Civilers Edge QA & QC,Quality management system Requirements of Quality Management System

Requirements of Quality Management System

Requirements of Quality Management System

Requirements of Quality Management System is depended on many requirements such as

  • The organization’s quality policy and quality objectives.
  • Quality manual.
  • Procedures, instructions, and records.
  • Data management.
  • Internal processes.
  • Customer satisfaction from product quality.
  • Improvement opportunities.
  • Quality analysis.

Hello Everyone, Welcome back to Civilers Edge.

In my last post on Quality Management System in Construction as I said a quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. The purpose of a quality management system is to ensure every time a process is performed, the same information, methods, skills and controls are used and applied in a consistent manner. If there are process issues or opportunities, this is then fed into the quality management system to ensure continuous improvement. I have explained the Scope and Importance of Quality Management System requirements.

Requirements of Quality Management System

5.4 Planning

Requirements of Quality Management System
Requirements of Quality Management System

5.4.1 Quality Objective

Top management shall ensure that quality objectives, including those needed to meet requirements for the product,) are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy,

5.4.2 Quality management system planning

Top management shall ensure that

  • the planning of the quality management system is carried out in order to meet the requirements given in as well as the quality objectives, and
  • the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

5.5 Responsibility, authority and communication

authority vs responsibility1
Responsibility and Authority

5.5.1 Responsibility and authority

Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.

5.5.2 Management representative

Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes

  • ensuring that processes flooded to the quality management system are established, implemented and maintained
  • reporting to top management on the performance of the quality management system and any need for improvement, and
  • ensuring the promotion of awareness of customer requirements throughout the organization.

NOTE:  The responsibility of a management representative can include liaison with    external parties on matters relating to the quality management system

5.5.3 Internet Communication

Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system

5.6 Requirements of Quality Management System – Management review

5.6.1 General

Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

Records form of management review shall be maintained.

5.6.2 Review input

The input to the management review shall include information

  • results of audits,
  • customer feedback,
  • process performance and product conformity,
  • status of preventive and corrective actions
  •  follow-up actions from  previous management reviews,
  • Changes that could affect the quality management system, and
  • recommend for improvement,

5.6.3 Review output

The output from the management review shall include any decisions and actions related to

  • improvement of the effectiveness of the quality management system and its processes,
  • Improvement of product related to customer requirements, and resource needs,

6. Resource management

Resource Management
Resource Management

6.1 Provision of resource

The organization shall 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 requirements.

6.2 Human resources

6.2.1 General

Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

6.2.2 Competence, awareness and training

The organization shall

  • determine the necessary competence for personnel performing work affecting product quality,
  • provide training or take other actions to satisfy these needs,
  • evaluate the effectiveness of the actions taken,
  • ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and ,
  • maintain appropriate records of education, training, skills and experience.

6.3 Requirements of Quality Management System – Infrastructure

The organization shall determine, provide and maintain the infrastructure  needed to achieve conformity to product requirements, infrastructure includes, as applicable

  • buildings, workspace and associated utilities,
  • process equipment (both hardware and software), and
  • supporting services (such as transport or communication).

6.4 Work environment

The organization shall determine and manage the work environment needed to achieve conformity to product requirements.

7. Requirements of Quality Management System – Product realization

7.1 Planning of Product Realization

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirement of the other processes of the quality management system.

In planning product realization, the organization shall determine the following, as appropriate:

  • Quality objectives and requirements for the product
  • the need to establish processes, and documents, and provide resources specific to the product.
  • required verification, validation, monitoring, inspection end test activities specific to the product and criteria for product acceptance;
  • records needed to provide evidence that the realization processes and resulting product meet requirements 
  • The output of this planning shall be in a form suitable for the organization’s method of operations.

NOTE 1 : A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.

NOTE 2: The organization may also apply the requirement given in 7.3 to the development of the product realization process.

7.2 Customer-related processes

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Customer Related Processes

7.2.1 Determination of requirements related to the product

The organization shall determine

  • requirements specified by the customer, including the requirements for delivery and post-delivery activities,
  • requirements not stated by the customer but necessary for specified or intended use, where known,
  • statutory and regulatory requirements related to the product, and
  • any additional requirements determined by the organization.

7.2.2 Review of requirements related to the product

The organization shall review the requirements related to the product. This review shall be conducted prior to the organization’s commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that

  • product requirements are defined,
  • contract or order requirements differing from those previously expressed are resolved, and
  • the organization has the ability to meet the defined requirements.
  • Records of the results of the review and actions arising from the review shall be maintained.
  • Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel is made aware of the changed requirements.

NOTE: In some situations, such as Internet sales, a formal review is impractical for each order, Instead the review can cover relevant product information such as catalogs or advertising materials.

7.2.3 Customer Communication

The organization shall determine and implement effective arrangements for communicating with customers in relation to

  • product information,
  • inquiries, contracts or order handling, including amendments, and
  • customer feedback, including customer complaints.

7.3 Design and Development

7.3.1 Design and Development planning

  • The organization shall plan and control the design and development of the product.
  • During the design and development planning, the organization shall determine
  • the design and development stages,
  • the review, verification and validation that are appropriate to each design  end development stage, and
  • the responsibilities and authorities for design and development.
  • The organization shall manage the interfaces between different groups involved In design and development to ensure effective communication and clear assignment of responsibility.
  • Planning output shall be updated, as appropriate, as the design and development progress.

7.3.3 Design and development outputs

The outputs of the design and development shall be provided in a term that enables verification against the design and development input and shall be approved prior to release.

  • Design and development outputs shall
  • meet the input requirements for design and development.
  • provide appropriate information for purchasing, production and for service provision
  • contain or reference product acceptance criteria, and
  • specify the characteristics and the product that is essential for Its sale and proper use. 

7.3.4 Design and development review

At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements

  • to evaluate the ability of the results of design and development to meet requirements, and
  • to identify any problems and propose necessary actions.
  • Participants in such reviews shell Include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained.

7.3.5 Design and development verification

Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained.

7.3.6 Design and development Validation

Design and development validation shall be performed in accordance with planned arrangements

to ensure that the resulting product is capable of meeting the requirements for the specified applications or intended use, where known. Whoever practicable validation shall be completed prior to the delivery or implementation of the product,, Records of the results of validation and any necessary actions shall be maintained.

7.3.7 Control of design and development changes

Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated as appropriate, and approved before implementation. The review of design and development changes shall include an evaluation of the effect of the changes on constituent parts and products already delivered.

Records of the results of the review of changes and any necessary actions shall be maintained.

7. 7.4.1 Purchasing process

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Purchasing Process

The organization shall ensure that the purchased product conforms to specified to purchase requirements, The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.

The organization shall evaluate and select suppliers based on their ability to supply products In accordance with the organization’s requirements. Criteria for selection evaluation and re-evaluation shall be established. Records of the results of the evaluation and any necessary actions arising from the evaluation shall be maintained.

7.4.2 Purchasing information

Purchasing information shall describe the product to be purchased, including where appropriate

  • requirements for approval of product, procedures, processes and equipment,
  • requirements for qualification of personnel, and 
  • quality management system requirements.

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier,4 Purchasing

7.4.3 Verification of Purchased product

The organization shall establish and implement the inspection or other activities necessary for ensuring that the purchased products meet specified purchase requirements.

Where the organization or its customer intends to perform verification at the Suppliers’ promises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.

7.5 Production and service provision

7.5.1 Control of production and service provision

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable..

  • the availability of information that describes the characteristics of the product,
  • the availability of work instructions, as necessary,
  • the use of Suitable equipment,
  • the availability and use of monitoring and measuring devices,
  • the implementation of monitoring and measurement and
  • the implementation of release, delivery and post-delivery activities.

7.5.2 Validation of processes for production and service provision

The organization shall  validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become  apparent only after the  product is in use or the service has been delivered.

  • Validation shall demonstrate the ability of these processes to achieve planned results.
  • The organization shall establish arrangements for these processes including as applicable.
  • Defined criteria  for review and approval of the processes,
  • approval of equipment and qualification of personnel,
  • use of specific methods and procedures,
  • requirements for records (see 4.2.4), and
  • revalidation.

7.5.3  identification and tractability

Where appropriate, the organization shall identify the product by suitable means throughout product realization. 

The organization shall identify the product’s status with respect to monitoring and measurement requirements.

Where tractability is a requirement, the organization shall control and records the unique identification of the product.

NOTE : In some industry sectors. Configuration management is a means by which identification and traceability are maintained.

7.5.4 Customer property

The organization shall exercise care with customer property while it Is under the organization’s control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product, It any Customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained.

NOTE: Customer property can Include intellectual property.

7.5.5 Preservation of product

The organization shall preserve the conformity of the product during internal processing and delivery to the intended destination. This preservation shell Includes identification. handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.

7.6 Control of monitoring and measuring devices

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of the product to determined requirements.

The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

Where necessary to ensure valid results, measuring equipment shall

  • be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded.
  • be adjusted or readjusted as necessary;
  • be identified to enable the calibration status to be determined:
  • be safeguarded from adjustments that would invalidate the measurement result;
  • be protected from damage and deterioration during handling, maintenance and storage.

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained.

When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.

8. Measurement, Analysis and Improvement

8.1. General

The organization shall plan and implement the monitoring, measuring, analysis and Improvement processes needed.

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

This shall include the determination of applicable methods, including statistical techniques, and the extent of their use.

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.

8.2.2 internal audit

The organization shall conduct internal audits at planned intervals to determine whether the quality management system

Conforms to the planned arrangement to the requirements of this International Standard and to the quality management system requirements established by the organization and

is effectively implemented and maintained.

An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process Auditors shall not audit their own work.

The responsibility and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined In documented procedure.

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformity and its causes.  Follow-up activities shall include the verification of the action taken and the reporting of the verification result (see 8.5.2).

8.2.3 Monitoring and measurement of processes

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.

8.2.4 Monitoring and measuring of product

The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements.

Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing the release of the product.

Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by the relevant authority and, where applicable, by the customer.

8.2.3 Monitoring and measurement of processes

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.

8.2.4 Monitoring and measuring of product

The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements.

Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing the release of the product.

Product release and service delivery shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by the relevant authority and, where applicable, by the customer.

8.3 Control of nonconforming product

The organization shall ensure that product which does not conform to product requirements is identified end controlled to prevent their unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming products shall be defined in a documental procedure.

The organization shall deal with the nonconforming product by one or more of the following ways;

  • by taking action to eliminate the detected nonconformity;
  • by authorizing Its use, release, or acceptance under concession by a relevant authority and, where applicable, by the Customer.
  • by taking action to include its original intended use of the application.

Records of the nature of nonconformity and any subsequent action taken, including concessions obtained shall be maintained.

When a nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.

When a nonconforming product is detected after delivery or use has started, the organization shall be taken action appropriate to the effect, or potential effects, of the nonconformity.

8.4 Analysis of data

The Organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.

The analysis of data shall provide information relating to

  • customer satisfaction, 
  • conformity to product requirements,
  • characteristics and trends of processes and products including opportunities for preventive action, and
  • suppliers.

8.5 Improvement

8.5.1 Continual improvement

The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

8.5.2 Corrective action

The organization shall be taken action to eliminate the cause of nonconformities in order to prevent a recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered.

A documented procedure shall be established to define the requirements for

  • reviewing nonconformities  (Including customer complaints)
  • determining the causes of nonconformities
  • evaluating the need for action to ensure that nonconformities do not recur,
  • determination and implementing action needed,
  • records of the results of action taking (see 4.2.4), and
  • Review corrective action taken.

8.5.3 Preventive action

The organization shall determine the action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effect of the potential problems.

A documented procedure shall be established to define requirements for

  • determining potential nonconformities  and their causes,
  • evaluating the need for action to prevent the occurrence of non-conformities,
  • determining and implementing  action needed,
  • records of results of action taken, and
  • reviewing preventive action taken.

So friends in my two posts on QMS I have tried to explain in detail about the QMS procedure. If you have any doubts please comment and let me know.

See you all with a new topic…

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