13485 P-750 Control of Production & Service

ISO 13485:2016 Procedure - Control of Production & Service - describe the process used to provide controlled conditions for product realization processes. Our procedure references the planning procedure and the design procedure as identifying the controls for the process and then goes on to state how product specifications, quality control measures, and approvals are identified. Also covered in this procedure is the need for validation of processes, and how product release criteria are documented and followed.