10.2 Nonconformity and corrective action (10.2.2)

10. IMPROVEMENT

10.2 Nonconformity and corrective action

10.2.2 Retain documented information

The organization shall retain documented information as evidence of:

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

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9.3 Management Review (9.3.3)

9. PERFORMANCE EVALUATION

9.3 Management Review

9.3.3 Management Review Outputs

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

• a) opportunities for improvement;
• b) any need for changes to the quality management system;
• c) resource needs.

The organization shall retain documented information as evidence of the results of management reviews


Cross Reference
Clause 10.3 (Continual Improvement)

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9.2 Internal Audit (9.2.2)

9. PERFORMANCE EVALUATION

9.2 Internal Audit

9.2.2

organization shall;

• a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits;
• b) define the audit criteria and scope for each audit;
• c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;
• d) ensure that the results of the audits are reported to relevant management;
• e) take appropriate correction and corrective actions without undue delay
• f) retain documented information as evidence of the implementation of the audit programme and the audit results.

NOTE See ISO 19011 for guidance.

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9.1 Monitoring, measurement, analysis and evaluation (9.1.1)

9. PERFORMANCE EVALUATION

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

The organization shall determine:

• a) what needs to be monitored and measured;
• b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results;
• c) when the monitoring and measuring shall be performed;
• d) when the results from monitoring and measurement shall be analysed and evaluated.

The organization shall evaluate the performance and the effectiveness of the quality management system.

The organization shall retain appropriate documented information as evidence of the results.

Cross reference
Clause 4.4.1 (QMS and its processes)
Clause 9.1.3 (Performance analysis and evaluation)
Clause 10.1 (Improvement)

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8.7 Control of nonconforming outputs (8.7.2)

8. OPERATION

8.7 Control of nonconforming outputs

8.7.2

The organization shall retain documented information that:

• a) describes the nonconformity;
• b) describes the actions taken;
• c) describes any concessions obtained;
• d) identifies the authority deciding the action in respect of the nonconformity

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8.6 Release of products and services

8. OPERATION

8.6 Release of products and services

The organization shall implement planned arrangements, at appropriate stages, to verify that the products and services requirements have been met.

The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.

The organization shall retain documented information on the release of products and services. The documented information shall include:

• a) evidence of conformity with the acceptance criteria;
• b) traceability to the person(s) authorizing the release.

Cross reference
Clause 8.5.1 (Process control)
Clause 9.1.3 (Performance analysis and evaluation)

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8.5 Production and service Provision (8.5.6)

8. OPERATION

8.5 Production and service Provision

8.5.6 Control of changes

The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.

The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.


Cross reference
Clause 4.4.1 (QMS and its processes)

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8.5 Production and service Provision (8.5.3)

8. OPERATION

8.5 Production and service Provision

8.5.3 Property belonging to customers or external providers

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

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

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

NOTE A customer’s or external provider’s property can include material, components, tools and equipment, premises, intellectual property and personal data.

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8.5 Production and service Provision (8.5.2)

8. OPERATION

8.5 Production and service Provision

8.5.2 Identification & traceability

The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.

The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.

The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability.

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8.5 Production and service Provision (8.5.1)

8. OPERATION

8.5 Production and service Provision

8.5.1 Control of production and service provision

The organization shall implement production and service provision under controlled conditions.

Controlled conditions shall include, as applicable:

• a) the availability of documented information that defines: (via 8.1 & 8.2.2)
• 1) the characteristics of the products to be produced, the services to be provided, or the activities
• 2) be performed;
• 3) the results to be achieved;
• b) the availability and use of suitable monitoring and measuring resources (via 7.1.5);
• c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met; (via 8.2.3)
• d) the use of suitable infrastructure (via 7.1.3) and environment for the operation of processes via 7.1.4);
• e) the appointment of competent persons (via 7.2), including any required qualification;
• f) the validation , and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement ;
• g) the implementation of actions to prevent human error;
• h) the implementation of release (via 8.6), delivery and post-delivery activities (via 8.5.5).

Cross reference
Clause 4.4.1 (QMS and its processes)
Clause 9.1.3 (Performance analysis and evaluation)
Clause 10.1 (Improvement)

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8.4 Control of externally provided processes, products and services (8.4.1)

8. OPERATION

8.4 Control of externally provided processes, products and services

8.4.1 General

The organization shall ensure that externally provided processes, products and services conform to requirements.

The organization shall determine the controls to be applied to externally provided processes, products and services when:

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

The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements.

The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.

Cross reference
Clause 9.1.3 (Performance analysis and evaluation) 

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8.3 Design and development of products and services (8.3.6)

8. OPERATION

8.3 Design and development of products and services

8.3.6 Design and development changes

The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.

The organization shall retain documented information on:

• a) design and development changes;
• b) the results of reviews;
• c) the authorization of the changes;
• d) the actions taken to prevent adverse impacts.

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8.3 Design and development of products and services (8.3.5)

8. OPERATION

8.3 Design and development of products and services

8.3.5 Design and development outputs

The organization shall ensure that design and development outputs:

• a) meet the input requirements;
• b) are adequate for the subsequent processes for the provision of products and services;
• c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;
• d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

The organization shall retain documented information on design and development outputs.

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8.3 Design and development of products and services (8.3.4)

8. OPERATION

8.3 Design and development of products and services

8.3.4 Design and development controls

The organization shall apply controls to the design and development process to ensure that:

• a) the results to be achieved are defined;
• b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements;
• c) verification activities are conducted to ensure that the design and development outputs meet the input requirements;
• d) validation  activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use;
• e) any necessary actions are taken on problems determined during the reviews, or verification and validation  activities;
• f) documented information of these activities is retained.

NOTE Design and development reviews, verification and validation  have distinct purposes. They can be conducted separately or in any combination, as is suitable for the products and services of the organization.

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8.3 Design and development of products and services (8.3.3)

8. OPERATION

8.3 Design and development of products and services

8.3.3 Design and development inputs

The organization shall determine the requirements essential for the specific types of products and services to be designed and developed.

The organization shall consider:

• a) functional and performance requirements;
• b) information derived from previous similar design and development activities;
• c) statutory and regulatory requirements;
• d) standards or codes of practice that the organization has committed to implement;
• e) potential consequences of failure due to the nature of the products and services.

Inputs shall be adequate for design and development purposes, complete and unambiguous.

Conflicting design and development inputs shall be resolved.

The organization shall retain documented information on design and development inputs.

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8.3 Design and development of products and services (8.3.2)

8. OPERATION

8.3 Design and development of products and services

8.3.2 Design and development planning

In determining the stages and controls for design and development , the organization shall consider:

• a) the nature, duration and complexity of the design and development activities;
• b) the required process stages, including applicable design and development reviews;
• c) the required design and development verification and validation activities;
• d) the responsibilities and authorities involved in the design and development process;
• e) the internal and external resource needs for the design and development of products and services
• f) the need to control interfaces between persons involved in the design and development process;
• g) the need for involvement of customers and users in the design and development process;
• h) the requirements for subsequent provision of products and services;
• i) the level of control expected for the design and development process by customers and other relevant interested parties;
• j) the documented information needed to demonstrate that design and development requirements have been met.

Cross reference
Clause 9.1.3 (Performance analysis and evaluation)

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8.2 Requirement for products and services (8.2.4)

8. OPERATION

8.2 Requirement for products and services

8.2.4 Changes to requirements for products and services

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

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8.2 Requirement for products and services (8.2.3)

8. OPERATION

8.2 Requirement for products and services

8.2.3 Review of requirements related to products and services

8.2.3.1

The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to a customer, to include:

• 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 the specified or intended use, when known;
• c) requirements specified by the organization;
• d) statutory and regulatory requirements applicable to the products and services;
• e) contract or order requirements differing from those previously expressed.

The organization shall ensure that contract or order requirements differing from those previously defined are resolved.

The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their 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.

8.2.3.2 Retain documented information

The organization shall retain documented information, as applicable:

• a) on the results of the review;
• b) on any new requirements for the products and services

Reference for requirement
Clause 8.5.1 (Production Control)

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8.1 Operational planning and control

8. OPERATION

8.1 Operational planning and control

The organization shall plan, implement and control the processes (see 4.4 via 4.4.1 & 4.4.2) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6 (via 6.1.1, 6.1.2, 6.2.1, 6.2.2 & 6.3), by:

• a) determining the requirements for the products and services;
• b) establishing criteria for:
• 1. the processes;
• 2. the acceptance of products and services;
• c) determining the resources needed to achieve conformity to the product and service requirements;
• d) implementing control of the processes in accordance with the criteria;
• e) determining and keeping documented information to the extent necessary:
• 1. to have confidence that the processes have been carried out as planned;
• 2. to demonstrate the conformity of products and services to their requirements.

NOTE “Keeping” implies both the maintaining and the retaining of documented information.

The output of this planning shall be suitable for the organization’s operations.

The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

The organization shall ensure that outsourced processes are controlled (see 8.4).



Reference for requirement
Clause 4.4.1 (QMS and its processes)
Clause 5.1.2 (Customer focus)
Clause 8.5.1 (Production Control)
Clause 8.5.5 (Post delivery activities)
Clause 9.1.3 (Performance analysis and evaluation)

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7.5 Documented information (7.5.3)

7. SUPPORT

7.5 Documented information

7.5.3 Control of documented information

7.5.3.1

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

• a) it is available and suitable for use, where and when it is needed;
• b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

7.5.3.2

For the control of documented information, the organization shall address the following activities, as applicable:

• a) distribution, access, retrieval and use;
• b) storage and preservation, including preservation of legibility;
• c) control of changes (e.g. version control);
• d) retention and disposition.

Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled.

Documented information retained as evidence of conformity shall be protected from unintended alterations.

NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented

Cross reference
Clause 10.2.1 (Nonconformity and corrective action)

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