8.

6 Release of Products and 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 defined in 8.1 have been met. 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 inviove
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 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.).