ISO 9001:2015 requires organisations to implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met.

The release of products and services to the customer must also not proceed until all planned arrangements have been satisfactorily completed, unless an early release has been approved by a relevant authority and, if applicable, also by the customer.

Organisation are also required to retain documented information (records) on the release of products and services.

These records must include:

1. Evidence of acceptance criteria conformity,
2. Traceability to the person or persons authorising the release of the products or services.

Comment:

Note that this clause refers to “products and services” rather than just “products” which underpins the applicability to organisations whose primary product is service provision.

In many businesses, and certainly most whose activities are based around manufacturing, it is typical for verification activities (some form of checking) to be planned and executed at a process step, prior to it progressing to the next, to ensure each operation is carried out correctly. This may be through manual checks by suitably trained and competent personnel, using calibrated equipment (see also articles 7.1.5 Monitoring and measuring resources, 7.1.6 Organisational knowledge and 7.2 Competence,) or by other means, including automated verification such as Poke-Yoke (error proofing) devices. Evidence of meeting specified requirements can take the form of physical stamps, signatures, the application of labels or electronic methods such as scanning for instance.

Typical means of identifying these verification points and activities are through appropriate quality planning activities which should take the risk based approach and may be documenting in the form of Quality / Control Plans and as required, appropriate instructions at the point of use which may include sampling frequency / sample size as well as acceptance criteria. (See articles 7.5.1, 7.5.2 and 7.5.3 Documented information and 8.5.1 Control of production and service provision.)

Final checks before shipping is a common customer / industry requirement which can again take many forms such as dimensional verification or performance validation functional testing. There must be a record of conformity and traceability to release authorisation.

Audit Check:

Typically, auditors will wish to confirm through the course of an audit that requirements are clearly specified, (control plans / work instructions / drawings / specifications,) and that records are available to confirm products or services released comply with specifications, including traceability to the persons authorising release at the relevant process stages (labels, sign off’s, electronic stamps or other means.)

If any evidence of early release is found during the course of an audit. IE before all final checks have been completed, evidence of appropriate authorisation will also be sought, typically through examination of concession records. (See article 8.7 Control of nonconforming outputs.)