The updated standard gives more details about what companies shall consider in the process of evaluation, selection and monitoring of their suppliers. Requirements are mostly written towards the medical devices legal manufacturer to control its suppliers, however it is critical that suppliers are also aware about them as they could also be ISO 13485 certified. With a clear reinforcement of the risk-based approach in the entire ISO 13485:2016, it is no exception that the Purchasing section (7.4) includes new provisions to strengthen Supplier control.
The publication of ISO 13485:2016 in March last year reinforced the notion of control of supply chain for Medical Device manufacturers.
