4 Quality Management System (Back to Top)
4.1 General Requirements
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
The organization shall:
a) identify the processes needed for the quality management system and their application throughout the organization (see1.2)
b) determine the sequence and interaction of these processes
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
e) monitor, measure and analyze these processes and
f) implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this international standard.
Where an organization chooses to out-sources any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such out-sourced processes shall be identified within the quality management system.
Note: Processes needed for the quality management system referred to above should included processes for management activities, provision of resources, product realization and measurement.
4.2 Document Requirements (Back to Top)
The quality management system documentation shall include:
a) documented statements of a quality policy and quality objectives
b) a quality manual
c) documented procedures required by this international standard
d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and
e) records required by this international standard (see 4.2.4)
Note 1 Where the term "documented procedure" appears within this international standard this means that the procedure is established, documented, implemented and maintained.
Note 2 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of organization and type of activities
b) the complexity of processes and their interactions, and
c) the competence of personnel.
Note 3 The documentation can be in any form or type of medium.
4.2.2 Quality manual (Back to Top)
The organization shall establish and maintain a quality manual that includes:
a) the scope of the quality management system, including details of and justification for exclusions (see 1.2)
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.
4.2.3 Control of Documents (Back to Top)
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed:
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents
c) to ensure that changes and the current revision status of documents are identified, to ensure that relevant versions of applicable documents are available at points of use,
d) to ensure that documents remain legible and readily identifiable
e) to ensure that documents of external origin are identified and their distribution controlled and
f) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose
4.2.4 Control of Records (Back to Top)
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection,, retrieval, retention time and disposition of records.
5 Management Responsibility (Back to Top)
5.1 Management commitment
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements;
b) establishing the quality policy
c) ensuring that quality objectives are established;
d) conducting management reviews and
e) ensuring the availability of resources.
5.2 Customer focus (Back to Top)
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1)
5.3 Quality policy (Back to Top)
Top management shall ensure the quality policy
a) is appropriate to the purpose of the organization;
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system;
c) provides a framework for establishing and reviewing quality objectives
d) is communicated and understood within the organization and
e) is reviewed for continuing suitability.
5.4 Planning (Back to Top)
5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1 a) 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 (Back to Top)
Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1 as well as the quality objectives and
b) 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 (Back to Top)
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 (Back to Top)
Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes
a) ensuring that processes needed for the quality management system are established, implemented and maintained.
b) Reporting to top management on the performance of the quality management system and any need for improvement and
c) 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 Internal communication (Back to Top)
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 Management Review (Back to Top)
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.
5.6.2 Review input (Back to Top)
The input to management reviews shall include information on:
a) results of audits
b) customer feedback
c) process performance and product conformity
d) status of preventive and corrective actions
e) follow-up actions from previous management reviews
f) changes that could affect the quality management system and
g) recommendations for improvement.
5.6.3 Review output (Back to Top)
The output from the management review shall include any decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements and
c) resource needs.
6 Resource Management (Back to Top)
6.1 Provision of resources
The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness and
b) to enhance customer satisfaction by meeting customer requirements;
6.2 Human Resources (Back to Top)
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 (Back to Top)
The organization shall
a) determine the necessary competence for personnel performing work affecting product quality.
b) Provide training or take other actions to satisfy these needs;
c) Evaluate the effectiveness of the actions taken,
d) 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
e) Maintain appropriate records of education, training, skills, and experience (see 4.2.4)
6.3 Infrastructure (Back to Top)
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes as applicable;
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software) and
c) supporting services (such as transport or communication)
6.4 Work environment (Back to Top)
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
7 Product Realization (Back to Top)
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 requirements of the other processes of the quality management system (see 4.1)
In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements of the product;
b) the need to establish processes, documents, and provide resources specific to the product;
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)
The output of this planning shall be in a form suitable for the organization's method of operations.
Note 1 A documented 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 requirements given in 7.3 to the development of product realization processes.
7.2 Customer-related processes (Back to Top)
7.2.1 Determination of requirements related to the product
The organization shall determine
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities;
b) requirements not stated by the customer but necessary for specified or unintended use, where known.;
c) statutory and regulatory requirements related to the product and
d) any additional requirements determined by the organization.
7.2.2 Review of requirements related to the product (Back to Top)
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:
a) product requirements are defined
b) contract or order requirements differing from those previously expressed are resolved and
c) the organization has the ability and actions arising from the review shall be maintained (see 4.2.4)
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
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 are 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 catalogues or advertising material.
7.2.3 Customer communication (Back to Top)
The organization shall determine and implement effective arrangements for communicating with the customer in relation to
a) product information
b) inquiries, contracts or order handling, including amendments and
c) customer feedback, including customer complaints.
7.3 Design and Development (Back to Top)
7.3.1 Design and development planning
The organization shall plan and control the design and development of product.
During the design and development planning, the organization shall determine
a) the design and development stages
b) the review, verification and validation that are appropriate to each design and development stage, and
c) 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 progresses.
7.3.2 Design and development inputs (Back to Top)
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include
a) functional and performance requirements
b) applicable statutory and regulatory requirements
c) where applicable, information derived from previous similar designs, and
d) other requirements essential for design and development.
These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.
7.3.3 Design and development outputs (Back to Top)
The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.
Design and development outputs shall
a) meet the input requirements for design and development
b) provide appropriate information for purchasing, production and for service provision
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential for its safe and proper use.
7.3.4 Design and development review (Back to Top)
At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)
a) to evaluate the ability of the results of design and development to meet requirements and
b) to identify any problems and propose necessary actions.
Participants in such reviews shall include representatives of functions concerned with the design and development stage (s) being reviewed. Records of the results of the review and any necessary actions shall be maintained (see 4.2.4).
7.3.5 Design and development verification (Back to Top)
Verification shall be performed in accordance with planned arrangements (see 7.3.1) 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 action shall be maintained (see 4.2.4).
7.3.6 Design and development validation (Back to Top)
Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever 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 (see 4.2.4).
7.3.7 Control of design and development changes (Back to Top)
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 evaluation of the evaluation of the effect of the changes on constituent parts and product already delivered.
Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).
7.4 Purchasing (Back to Top)
7.4.1 Purchasing process
The organization shall ensure that purchased product conforms to specified 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 product in accordance with the organization's requirements. Criteria for selection, evaluation and the re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).
7.4.2 Purchasing information (Back to Top)
Purchasing information shall describe the product to be purchasing, including where appropriate
a) requirements for approval of product, procedures, processes and equipment
b) requirements for qualification of personnel and
c) quality management system requirements
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the suppliers.
7.4.3 Verification of purchased product (Back to Top)
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
7.5 Production and service provision (Back to Top)
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.
a) the availability of information that describes the characteristics of the product
b) the availability of work instructions, as necessary
c) the use of suitable equipment
d) the availability and use of monitoring and measuring devices
e) the implementation of monitoring and measurement, and
f) the implementation of release, delivery and post-delivery activities.
7.5.2 Validation of processes for production and service provision (Back to Top)
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
a) defined criteria for review and approval of the processes
b) approval of equipment and qualification of personnel
c) use of specific methods and procedures
d) requirements for records (see 4.2.4), and
7.5.3 Identification and traceability (Back to Top)
Where appropriate, the organization shall identify the product by suitable means throughout product realization.
The organization shall identify the product status with respect to monitoring and measurement requirements.
Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).
Note In some industry sectors, configuration management is a means by which identification and traceability are maintained.
7.5.4 Customer property (Back to Top)
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 in or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).
Note: Customer property can include intellectual property.
7.5.5 Preservation of product (Back to Top)
The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include 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. (Back to Top)
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).
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
a) 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;
b) be adjusted or re-adjusted as necessary
c) be identified to enable the calibration status to be determined;
d) be safeguarded from adjustments that would invalidate the measurement result
e) 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 (see 4.2.4).
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.
Note See ISO 10012-1 and ISO 10012-2 for guidance.
8 Measurement, analysis and improvement (Back to Top)
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
a) to demonstrate conformity of the product,
b) to ensure conformity of the quality management system
c) to continually improve the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
8.2 Monitoring and measurement (Back to Top)
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 (Back to Top)
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangements (see 7.1) to the requirements of this international standard and to the quality management system requirements established by the organization, and
b) 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 auditor and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditor 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 a documented procedure.
The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected non-conformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).
Note See ISO 10011-11, ISO 10011-2 and ISO 10011-3 for guidance.
8.2.3 Monitoring and measurement of processes (Back to Top)
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 measurement of product (Back to Top)
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 (see 7.1).
Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person (s) authorizing release of product (see 4.2.4).
Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.
8.3 Control of nonconforming product (Back to Top)
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
The organization shall deal with nonconforming product by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;
c) by taking action to preclude its original intended use or application.
Records of the nature of non-conformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).
When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.
When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.
8.4 Analysis of data (Back to Top)
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
a) customer satisfaction (see 8.2.1)
b) conformity to product requirements (see 7.2.1),
c) characteristics and trends of processes and products including opportunities for preventive action and
8.5 Improvement (Back to Top)
8.5.1 Continuous 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 reviews.
8.5.2 Corrective action (Back to Top)
The organization shall take action to eliminate the cause of non-conformities in order to prevent recurrence. Corrective action shall be appropriate to the effects of the non-conformities encountered.
A documented procedure shall be established to define the requirements for:
a) reviewing non-conformities (including customer complaints),
b) determining the causes of non-conformities
c) evaluating the need for action to ensure that non-conformities do not recur
d) determining and implementing action needed
e) records of the results of action taken (see 4.2.4) and
f) reviewing corrective action taken.
8.5.3 Preventive action (Back to Top)
The organization shall determine action to eliminate the causes of potential non-conformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.
A documented procedure shall be established to define responsibility for
a) determining potential non-conformities and their causes
b) evaluating the need for action to prevent occurrence of non-conformities
c) determining and implementing action needed
d) records of results of action taken (see 4.2.4) and
e) reviewing preventive action taken.