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Chapter 2
Merging the QSR and ISO 13485 into the QMSR
Chapter 2 explains exactly how and why FDA aligned the QSR with ISO 13485:2016 to create the QMSR. It begins by comparing the scope of QSR vs. QMSR, noting that the new 21 CFR 820 applies more broadly across the device lifecycle to include distribution, technical support, and certain outsourced services.
It then describes how the QMSR is structured around the Plan–Do–Check–Act cycle, mapping each ISO clause to its role. The QMSR incorporates ISO 13485 clauses 1–8 directly but supplements them with FDA-specific regulatory authority and expectations.
A major portion of the chapter explains the mapping from the QSR to the QMSR to show how QSR subparts correspond to each ISO clause and where FDA retained specific U.S. requirements.
It then outlines the three FDA additions that remain embedded in the new 21 CFR 820:
§820.10 – Requirements for a quality management system
§820.35 – Control of records
§820.45 – Device labeling and packaging controls
A table shows how the current Part 21 regulations integrate with ISO clauses.
The chapter concludes by stressing that compliance requires merging the ISO framework with mandatory FDA controls, not simply switching labels. Documentation, processes, and terminology must all be harmonized.
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