific period of time.
Retained records demonstrate conformance to the ISO 29001:2020 and requirements and provide evidence of the effective operation of the Quality management system. Also, these records are considered as the basic input for the analysis of data used for measuring and improving the applied activities and processes.

Ref: Documented information procedure (PR 001)

8.0 OPERATION

8.1 Operational planning and control

8.1.1 General

Planning and realization of service is an on-going process. The controls needed to achieve service conformity are established and maintained through various process flow diagrams or procedures. Procedures and process flows diagrams for the key processes are documented. During planning the following are determined:

The requirements of the customer’s scope and product characteristics
The need to establish criteria for processes and acceptance of the products and services
The needs of resources to achieve conformity to the product and service.
Required verification, validation, monitoring, inspection and test activities specific to the requirement and the criteria for service acceptance. (Calibration of key equipment, validation, inspection and test activities as per quality plan/requirement)
Implementation of controls for the criteria
Records needed to provide evidence that the realization process (planning, review, production, delivery, etc) and resulting outputs meets contractual and product requirements.
The output of this planning process is the product itself and the records to prove its acceptance/service requirements by the customer shall be maintained.

Where required the respective section managers shall control planned changes and review the consequences of unintended changes taking action to mitigate any adverse effects as necessary. The outsourced processes shall be controlled and records maintained for conformity. Where there is a requirement by the client for Quality / Service plan or Inspection and test plan, the QA/QC representative and the respective section manager shall prepare a quality plan or Inspection and test plan and submit for approval.

Changes to operational processes are done in accordance with the procedure for Management of change(PR 021).

Contingency plans are established as a risk treatment in accordance with the Procedure for Contingency plan (PR 023).

Ref: Management of change (PR 021), Contingency plan (PR 023).

8.2 Requirements for products and services

8.2.1 Customer communication

For the effective implementation to meet the requirements of customer, appropriate channels of communication are established in relation to product information, enquiries, contracts, order handling, amendments, contract information, enquiries, and feedback including customer complaints etc.

The various modes of communication used are:

E- mail through Internet
Fax/Letters
Telephone
Displays
Personal meetings with clients
Brochures
Visits of clients to facilities

The complaints received from the customers are reported in Customer Complaint Register where required. Customer communication records are also retained throughout the project, or until the project is declined. The method for handling complaints is identified in the procedure for communication, participation and consultation (PR-012).

Ref: Communication, participation and consultation (PR 012).

8.2.2 Determining the requirements for products and services

The requirements related to the services (stated/implied) as below, but not limited to:

Customer/Market needs
Cost involved
Statutory & regulatory requirements
Reference to the international standard
Organizational codes of Practice
Organizational policies & Objectives
Organizational capability
Relevant similar past experience in new product/service launching
Source of purchase
Mode of transportation
Present storage, handling & delivery methods,
Present over heads
Storage reliability
Suppliers reliability
Product/Service reliability
Competitors Product/Service
Competency of personnel
Inspection requirements
Anticipated market requirements
Inventory cost
Identification & Traceability
Product specifications
Stages of inspection and requirement
Reports of qualification tests
Transport requirement
Post-delivery activities

8.2.3 Review of the requirements for product and services

XXX shall review the requirements related to the contract and service prior to the commitment to supply to the client by reviewing the requirements from the client. The review is carried out by the respective section manager(s) and the relevant engineers who determines if the service can be provided or not. In case of tenders the “Estimation department” ensures that all the requirements are adequately reviewed.

Requirements related to the client are also identified clearly at the tendering process itself. The scope of work and the project deliverables clearly indicates the needs of the client. The specifications and instructions that accompany the tender documents are clear in identifying the requirements of the client related to the contract.

Clarifications and further information is received through the pre-tender meetings, or discussions and meetings with the client, visits to the site or proposed site areas, etc. Document and records which are controlled during the contract period are as follows:

Tender documents
Authorisation for pricing
Order transfer note
Progress report
Supplier quotation
Quotation to customer
Job card
QA/QC documents
Estimation sheets
Order receipt
Customer and contract document
Intermediate completion of services
Customer product / data sheet
Contract review comments and communicate the same

The review requirements of the products are done as per the following table

S. No	Requirement	Responsibility
1	Market feasibility	G.M. / Section Manager
2	Statutory and regulatory requirements	G.M./PRO
3	Raw material quality	QC Manager
4	Design mix	QC Manager
5	Equipment & Maintenance	G.M./Section Manager
6	Road signage	Section manager

The Procedure for contract Review (PR 024) is maintained which describes the process in details.

Ref: Contract Review (PR 024)

8.2.4 Changes to requirements for products and services

In situations where the client is not providing any documented statement of their requirement, the standard specification of the product is confirmed before making final commitment. Where contract requirements are changed, it is ensured that the relevant documentation is amended and relevant personnel are made aware of the changed requirements. Records of review are maintained by the sections.

When changes are required existing QMS, the management representative shall ensure through review the purpose and potential consequences of the change and its suitability and integrity with the existing management system. In case of need for availability of resources or need for the allocation or reallocation of responsibilities and authorities for the changes in the Objectives, it shall be duly addressed prior to formalizing the objectives. Management programs, identified risk control measures and action plans are amended, if required. If necessary, planning is also carried out through management review meetings. Regarding management of change (MOC) the organization shall identify the Risks associated with changes in the organization, Quality management system, or its activities, prior to the introduction of the changes. The organization also ensures that the results of these assessments are considered for determining the appropriate controls. These activities are further defined in the procedure Management of Change (PR 021)

Ref: Management of change (PR 021)

8.3 Design and development of products and services

8.3.1 General

XXX shall determine all the requirements of design of the products and services to fulfil products requirements and meet the entire satisfaction of customer. Required processes have been established and carried out the design and development as per the design and development procedure (PR 017). Although, the development shall not be restricted to this procedures because development and research always looks for better improvement of products in order to exceed the customer satisfaction.

8.3.2 Design and development planning

XXX prepare the plan and control the design for the development of products and services. The design engineer verifies the customer requirements prepare the effective plan for the proper designing. The design and development stages are clearly defined. The design and development stages are reviewed, verified and validated to ensure the requirements of the products have been meet with the requirements. The design engineer shall be responsible for the planning of design processes. The process owner shall review, verify and approval the design and development stages. Any risk and opportunities arising out of the design and development are managed as per the procedure of Risk assessment (PR 002).

These activities are further defined in the procedure Contract Review (PR 024)

Ref: Contract Review (PR 024)

8.3.3 Design and development inputs

The inputs of design and development of the products requirements are determined by the design engineer. The inputs are maintained as per the documentation requirements including the functional and performance requirements, environment and safety condition and output of the risk and Opportunity Process. Also XXX determines the information of previous design of delivered products and takes as a feedback to develop forthcoming products in the better way.

8.3.4 Design and development controls

Design and development review:

While designing the products and services, at suitable stages systematic reviews of design and development are performed in accordance with planned arrangements. Reviews status and comments are clearly marked and documented to give feedback and proposal to take necessary actions to meet the products requirements.

Design and development verification

Design verifications are carried out according to the plans and records of the verifications are maintained. It has been ensured that design and development outputs have met the design and development input requirements.

Design and development validation

The production engineer shall do validation of design and development as per the planned arrangements to ensure that resulting products are qualified and capable of meeting the requirements for the specified application and intended use. Validation is done prior to final use or delivers to customer. As necessary the customer also can validate the design and development.

8.3.5 Design and development outputs

The output of design and development is verified against the design and development input and approved prior to release. The output of design and development shall meet the input requirements. Instructions for the productions, information required for the purchasing of materials required for the products, as well as storage and handling information are also provided. Design outputs are in a format that will furnish all information required for the end user.

8.3.6 Design and development changes

The products and services designed and developed on the basis requirements and ready for the intended use. If the changes are required by the client, clear information for the required changes is received, and design engineer reviews and verifies the changes. Prior to implementation the changes are reviewed, verified, validated and approved. The changes records are documented and will be part of the contractual documents. Where required, design and development stages are detailed in the project quality plans and procedures issued by XXX. Various forms are design for the entire design and development process to keep as quality records.

Ref: Design and development procedure (PR 017).

8.4 Control of externally provided products and services

8.4.1 General

XXX has established a system to demonstrate its commitment and method through following section on its commitment and method for purchasing process, purchasing information and verification of purchased products.

8.4.2 Type and extend of control

Purchasing documents clearly and completely describe ordered products, including quality requirements. Purchasing documents are reviewed and approved prior to release. Purchased products are verified before they are used or delivered to end users. Details of purchasing process are documented in the procedure for control of externally provided services (PR 008). All new suppliers are evaluated with regard to their quality and process capability. All potential suppliers are evaluated based on the criteria of Quality and process as documented in the (PR 008). Supplier evaluation & re-evaluation is done in order to introduce them in the approved supplier list. The General Manager and the Management Representative establish the criteria for selection of suppliers, and purchasing staffs conduct supplier evaluation.

All potential suppliers are evaluated at least once in a year based on the criteria of Quality and process are documented in the procedure for Purchasing (PR 008) and once approved records are maintained in Approved supplier list.

XXX extend the control over supplier and outsourced processes and to the purchased products through the procedure for control of externally provided services (PR 008). The type and extent of controls will depend on the risk and opportunity associated with the product or service purchase. Quality performance of suppliers are monitored. Suppliers showing inadequate performance may be asked to implement corrective actions, and be downgraded or discontinued. In case there are identified risks of goods, equipment and services purchased, the controls are identified and if required communicated to the supplier or sub-contractor. Purchased products are inspected by requestor or the relevant managers. This includes verification of product identity and quantity, visual inspection and, where applicable, verification that all requested certificates and quality records are available. Record of the inspection are maintained.

Review also ensures that the purchased product meets the specified requirements. When deviations are identified, the supplier is contacted to discuss the corrective action. Where specialized services are required and have to be outsourced, the suppliers of such services are also identified, selected and approved in a manner similar to that mentioned above. Same controls are established for such activities.

Ref: Control of externally provided services procedure (PR 008).

8.4.3 Information for external providers

Purchasing documents are prepared by the purchasing in charge. The documents clearly and completely describe ordered products, including precise product identification and quality requirements. The General Manager or his appointed deputy reviews and approves all purchasing documents prior to release. Purchasing documents may be in the form of fax, e-mail, or other documented communication sent to the supplier, these clearly specify the requirements, specifications, terms and conditions. The document also includes the requirements for approval of product, procedures to follow (if applicable), requirements for qualification of personnel (where applicable) and Quality management system requirements. The documents are reviewed for adequacy of specified requirements and approved before sending to the supplier. The requirements to be followed by the suppliers/contractors are communicated by purchasing section at the time of signing the contract or along with purchase orders.

The procurement in charge shall ensure that procurement process have adequately defined and applied criteria for the selection of contractors. The procurement in charge shall ensure that outsourced functions and processes are controlled. The procurement in charge shall ensure that its outsourcing arrangements are consistent with legal requirements and other requirements and with achieving the intended outcomes of the Quality management system. The type and degree of control to be applied to these functions and processes shall be defined within the Quality management system as per the nature of work outsourced.

Ref: Control of externally provided services procedure (PR 008).

8.5 Production and service provision

8.5.1 Control of production and service provision

XXX establish control procedures covering all areas of company like general working areas, project sites, contract/project management, manufacturing, installation etc. to make sure its activities are carried out under controlled conditions. Controlled conditions include the following (where applicable):

The availability of information that describes the characteristics of the products and services offered,
The availability of work instructions as necessary,
The availability of information that describes the characteristics of the project through timing plan and method statement,
The use of suitable equipment identified through resource planning,
The availability and use of monitoring and measuring equipment,
The implementation of monitoring and measurement, and
The implementation of product release, delivery, and post-delivery activities.

To ensure this, XXX have developed method statements/Work instructions as per relevant national and international standards to be followed by the clients or the projects. A standard method statement contains the details on how to ensure quality of the products, Quality services, resource requirements, safety for the safe working conditions, measurement and control of process in line with the requirements of the customer. The method of statement of works is prepared and submitted to the client, consultant or contractors for their approval prior to execute the production/projects.

However, these can be modified and customized in accordance with project specification. XXX can function as prime, joint venture, or subcontractor, according to clients’ preferences. The final customization is approved by the process owners and relevant engineers prior to sending out to the client for approval. XXX also has own production facility to manufacture. These are produced as per standard specifications and project requirements. The products are designed as per the standards , special needs of clients are determined & are built as per specifications of products.

QA/QC requirements

The project manager has the full authority to run the project according to the plan drawn up with the General Manager. Working procedures are laid down taking into consideration of the customer’s requirement and quality aspects. Coordination, follow up and checking is duties assigned to the site staff, and are assured by regular meetings at suitable intervals.

Plant & equipment maintenance:

Plants are regularly maintained as per manufacturer’s maintenance schedule and manual. Maintenance is done by the respective sections. Moving vehicles, equipment, machines & etc. are maintained by mechanical engineering workshop regularly as well as the respective foreman in the department. Other hardware and software are regularly checked & maintained by IT department. Section heads are responsible to ensure the adequacy of all plant and equipment under their possession. The equipment are listed and included in the service/maintenance schedule as per type of equipment and its requirements. Outsource requirements for the maintenance (for specialized equipment) are requested and done as per purchasing procedures and as defined in the 8.4 in this manual.

Measuring and monitoring equipment:

Requirements for measuring and monitoring equipment are determined by Production and Quality Assurance. This is in accordance with process control and product verification programs defined in product realization planning (refer to Section 8.1 of this manual).

Validation of processes for production & service provision:

Processes where the resulting output cannot be verified by subsequent measurement or monitoring are designated as special processes. The relevant section heads are tasked with the responsibility of handling special processes and to ensure that the process is controlled and validated prior to delivery to the client. Special processes are validated and controlled by applicable methods, equipment and personnel qualification, and work instructions and process procedures. The use of specific methods and procedures are resorted to as applicable. Special process records are established and maintained as appropriate. Depending on the control measures implemented, these records may include process qualification and validation reports, equipment qualification and maintenance records, inspections and tests, operator qualification and training records, and so forth. If there is need for revalidation, that is also considered and handled accordingly.

Welding is considered as a special process and where required validation and revalidation is done for these special processes and works done. Welding procedures is prepared as per relevant standards. Only qualified welders are allowed to do the special welding jobs. Their practical experiences and skills are considered to assign the job to them. Monitoring or inspection of welding activities is done by competent engineer designated by Section Head. Where required third party inspection and certificates for the same will be maintained. The consumables storage, weld repair will be carried out as per the work instructions approved for the specific projects. XXX utilizes some “special processes” where the result of the process cannot be verified by subsequent monitoring or measurement. The special processes in use and the methods of validation of each are defined in Procedure for Validation of process (PR 026)

Ref: Validation of process (PR 026)

8.5.2 Identification and traceability

Purchased products are identified with its names and unique number used as necessary. The identification is the same as, or is cross-referenced with, the designations used in drawings, specifications, bills of materials, Products list, Purchase orders, etc. Purchased products are identified by marking, labelling, or tagging the products or their packaging, or by identification of the area where the products are held or per-codes (as per our new program). During all stages of production, products are usually identified by work orders and other documents that accompany them through the production cycle. Parts and components may also be identified by labels or tags, or the containers in which they are held. Final products are identified by their name, which is labelled by tags on the products. Projects are identified by their project numbers. When required by contracts, laws and regulations, or voluntary standards traceability is implemented to the extent specified. Traceability may also be implemented for internal reasons, to facilitate corrective action. As required, traceability may apply to materials, components, parts, production processes, environmental conditions, inspection and testing, and personnel responsible for processing and verification of products. The scope of traceability is documented in product manufacturing specifications or the production work order. The documented procedure Identification & traceability (PR 027) defines these methods in detail.

Ref: Identification & traceability (PR 027)

8.5.3 Property belonging to customers or external providers

Materials, tools, moulds & etc. provided by customer for the processing of products are received and inspected, in the event such products fail to meet the inspection criteria, or are not suitable for any other reason, the same shall be reported to customer and records shall be maintained. Storage, handling, and preservation of customer’s materials follow the same procedures that apply to purchase products. Customer’s software, documents, and other intellectual property are protected to the same extend as would internal documents of similar content, unless there are contractual requirements for special measure to protect customer’s intellectual property. When specified in a contract, special handling instructions from customers will take precedent over the company’s standard procedures. Customers are contacted in the event of loss, damage, deterioration, or unsuitability of their products by the relevant engineers. Customer’s vehicles and personnel entering to our yard to collect products and services are managed. Traffic flow is controlled by flagmen. All the loading activities are done under surveillance of safety personnel in order to avoid any damages or loss to the customer’s vehicles and personnel. This activity is defined in greater detail in the Procedure Customers or External Providers property (PR 028)

Ref: Customer or External Providers property (PR 028)

8.5.4 Preservation

Preservation of product by XXX describes in the relevant procedures, the conformity of its product at every stage from receipt of raw materials to delivery to its intended destination. It includes the identification, handling, storage and protection of both the products and the constituents of the products in order to maintain the conformity requirements. The section heads are responsible for product handling and preservation, and that products are adequately protected during production and storage. Where required, storage, and holding areas are controlled by the section that brings in new stock or uses the area. Only products that are properly identified and that have passed required inspections are authorized to enter and leave the store area. Products with limited shelf life are identified with expiration dates. These perishable products are also rotated in the storeroom to ensure that the oldest product is used first. The documented procedure Preservation of products (PR 029) defines the methods for preservation of product.

Ref: Preservation of products (PR 029)

8.5.5 Post-delivery activities

XXX shall ensure that all the post-delivery activities associated with the products and services. In determining the extent of post-delivery activities that are required, the organization shall consider

Statutory and regulatory requirements
The potential undesired consequences associated with its products services
The nature, use and intended lifetime of its products and services
Customer requirements and feedbacks.

For road construction, projects completion and warrantee certificates is given upon completion of the works as per contract requirements. Such warrantee is subject to the defect on the workmanship and materials supplied by XXX to be rectified immediately. All other warrantees are subject to the contracts terms and conditions.

8.5.6 Control of changes

XXX shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. All the documented information’s regarding the changes and results of changes shall be retained by XXX, which shall also contain the details of the person(s) authoring the change and any necessary actions arising from the review. In case any change impacts the product or services, XXX shall notify the customer about the changes either through email or by calling telephonically. Corrective action shall be taken as per the procedure for Corrective Action (PR 006). Assessment of Risk and Opportunity shall be done as per Procedure Risk Assessment (PR 002). Processes are monitored and controlled through variety of approaches, activities and techniques. The system is designed to control:

Information, material and human input into the process;
Technology, tools and equipment used;
Process environment and performance; and
Process output.
Organization structure
Key or essential personnel
Critical providers
Design
Management system

Process change management is defined in the Procedure Management of change. Documents are changed in accordance with procedure Control of documented information.

Ref: Risk Assessment (PR 002); Corrective Action (PR 006) Management of change (PR 021); Control of documented information (PR 001).

8.6 Release of products and services

The release of the products and services shall be as per the planned arrangements and by a competent authority as per procedure of Product Release (PR 030). Where there is a release otherwise it shall be approved by the respective departmental authority or as applicable by the customer requirements.

No	Requirement	Releasing authority
1	Incoming Raw Material	QC / Requester
2	During Production Stages	QC / Process Owner
3	Finished products – Production	QC
4	Finished products – Site	QC/Engineer
5	Project Handover	Project Manager

Documented information (Records) related to the stages of the production process and communications related to the acceptance of the product/service by clients will be maintained. Evidence of conformity to product requirements with acceptance criteria will be maintained with the traceability to the person(s) authorizing the release.

All products are released for delivery only after all specified activities have been satisfactorily completed. Regular tests are carried out to ensure the consistency of quality; Lab verifications, plant trails are done in witness of authorities (MOE or consultant) and conformity of the product are obtained. The designs are certified by Ministry of Environment. Documents are changed in accordance with procedure Control of documented information. All products are released after the approval of the client.

Final site inspection is done by the Consultant and the client. If any deviations found during inspection are corrected on the spot or redone as per consultant or client recommendation. A guarantee period of 400 days or else specified in the contract for the materials and workmanship defect and rectification on immediate basis is defined in all road construction projects. Any rectification requested by client within guarantee period has been verified and carried out on immediate basis.

Ref: Release of Product (PR 030)

8.7 Control of non-conforming outputs

XXX have taken special care to ensure that the outputs which do not conform to the planned arrangement or as per the requirements are identified and controlled to prevent unintended use or delivery. The following methods shall be adopted when dealing with non-conforming outputs can be:

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

Non-conforming materials are identified and segregated from conforming materials to prevent unintended use or confusion and mixing with conforming materials. A system is established for identifying, controlling, handling and taking proper action on detected non-conformity. These methods are defined through the procedure for control of non-conforming outputs (PR 005).

Ref: Control of non-conforming output procedure (PR 005).

9 PERFORMANCE EVALUATION

9.1 Monitoring, measurement analysis and evaluation

9.1.1 General

The Integration of the whole measuring and improvement system will cover the required improvement processes needed to demonstrate conformity to product requirements, to ensure conformity of the Quality management system and to continually improve the effectiveness of the Quality management system.

Major processes include:

Sales, production and service
Inspection and testing
Purchasing
Control of non-conforming outputs
Internal auditing
Customer satisfaction
Corrective actions
Data analysis
Legal requirements and compliance
Objective achievement
Operational effectiveness
Performance

The effectiveness of the QMS, including the policy and objectives, is monitored by conducting internal audits, and operational reviews, and is measured by customer satisfaction and key performance indicators. The results from the monitoring and measurement shall be analysed and evaluated by the top management.

9.1.2 Customer satisfaction

Customer satisfaction is measured by collecting and analysing direct customer feedback, and by measuring secondary indicators of customer satisfaction. Customer satisfaction data is used by the top management to identify opportunities and priorities for improvement. The procedure of measuring Customer satisfaction has been established as per Procedure for Customer Satisfaction (PR 031). The process owners/department managers is responsible for developing suitable indicators of customer satisfaction, and for defining methods for collecting and analysing the pertinent information in their areas. Information and data pertaining to customer satisfaction are collected from several sources such as but not limited to:

On-going feedback from customers,
Surveys using customer satisfaction survey form at the completion of each project and orders,
Analysis of trends of customer satisfaction/complaints/safety reports issued by client,
Awards and recognitions,
Repeat customer rates, and market share,
Lost business analysis.

Results of customer satisfaction surveys and the perception of the customers is analysed by the management representative and presented during the management review meetings.

Ref: Customer Satisfaction (PR 031)

9.1.3 Analysis and evaluation

XXX collects, complies and analyses information and data required for evaluating the suitability and effectiveness of the management system and for identifying opportunities for continual improvement. Data and information available in records are compiled and analysed periodically to determine trends in the performance and effectiveness of the management system and to identify opportunities for improvement. The Management Representative is responsible for coordinating these activities and for reporting conclusions and trends to the top management. This is usually done within the framework of management reviews of the QMS. Following categories of information and data are recorded, compiled and analysed:

Quality performance and records of communication from employees.
Conformance to product/service requirements (Objectives)
Status of non-conforming products and areas of re-occurrence.
Action against non-conformances (including audits)
Characteristics and trend of processes and products
Supplier performance recorded in supplier re-Evaluation and evaluated for trends by purchasing dept.
Customer satisfaction levels – recorded in customer satisfaction survey form
Customer complaints –evaluated for trends.
Effectiveness of training – recorded in training record.
Effectiveness of Quality management system – recorded in audit observation sheet and evaluated for trends.
Analysis of shall be conducted as per the Procedure for Analysis of Data (PR 032)

Ref: Analysis of Data (PR 032)

9.2 Internal audit

9.2.1 Planning and scheduling

Management representative establishes an internal audit plan ensuring that every activity and area is audited at least once a year. Selected activities are audited more frequently, depending on their importance, risk and opportunities associated with the process, result performance evaluation of process, results of past audits and quality performance history. The audit criteria, scope, frequency and methods are defined in an internal audit plan which also lists the audit criteria, auditor, auditee, date, and time.

9.2.2 Audit team and preparation for audit

Only suitably trained and qualified personnel independent of the audited activities are assigned to conduct internal audits. A list of trained internal auditors is maintained by the Management Representative in list of trained internal auditors form. Also Management Representative can identify third part auditor to conduct internal audit as necessary. The qualified auditors from different sections may audit different section. Auditors prepare for audits by reviewing applicable standards and procedures, analyzing quality records, and establishing questionnaires and checklists.

Conducting the audit

Auditors seek objective evidence indicating whether the audited activities comply with the requirements of the documented QMS system, and whether the QMS system is effective. The evidence is collected by observing activities, interviewing personnel, and examining records. Findings are recorded on an audit observation sheet. Negative findings are reported as non-conformities and documented using non-compliance report form. Also the third party’s audit report also can be used to monitor and follow up for corrective actions. Audits are conducted in a way that minimizes disruption of the audited activities.

Corrective action and follow up

When nonconforming conditions are identified, the process owner for the affected area or process is requested to propose and implement a corrective action. Implementation and effectiveness of the action are verified by a follow-up audit. The non-compliance report form is used for monitoring and recording the implementation of the corrective actions. Non-compliance reports are closed out by the Management Representative after evaluating effectiveness of action taken. Where a non-compliance is raised against the activities of the Management Representative, only the General Manager is authorized to close out these reports.

Reporting

When the auditing cycle is completed, all nonconformity reports established during the cycle are compiled and analysed, and are presented at the management review meeting by the Management Representative. Internal audits aQMS to verify conformance of the planned arrangements to the requirements of the standards and to that of the Quality management system established.

Ref: Internal audit procedure (PR 004).

9.3 Management review

9.3.1 General

XXX reviews established QMS to ensure its suitability, adequacy and effectiveness which includes assessment for opportunities for improvement and the need for changes to the QMS as per the procedure for management review (PR 003).

Management review meeting is conducted at least once a year. The review committee consists of the following members and is chaired by the General Manager.

General manager (GM)
Assistant manager
Management representative (MR)
Document controller (DC)
All section heads/ managers
HSE
Any other special invitee

Method, duration, responsibility, authority, review input/output for the management review is defined through the procedure (PR003) for management review.

9.3.2 Management review inputs

Inputs for the period of review to management review meeting related to the process performance are prepared by the process owners & QUALITY representatives and the system related performances are provided by the management representative.

9.3.3 Management review outputs

The output of the meeting includes the decisions and actions related to the improvement of the effectiveness of the QMS. The minutes, after approval by the General Manager, is circulated to attendees and management representative for further review and discussion and following up the implementing the actions decided in the meeting. The outputs of the management review meeting shall include decisions and actions related to

Opportunities for improvement
Any need for changes to the QMS
Resource needs

The management representative shall maintain the documented information of the results of the review meeting.

Ref: Management review procedure (PR 003).

10 IMPROVEMENT

10.1 General

XXX has deployed continual improvement principle throughout the entire organization. The improvement effort is driven by goals defined in the policy and objectives. Improvement shall include:

Improving products and services to meet requirements as well as to address the future needs and expectations
Correcting, preventing or reducing undesired effects
Improving the performance and effectiveness of the Quality management system

Improvement opportunities are identified by analysing quality performance data and information. Improvement projects are defined and implemented through the system of corrective actions, and management review actions. Causes of identified non-conformities are investigated and, where appropriate, corrective actions are implemented to ensure that non-conformities do not recur. Corrective actions taken are recorded and are followed up to ensure that they have been properly implemented and that they are effective.

10.2 Non conformity and corrective action

Nonconforming products/ services are identified, documented, evaluated, and prevented from being used or delivered to the customer. Repaired or reworked products are re-inspected. Appropriate actions are taken when product nonconformity is identified after delivery. When appropriate, corrective actions are implemented to prevent recurrence of identified nonconformities.

Identification and documentation

XXX identifies and documents all product/ service nonconformities, regardless of how insignificant they seem to be or how easily they can be repaired or reworked. Product nonconformity records are invaluable for tracking performance and trends, and for identifying areas where corrective actions should be implemented.

During purchasing of materials or services or sub-contracting parts of the service, non-conforming products are segregated and reported to the supplier or sub-contractor for corrective actions.

Nonconforming products/ services are documented using a non-compliance report form. It describes the nonconformity, documents the disposition decision, and records close-out of follow-up activities (re-inspection, concessions, corrective actions, etc.). It is a company policy not to deliver nonconforming products/ services to clients and the responsibility for this rests with the Section heads.

Therefore no segregation/ tagging methods are required. Adherence to specifications including delivery times is of prime importance.

Nonconformity review and disposition:

Review of non-conforming products/ services are carried out with the sole intention of re-working and correcting the non-conformity, after which it is delivered to the customer. Under no circumstances, non-conforming products/ services are delivered intentionally to the customers.

Re-verification of repaired or reworked product:

Reworked products are re-inspected and their conformity with the requirements of the customer confirmed prior to delivery. This may also involve interaction with the client and obtaining their acceptance of the product/ service prior to delivery.

All such actions related to control of nonconforming products/ services are recorded in the relevant project files.

If product nonconformity is detected internally after delivery or use has started, customers are informed and instructed what to do with the product. In situations when the nonconformity may create a safety or other hazard, the product may be recalled. Only the General Manager or his appointed deputy is authorized to make recall decisions. Details of the process are available in control of non-conforming outputs (PR 005)

The need for corrective action is determined on the basis of identified actual non-conformities. Corrective action requests are typically triggered by such events as a failed inspection, customer complaint, deviation from work instruction/legal requirements/regulations, non-conforming delivery from a supplier, or a system audit finding. XXX has established a procedure for handling corrective actions as below, details of which are available in (PR 006):

Requirement for corrective actions are documented in a noncompliance report form where the nature of the non-compliance is recorded. The process owner identifies the proposed corrective action and sets reasonable time frames for implementation. After the due date, the management representative reviews the action taken and evaluates the effectiveness of the corrective action. The purpose of the corrective action is to:

Review the nonconformities including the customer complaints
Determining the root causes of the non-conformity
Taking action to eliminate the root cause of the problem to ensure that the non-conformity does not recur
Determining and implementing the action needed
Record the result of the actions taken
Reviewing and recording the effectiveness of the action taken

The management representative maintains records of all the corrective actions initiated analyses and reports trends periodically and during management review meetings.

Ref: Control of non-conforming procedure (PR 005), Corrective actions procedure (PR 006).

10.3 Continual improvement

XXX top management ensures the improvement in effective implementation and performance of the Quality management system by systematically reviewing and updating the QUALITY policy, quality objectives, analysing audit results and other data from monitoring and measurement relevant to quality, environment and safety performance, corrective action and the management review. System performance is evaluated by respective section managers and reported in the management reviews of the QMS. Where the performance falls short of a defined objective, the management review identifies specific improvement actions to reach the objective. When an objective is reached, the management review may set a new, higher objective in this area and specify new improvement actions for reaching it.

In addition to management reviews, process owners identify improvement opportunities continually, based on the feedback from their operations and other activities. Employees are also encouraged to come forward with ideas for improving products, processes, systems, productivity, and working environment. These improvement opportunities are evaluated and prioritized by the engineers and section managers and where appropriate they are implemented. Where additional plans and resources are required, these are discussed in the management reviews and approved sought from the management. Changes arising out of the Continual improvement shall be managed as per the Procedure Management of change (PR 021). The section managers shall collate the continual improvement done in there are and present in the continual improvement plan format as per the procedure for continual improvement (PR016)

Ref: Continual improvement procedure (PR 016).