13485 P-7511 Preservation of Product

ISO 13485:2016 Procedure - Preservation of Product - describe the process for handling, packaging, storage and protection of materials, parts and products. This includes handling requirements such as ESD protection, Clean Rooms, and Temperature Controls. You may want to have the detail in the work instructions you write for process control and state: requirements are documented in the work instructions. We take a similar approach for Packaging and Storage. Handling, Packaging and Storage are all covered in the Preservation of Product procedure.