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Cross-Framework Mapping

ISO 13485vsFDA Quality Management System Regulation (QMSR)

See exactly how ISO 13485 controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.

2
Controls Mapped
27
Gaps Found
3%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485 maps to FDA Quality Management System Regulation (QMSR) with 3% coverage across 1 directly mapped controls. Analysis of 29 ISO 13485 controls identifies 28 compliance gaps — primarily concentrated in ISO 13485: Administrative Safeguards.

Source: TheArtOfService Knowledge Graph | 29 controls analysed | 723 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 2 of 2 mapped controls across 1 domains. Sign up to explore all 332K+ mappings across 723 frameworks.

Improvement(2 mappings)

8.5Control effectiveness review2 targets
→QMSR-ISO13485-Sec6Resource management (ISO 13485:2016 Section 6 - incorporated via §820.10)
→QMSR-ISO13485-Sec7_PurchasingPurchasing controls + supplier management (ISO 13485:2016 Section 7.4)

Related Comparisons

Other ISO 13485 comparisons

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Other FDA Quality Management System Regulation (QMSR) comparisons

ICH E6(R3) - Good Clinical Practice vs FDA Quality Management System Regulation (QMSR)6 mappingsSWIFT CSCF vs FDA Quality Management System Regulation (QMSR)5 mappingsBRCGS Global Standard for Food Safety Issue 9 vs FDA Quality Management System Regulation (QMSR)5 mappingsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs FDA Quality Management System Regulation (QMSR)5 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs FDA Quality Management System Regulation (QMSR)5 mappings21 CFR Part 211 - Current Good Manufacturing Practice vs FDA Quality Management System Regulation (QMSR)4 mappingsIEC 60601-1 - Medical Electrical Equipment Safety vs FDA Quality Management System Regulation (QMSR)4 mappingsGLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6 vs FDA Quality Management System Regulation (QMSR)4 mappings

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What are the key differences between ISO 13485 and FDA Quality Management System Regulation (QMSR)?

ISO 13485 has 29 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 1 overlapping controls (3% coverage). The frameworks diverge most significantly in ISO 13485: Administrative Safeguards, where 6 ISO 13485 controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.

How many controls map between ISO 13485 and FDA Quality Management System Regulation (QMSR)?

Of 29 total ISO 13485 controls, 1 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 3% coverage. The remaining 28 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 13485 to FDA Quality Management System Regulation (QMSR)?

28 ISO 13485 controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in ISO 13485: Administrative Safeguards 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 ISO 13485 and FDA Quality Management System Regulation (QMSR)?

The domain with the highest gap count is ISO 13485: Administrative Safeguards (6 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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.