8.5.1.2 Validation and Control of Special Processes

For processes where the resulting output cannot be verified by subsequent monitoring or measurement, the organization shall establish arrangements for these processes including, as applicable:

a. definition of criteria for the review and approval of the processes;

b. determination of conditions to maintain the approval;

c. approval of facilities and equipment;

d. qualification of persons;

e. use of specific methods and procedures for implementation and monitoring the processes;

f. requirements for documented information to be retained.