Iso 13485 Preservation Of Product
Iso 13485 Preservation Of Product
.Clause 7.5 of, which deals with requirements for production and service provision, causes a lot of confusion. The main reason for this is the fact that the standard aims to define requirements applicable to a wide variety of manufacturing and service provision processes in the medical device industry. The requirements had to be general enough to apply to different processes, yet specific enough to be relevant and auditable. Clause 7.5 has 11 sections and below are explanations and clarifications on applying these to your company. Control of production and service provisionSub clause 7.5.1 contains general requirements for the production and service provision process. It requires the organization to plan, carry out, monitor and control the production and service provision process in order to ensure a product that conforms to specification.