Does ISO/SAE 21434 cover FDA Quality Management System Regulation (QMSR)?

46% of FDA Quality Management System Regulation (QMSR) you already have

ISO/SAE 21434 already covers about 46% of FDA Quality Management System Regulation (QMSR), leaving 7 of 13 controls as genuinely new work.

Already covered 1 Likely covered 5 New work 7

What is genuinely new work

Nothing in ISO/SAE 21434 reaches these. This is the list to scope.

QMSR-820.15

Clarification of concepts (§820.15)

QMSR-820.1_3_7

Scope, definitions and incorporation by reference (§§820.1, 820.3, 820.7)

QMSR-820.35

Control of records - record retention, audit trail, UDI, medical-device reporting (§820.35)

QMSR-Coord-ISO13485-MDR-IVDR-Part11

Coordination with ISO 13485:2016, EU MDR/IVDR, FDA Part 11, Cybersecurity Guidance

QMSR-ISO13485-Sec6

Resource management (ISO 13485:2016 Section 6 - incorporated via §820.10)

QMSR-Status

FDA QMSR - corpus status, enforcement landscape, future evolution

QMSR-Transition

Transition from prior QSR + 2 February 2026 application + FDA inspection approach

Show the 6 you already have

QMSR-820.45

Device labelling and packaging controls (§820.45)

QMSR-820.10

Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)

QMSR-ISO13485-Sec5

Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)

QMSR-ISO13485-Sec7_DesignControls

Product realization - Design and Development controls (ISO 13485:2016 Section 7.3)

QMSR-ISO13485-Sec7_Purchasing

Purchasing controls + supplier management (ISO 13485:2016 Section 7.4)

QMSR-ISO13485-Sec8

Measurement, analysis and improvement (ISO 13485:2016 Section 8)

How this is calculated

Already covered means a mapping runs from a control in ISO/SAE 21434 to that control. Likely covered means no direct mapping exists but both frameworks map to the same control in a third standard. New work means neither. We keep those separate rather than adding them into one friendlier number, because blending them would present a two-hop inference as a verified fact.

Coverage is not symmetric. Run it the other way and you will get a different number; both are correct.

From 332,959 cross-framework control mappings across 723 frameworks, 531 of them verified against their source documents. It does not tell you that you are compliant: a mapped control means the two standards ask for the same thing, not that you have done it.

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