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Cross-Framework Mapping

ISO 9001vsISO 13485:2016

See exactly how ISO 9001 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.

17
Controls Mapped
31
Gaps Found
17%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 9001 maps to ISO 13485:2016 with 17% coverage across 8 directly mapped controls. Analysis of 48 ISO 9001 controls identifies 40 compliance gaps — primarily concentrated in ISO 9001: Leadership & Planning.

Source: TheArtOfService Knowledge Graph | 48 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 17 of 17 mapped controls across 7 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Policy(1 mappings)

9001-5.2Quality Policy
→iso-13485-2016::5.3Quality policy

Objectives(1 mappings)

9001-6.2Quality Objectives and Planning
→iso-13485-2016::5.4.1Quality objectives

Design(9 mappings)

9001-8.3Design and Development9 targets
→iso-13485-2016::7.3Design and development
→iso-13485-2016::7.3.10Design and development files
→iso-13485-2016::7.3.2Design and development planning
→iso-13485-2016::7.3.3Design and development inputs
→iso-13485-2016::7.3.4Design and development outputs
→iso-13485-2016::7.3.5Design and development review
→iso-13485-2016::7.3.6Design and development verification
→iso-13485-2016::7.3.7Design and development validation
→iso-13485-2016::7.3.8Design and development transfer

Operations(2 mappings)

9001-8.5Production and Service Provision2 targets
→iso-13485-2016::7.5Production and service provision
→iso-13485-2016::7.5.1Control of production and service provision

Audit(1 mappings)

9001-9.2Internal Audit
→iso-13485-2016::8.2.4Internal audit

Review(1 mappings)

9001-9.3Management Review
→iso-13485-2016::5.6Management review

ISO 9001: Operational Controls(2 mappings)

ISO9001-08Design and development controls
→iso-13485-2016::7.3Design and development
ISO9001-10Production and service provision controls
→iso-13485-2016::7.5Production and service provision

Related Comparisons

Other ISO 9001 comparisons

ISO 9001 vs ISO 9001:201527 mappingsISO 9001 vs ISO 22000:201818 mappingsISO 9001 vs ISO/IEC 42001:202315 mappingsISO 9001 vs ISO 27701:201915 mappingsISO 9001 vs ISO 14001:201515 mappingsISO 9001 vs ISO 22301:201914 mappingsISO 9001 vs ISO 37301:202114 mappingsISO 9001 vs ISO 37001:201614 mappings

Other ISO 13485:2016 comparisons

ISO 10005:2005 vs ISO 13485:201625 mappingsISO 19011:2018 vs ISO 13485:201620 mappingsISO 9001:2015 vs ISO 13485:201616 mappingsISO 50001:2018 - Energy Management Systems vs ISO 13485:201614 mappingsISO 39001:2012 - Road Traffic Safety Management vs ISO 13485:201613 mappingsISO/IEC 38500:2024 vs ISO 13485:201613 mappingsISO 41001:2018 - Facility Management Systems vs ISO 13485:201612 mappingsISO 22313:2020 - Guidance on Business Continuity Management Systems vs ISO 13485:201612 mappings

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What are the key differences between ISO 9001 and ISO 13485:2016?

ISO 9001 has 48 controls across its framework, while ISO 13485:2016 covers 83 controls. Direct mapping analysis identifies 8 overlapping controls (17% coverage). The frameworks diverge most significantly in ISO 9001: Leadership & Planning, where 9 ISO 9001 controls have no direct ISO 13485:2016 equivalent.

How many controls map between ISO 9001 and ISO 13485:2016?

Of 48 total ISO 9001 controls, 8 map directly to ISO 13485:2016 controls — representing 17% coverage. The remaining 40 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 9001 to ISO 13485:2016?

40 ISO 9001 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in ISO 9001: Leadership & Planning with 9 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 9001 and ISO 13485:2016?

The domain with the highest gap count is ISO 9001: Leadership & Planning (9 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.