FDA Quality Management System Regulation (QMSR)vsISO 13485:2016
See exactly how FDA Quality Management System Regulation (QMSR) controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA Quality Management System Regulation (QMSR) maps to ISO 13485:2016 with 23% coverage across 1 directly mapped controls. Analysis of 13 FDA Quality Management System Regulation (QMSR) controls identifies 12 compliance gaps — primarily concentrated in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8).
Source: TheArtOfService Knowledge Graph | 13 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 1 of 1 mapped controls across 1 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
QMSR: Clarification of Concepts and Definitions (§820.15)(1 mappings)
Related Comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
Other ISO 13485:2016 comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 718 frameworks — at a fraction of consulting costs.
Free
- ✓ 718 framework browser
- ✓ Cross-framework mappings (332K+)
- ✓ 824 compliance assessments
- ✓ 3 AI queries & searches per day
Professional
- ✓ Unlimited AI Compliance Advisory
- ✓ Unlimited full-text search
- ✓ Framework self-assessment
- ✓ PDF, Excel & CSV exports
What are the key differences between FDA Quality Management System Regulation (QMSR) and ISO 13485:2016?
FDA Quality Management System Regulation (QMSR) has 13 controls across its framework, while ISO 13485:2016 covers 60 controls. Direct mapping analysis identifies 1 overlapping controls (23% coverage). The frameworks diverge most significantly in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8), where 6 FDA Quality Management System Regulation (QMSR) controls have no direct ISO 13485:2016 equivalent.
How many controls map between FDA Quality Management System Regulation (QMSR) and ISO 13485:2016?
Of 13 total FDA Quality Management System Regulation (QMSR) controls, 1 map directly to ISO 13485:2016 controls — representing 23% coverage. The remaining 12 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping FDA Quality Management System Regulation (QMSR) to ISO 13485:2016?
12 FDA Quality Management System Regulation (QMSR) controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8) with 6 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.
Which control domains have the most gaps between FDA Quality Management System Regulation (QMSR) and ISO 13485:2016?
The domain with the highest gap count is QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8) (6 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.