ISO 13485:2016 Section 7.4 (Purchasing) - the supplier-management framework. (7.4.1) PURCHASING PROCESS - documented procedures for evaluation + selection + monitoring + re-evaluation of suppliers based on supplier's ability to supply product meeting requirements; criteria for evaluation including impact on quality of medical device + risk associated with medical device; periodic monitoring + re-evaluation per planned intervals; records of evaluation + selection + monitoring + re-evaluation + actions arising. (7.4.2) PURCHASING INFORMATION - description of product to be purchased including: (a) product specifications; (b) requirements for acceptance + qualification of personnel; (c) QMS requirements; (d) regulatory requirements; the manufacturer must ensure that requirements are adequate. (7.4.3) VERIFICATION OF PURCHASED PRODUCT - inspection + verification activities for purchased product; the extent of verification activities based on supplier evaluation results + risk associated with the product; records of verification.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.