ISO 9001:2000

7.5.2 Validation of Processes for Production and Service Provision

Change: Additional Requirements
Procedure Required: NO
Record(s) Required: NONE

Comments:
This section requires the organization to validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation must demonstrate the ability of these processes to achieve planned results. The organization must establish arrangements for these processes including, as applicable

a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records, and
e) re-validation.

Previous versions of ISO 9001 had referred to this topic as "Special Processes". Ultimately, this section is often not applicable in many industries. The most common examples of processes that could require validation involve welding or soldering.
It is curious that "service provision" was included in this section because many services can not be verified by subsequent monitoring or measurement. Strictly speaking, this means that all services that cannot be verified by subsequent monitoring or measurement require validation of their process!