- The ISO 9001 standard talks about the need to implement planned arrangements.
- You have to ensure that the product meets specifications and is fit for its purpose.
- Make sure you are able to show who made certain decisions and that they are authorized to do so.
Release of the product or services is about verification that the product and service requirements have been met according to customer requirements.
Release activities aim to ensure that the realization of the product or the service has been expectedly completed and that the product or the service meets all its requirements and, is ready for delivery to the customer.
Practically, you need to make sure, to examine if the product is assembled or is it manufactured from conformed materials, or components and all the necessary operations were performed. And, in the end, that the required controls were applied, and the results were satisfactory.
To maintain effective release activities, you have to ensure that all required inputs and data are available to the relevant person at the time of the release. This information shall assist the person in deciding whether the product meets its requirements or not:
- Evidence that the product went through all the necessary process stages
- Characteristic evidence that the product meets its requirements: quality tests, verifications, and validations are available and clear
- All the required resources were available at the time of the realization
Acceptance Criteria or Standard Measures for Release
It’s important to make sure that the release is approved against defined acceptance criteria. The criteria for the release has to be available to adequate persons at the adequate process stage. With these, the use of the criteria will be clear to the person who carries out the release activities.
Authorizing the Release
The authorized person in your company should perform the release of the product or service. This person shall allow the release of the product for further use after a defined verification (the release activities) and with satisfactory results. Keep in mind, you have to keep the authorization of the release as documented information.
The person who allows the release provides traceability to qualifications and then accountability of the person by documenting the process. This traceability will assist the organization in case quality problems arise later.
Keeping Documented Information of the Release
Make sure to document the review, approval, and release and maintain it as documented information. The goals of the documented information are to identify the release activities and to prove that the product requirements are met.