FDA Quality Management System Regulation (QMSR): every control, and what you already have

13 controls 155 frameworks share controls with it United States verified against its source document

Every control below is one this framework asks for. The right hand column counts how many other frameworks in our corpus carry the same control, which is the difference between doing this work once and doing it again for the next standard.

There is no implementation kit for this framework yet. The control list and the overlap above are free and complete.

What you already have

Frameworks whose controls overlap this one, most first. If you run any of them, the count is roughly what you have already evidenced.

If you run	Shared controls
ICH E6(R3)	6	measure it →
IEC 62304:2015 Medical Device Software Lifecycle Processes	5	measure it →
SWIFT CSCF	5	measure it →
GAMP 5	4	measure it →
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6	4	measure it →
IATF 16949:2016	4	measure it →
IEC 60601-1	4	measure it →
South Korea ISMS-P	4	measure it →
SQF Code Edition 9	4	measure it →
21 CFR Part 211	4	measure it →
AS9100D	3	measure it →
DAMA-DMBOK2	3	measure it →

Every control

Code	Control	Also in
`QMSR-820.10`	Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)	32
`QMSR-820.15`	Clarification of concepts (§820.15)	1
`QMSR-820.1_3_7`	Scope, definitions and incorporation by reference (§§820.1, 820.3, 820.7)	0
`QMSR-820.35`	Control of records - record retention, audit trail, UDI, medical-device reporting (§820.35)	1
`QMSR-820.45`	Device labelling and packaging controls (§820.45)	50
`QMSR-Coord-ISO13485-MDR-IVDR-Part11`	Coordination with ISO 13485:2016, EU MDR/IVDR, FDA Part 11, Cybersecurity Guidance	3
`QMSR-ISO13485-Sec5`	Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)	79
`QMSR-ISO13485-Sec6`	Resource management (ISO 13485:2016 Section 6 - incorporated via §820.10)	13
`QMSR-ISO13485-Sec7_DesignControls`	Product realization - Design and Development controls (ISO 13485:2016 Section 7.3)	10
`QMSR-ISO13485-Sec7_Purchasing`	Purchasing controls + supplier management (ISO 13485:2016 Section 7.4)	41
`QMSR-ISO13485-Sec8`	Measurement, analysis and improvement (ISO 13485:2016 Section 8)	19
`QMSR-Status`	FDA QMSR - corpus status, enforcement landscape, future evolution	0
`QMSR-Transition`	Transition from prior QSR + 2 February 2026 application + FDA inspection approach	0

Tell me when FDA Quality Management System Regulation (QMSR) files something new

One email when a public company newly discloses something this framework governs, naming the company and what our corpus says it puts in scope. Nothing else, and one click to stop.

What this page is

A control-level reference for FDA Quality Management System Regulation (QMSR), drawn from our framework corpus. Control codes and titles are references to the standard, not reproductions of it. The overlap counts and the auditor artefacts are our own work and are the part you will not find elsewhere.

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