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 (8.5.2)

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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7.1 Resources (7.1.5)

7. SUPPORT

7.1 Resources

7.1.5 Monitoring and measuring resources

7.1.5.1 General

The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.

The organization shall ensure that the resources provided:

• a) are suitable for the specific type of monitoring and measurement activities being undertaken;
• b) are maintained to ensure their continuing fitness for their purpose.

The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.

7.1.5.2 Measurement traceability

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:

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

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



Cross reference
Clause 4.4.1 (QMS and its processes)
Clause 8.5.1 (Production Control)

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