At initial assessment the accreditation body's sample of audits to witness includes at least one audit from a technical area of higher risk class inside every main technical area of Annex 1 that the applied-for scope covers, judged by a suitable risk classification scheme, national or international, or by the criticality of the process (sterilisation, or parts and services, for example). In building the witnessing schedule the body should also weigh the certification body's experience, such as recognition under a medical device regulatory scheme (the European MDR and IVDR, the ASEAN Medical Device Directive or national regulations using ISO 13485), to rationalise the schedule.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.