FDA Quality Management System Regulation (QMSR)
What is FDA Quality Management System Regulation (QMSR)?
The new 21 CFR Part 820 (Quality Management System Regulation, QMSR) was published as a Final Rule on 31 January 2024 (89 FR 7496) and applies from 2 FEBRUARY 2026. It HARMONISES the FDA medical device quality system requirements with ISO 13485:2016 by INCORPORATING THAT STANDARD BY REFERENCE under §820.7 + retaining a small number of FDA-specific additions (§820.15 clarifications + §820.35 record controls including audit trail + UDI + reporting + §820.45 device labelling + packaging controls). It comprises 13 controls organised across 7 domains, and applies in the United States.
How FDA Quality Management System Regulation (QMSR) maps to other frameworks
All 13 controls, each one mapped to the equivalent requirement in other standards, with the evidence that carries across and the mappings that were judged and rejected shown alongside. No account needed to look.
See the control mappings →The 7 domains FDA Quality Management System Regulation (QMSR) groups its controls into
Frameworks that share controls with FDA Quality Management System Regulation (QMSR)
Each of these has at least one control mapped to a control in FDA Quality Management System Regulation (QMSR). The number is how many FDA Quality Management System Regulation (QMSR) controls are shared, counted from the mapping graph.
SWIFT CSCF
5 shared controlsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
5 shared controlsBRCGS Global Standard for Food Safety Issue 9
5 shared controlsIEC 60601-1 - Medical Electrical Equipment Safety
4 shared controlsSQF Code Edition 9 - Safe Quality Food
4 shared controlsAS9100D - Aerospace Quality Management System
4 shared controlsGAMP 5 - Good Automated Manufacturing Practice
4 shared controlsSouth Korea ISMS-P
4 shared controlsTraining on frameworks that overlap FDA Quality Management System Regulation (QMSR)
There is no course on FDA Quality Management System Regulation (QMSR) itself. These cover frameworks that share controls with it, so the material carries across even though the standard named is different.
Where FDA Quality Management System Regulation (QMSR) overlaps with the standards you already hold
What an auditor will ask you for
All 13 FDA Quality Management System Regulation (QMSR) controls, each with what it requires, the artefacts an auditor will ask you for, and where it commonly fails. Free to read, nothing to fill in.
Read the FDA Quality Management System Regulation (QMSR) evidence request listWhat FDA Quality Management System Regulation (QMSR) means in your sector
What FDA Quality Management System Regulation (QMSR) means for your job
Questions people ask about FDA Quality Management System Regulation (QMSR)
What is FDA Quality Management System Regulation?
How many controls does FDA Quality Management System Regulation have?
Where does FDA Quality Management System Regulation apply?
What frameworks does FDA Quality Management System Regulation map to?
How do I get started with FDA Quality Management System Regulation compliance?
Query FDA Quality Management System Regulation (QMSR) programmatically
FDA Quality Management System Regulation (QMSR), its 13 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
FDA Quality Management System Regulation (QMSR) API reference and MCP config →What FDA Quality Management System Regulation (QMSR) requires, control by control
Each page carries the requirement text for one FDA Quality Management System Regulation (QMSR) control and what an assessor expects to see as evidence.
- QMSR-820-10 Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)
- QMSR-820-15 Clarification of concepts (§820.15)
- QMSR-820-35 Control of records - record retention, audit trail, UDI, medical-device reporting (§820.35)
- QMSR-820-45 Device labelling and packaging controls (§820.45)
- 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-SEC8 Measurement, analysis and improvement (ISO 13485:2016 Section 8)
How ready are you for FDA Quality Management System Regulation (QMSR)?
Answer 25 questions and get a professional readiness report with gap analysis, maturity scores, and prioritised action items. Results in 5 minutes.