Top management must record the appointment of a management representative (by name or title, for example in the quality manual, organisation chart or position description) with defined responsibility and authority for ensuring QMS processes are established, implemented and maintained, telling top management how the QMS is performing and improvement needs, and promoting awareness of regulatory and QMS requirements across the organisation. Where the representative personally decides whether product meets requirements, their competence, including in the relevant regulations, must be shown. Clauses: ISO 13485:2016 5.5.2; TG(MD)R Sch 3 Pt 1 cl 1.4(5)(b)(ii); RDC 665/2022 Art 9; MO169 Art 16.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.