For each accreditation function the body defines the knowledge and skills Annex 2 requires: quality system principles for review and assessment roles; understanding of the GHTF SG3 and SG4 documents maintained by IMDRF, of ISO 13485 and of general regulatory requirements for device manufacturers; a general view of medical devices, what they are for and their safety and risks; the legal framework and the role of auditing organisations; the information needed to judge the competence required of audit and assessment teams and for certification and accreditation decisions; the ability to confirm the certification body's processes and competence support the ISO 13485 scheme; the ability to set assessment duration and deploy assessor competences; identification of devices with their complexities, technologies, intended use and risk classifications; knowledge of factors shaping a certification programme in a regulated environment; and understanding of accredited certification work, of the Global ACI mandatory documents for the scheme and of ISO/IEC 17021-1, at the level each function needs.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.