Framework overlap

Does API 1164 cover FDA Quality Management System Regulation (QMSR)?

You hold API 1164 and have been told to do FDA Quality Management System Regulation (QMSR). Here is how much overlaps, control by control.

62% of FDA Quality Management System Regulation (QMSR) you already have

API 1164 already covers about 62% of FDA Quality Management System Regulation (QMSR), leaving 5 of 13 controls as genuinely new work.

Already covered 2 Likely covered 6 New work 5

What is genuinely new work

Nothing in API 1164 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-Status
FDA QMSR - corpus status, enforcement landscape, future evolution
QMSR-Transition
Transition from prior QSR + 2 February 2026 application + FDA inspection approach
Show the 8 you already have
QMSR-820.45
Device labelling and packaging controls (§820.45)
QMSR-ISO13485-Sec7_Purchasing
Purchasing controls + supplier management (ISO 13485:2016 Section 7.4)
QMSR-820.10
Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)
QMSR-Coord-ISO13485-MDR-IVDR-Part11
Coordination with ISO 13485:2016, EU MDR/IVDR, FDA Part 11, Cybersecurity Guidance
QMSR-ISO13485-Sec5
Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)
QMSR-ISO13485-Sec6
Resource management (ISO 13485:2016 Section 6 - incorporated via §820.10)
QMSR-ISO13485-Sec7_DesignControls
Product realization - Design and Development controls (ISO 13485:2016 Section 7.3)
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 API 1164 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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