Management system guidance
8.0 Operation
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8.6 Release of products and services
This requirement is unchanged in ISO 9001:2026. It continues ISO 9001:2015 clause 8.6, which derived from ISO 9001:2008 Clause 8.2.4 Monitoring and Measurement of Product. Your organization must show evidence that planned arrangements (methods, techniques, formats, etc.) are in place to verify that product and service requirements have been met.
These checks should take place at appropriate stages of production and service provision. Documented information must be available as evidence of the release, showing conformity with the acceptance criteria and traceability to the person(s) who authorized the release; the auditor will verify this. If you need a procedure and forms to help control your business's testing and inspection process, click here.
The release of product or delivery of service must not be completed until the planned arrangements (see 8.1) have been completed satisfactorily. The release of product may include, according to product planning and the verification stages; release to the next operation, release to an internal customer, or release to final customer, etc.
Planned arrangements can include design verification and design validation, which can involve modelling, simulations, experiments, trials, prototypes, functional testing, performance testing; inspections comprising, in-process, first article and final inspection; thorough examination through destructive and non-destructive testing; customer acceptance testing, product certification/qualification, third party qualification from a regulator, recognized society, or independent testing body etc.
For product release or service delivery, the planned arrangements may be bypassed only where this is approved by a relevant authority and, as applicable, by the customer. Monitor and measure product characteristics to ensure they are able to demonstrate:
- Product characteristics are continually met;
- Evidence of conformity with product requirements.
Documented information providing 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.).
More information on PDCA
Planning
Context
Planning
Support
Doing
Support
Operations
Checking
Monitoring, measurement, analysis and evaluation
Acting
Improvement
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