ISO 13485:2016 Section 5 (Management Responsibility) incorporated via §820.10. ELEMENTS: (5.1) MANAGEMENT COMMITMENT to develop + implement + maintain the QMS + improve its effectiveness; (5.2) CUSTOMER FOCUS - identify + meet customer + regulatory requirements; (5.3) QUALITY POLICY appropriate to the purpose of the organization + commitment to comply + continually improve; (5.4) PLANNING - quality objectives at relevant functions + levels + planning of changes affecting the QMS; (5.5) RESPONSIBILITY + AUTHORITY - clear definition + communication; designation of management representative who has the authority + responsibility for the QMS; internal communication processes appropriate to the effectiveness of the QMS; (5.6) MANAGEMENT REVIEW - at planned intervals to ensure continuing suitability + adequacy + effectiveness of the QMS; review of feedback + complaints + monitoring + measurement + audit results + status of CAPA + follow-up actions from previous review + changes that could affect the QMS + recommendations for improvement; outputs including improvement decisions + resource needs + product / process improvements.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.