8.0 Operation

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8.6 Release of Products & Services

This requirement is comparable to ISO 9001:2008 Clause 8.2.4 Monitoring and Measurement of Processes. Your organization must show evidence that a process (method, techniques, formats, etc.) is in place to monitor and measure the characteristics of product to verify that requirements are being met. This must be accomplished at appropriate stages of the design and development process. The auditor will verify that records are maintained to provide evidence of conformity and indicate the person(s) authorizing the release of products.

The release of product or delivery of service must not be completed until the planned requirements (7.1) have been met. ‘Release’ of product may include, according to product planning and the verification stages, release to the next operation, release to an internal customer, release to final customer, etc.

Planned arrangements can include design verification/validation (modelling, simulations, experiments, trials, prototypes, functional testing, performance testing), inspection (stage, final, first article), examination (destructive/non-destructive), customer acceptance testing, product certification/qualification, third party qualification (regulator, society, independent body etc.),

For product release or service delivery, the planning requirements may be waived, but must be approved by relevant authority and by the customer as appropriate. Monitor and measure product characteristics to ensure they are able to demonstrate:

  1. Product characteristics are continually met;
  2. Evidence of conformity with product requirements.

Retain records to provide evidence that acceptance criteria have been met might include: e.g. certificate of conformity, release certificate, regulatory certificate.Ensure traceability to the person(s) authorizing the release such as name, authorized signatories, user identification, stamp impression etc., including their authority status (release signatory, certifying staff, scope of authorization etc.).

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