Section 820.10 establishes the substantive QMS requirements by incorporating ISO 13485:2016 SECTIONS 4 THROUGH 8 in full. Manufacturers must implement: ISO 13485:2016 SECTION 4 General QMS requirements + documentation (Quality Manual + Medical Device File + control of documents + records); SECTION 5 Management responsibility + customer focus + quality policy + planning + responsibility / authority / communication + management review; SECTION 6 Resource management (provision of resources + human resources + infrastructure + work environment + contamination control); SECTION 7 Product realization (planning + customer-related + design and development - the medical-device 'design controls' parallel + purchasing + production and service provision + control of monitoring + measuring equipment); SECTION 8 Measurement + analysis + improvement (monitoring + measurement + control of nonconforming product + analysis of data + improvement - including CAPA Sections 8.5.2 + 8.5.3). The QMSR adopts ISO 13485:2016 VERBATIM with limited FDA-specific additions (§§820.15 + 820.35 + 820.45). NB: §820.10 also clarifies that ISO 13485:2016 internal-audit + management-review requirements (Sections 8.2.4 + 5.6) apply to the QMSR.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.