7.5.6 Validation of processes for production and service provision

The organization shall validate any processes for production and service provision where the resulting output cannot be or is not 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 consistently.

The organization shall document procedures for validation of processes, including:

a) defined criteria for review and approval of the processes;

b) equipment qualification and qualification of personnel;

c) use of specific methods, procedures and acceptance criteria;

d) as appropriate, statistical techniques with rationale for sample sizes;

e) requirements for records (see 4.2.5);

f) revalidation, including criteria for revalidation;

g) approval of changes to the processes.

The organization shall document procedures for the validation of the application of computer software used in production and service provision. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application. The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software, including the effect on the ability of the product to conform to specifications.

Records of the results and conclusion of validation and necessary actions from the validation shall be

maintained (see 4.2.4 and 4.2.5).