The audit team has the competence for the Annex A technical area of the audit scope together with the knowledge and skills of Annex B. For an organisation that only makes parts or offers services (Table A.1.7) the team need not show technical competence at the level required for a device manufacturer. Where the scope includes sterile devices or devices meant for end-user sterilisation, the team is competent in the relevant sterilisation process of Table 1.5.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.