Guidance

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:

  1. Proving that special processes have achieved planned outputs
  2. Proving that process owners are capable of achieving planned results
  3. Proving that process equipment is capable of achieving planned results
  4. Maintaining records