The certification body defines, for each function, over and above Annex A of ISO/IEC 17021-1, the knowledge and skills of Annex B Table B.2: generic quality management practice, the legal framework and the body's role, medical device risk management such as ISO 14971, the body's own ISO 13485 processes and medical device business and technology for all functions, and for auditors (with a technical expert where marked) knowledge of intended use, device risks and relevant product standards. For suppliers of parts and services it answers the Table B.1 questions: if the product is a nearly finished device, a component or part of a device, a regulated contracted activity such as relabelling or remanufacturing, supplied sterile, contains software from the client or a supplier, has design and development in scope, or is intended to support associated devices, the team includes the Tables A.1.1 to A.1.6 technical area competence and the full auditor requirements; if every answer is no, the parts and services auditor requirements suffice. The answers are documented.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.