Product and service provision
The ISO Navigator™ database hyperlinks the ISO 9000 principles and the ISO 9001 requirements; and explains them in plain English with practical guidance.
ISO 9001: Process validation 7.5.2
Sometimes it is not possible to fully verify the quality of the final product without using it or by performing a destructive test. In this case, activities must be controlled through the use of qualified personnel, qualified equipment and qualified processes based on specific procedures.
A process output can be validated, for example, by doing a destructive test on a sample of the products. The results of this destructive test will then be representative the intrinsic quality of other products with the same characteristics. Validate production and services by:
- Proving that special processes have achieved planned outputs
- Proving that process owners are capable of achieving planned results
- Proving that process equipment is capable of achieving planned results
- Maintaining records