13485 P-756 Validation Processes For Product

ISO 13485:2016 Procedure - Validation Processes For Product - describes the process for validation of processes for production and service provision where output cannot be verified by subsequent monitoring or measurement. Addresses the establishment of criteria for review and approval of the validation process, approval of equipment and qualification of personnel, approval and use of specific methods, procedures and instructions, requirements for records, and requirements for revalidation.