The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned results.
The organization shall establish arrangements for these processes including, as applicable,
- defined criteria for review and approval of the processes
- approval of equipment and qualification of personnel
- use of specific methods and procedures
- requirements for records (see 4.2.4)