Evaluating Potential Medical Device Suppliers, Getting Them Started, and Implementing Effective Controls
Once you have established what you are purchasing and what type of supplier you need, it’s time to find qualified partners. The goal here is to plan and implement a consistent, risk-based approach for engaging new suppliers. It is important (and required in ISO 13485:2016) for you to have documented procedures, supplier evaluation and selection criteria, and a record of supplier evaluations you have performed along with subsequent actions. Section 7.4.1 of ISO 13485:2016 combines the words evaluation and selection, […]
» Read more