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Cross-Framework Mapping

ISO 13485:2016vsISO 9001:2015

See exactly how ISO 13485:2016 controls map to ISO 9001:2015. Pre-computed mappings, identified gaps, and coverage analysis.

34
Controls Mapped
49
Gaps Found
19%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485:2016 maps to ISO 9001:2015 with 19% coverage across 16 directly mapped controls. Analysis of 83 ISO 13485:2016 controls identifies 67 compliance gaps — primarily concentrated in Product realization – ISO 13485:2016.

Source: TheArtOfService Knowledge Graph | 83 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 34 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Clause 0 – ISO 13485:2016(1 mappings)

iso-13485-2016::0.3Process approach
→iso-9001-2015::0.3Process approach

Quality management system – ISO 13485:2016(10 mappings)

iso-13485-2016::4.1General requirements10 targets
→iso-9001-2015::0.1General
→iso-9001-2015::0.3.1General
→iso-9001-2015::10.1General
→iso-9001-2015::5.1.1General
→iso-9001-2015::7.1.1General
→iso-9001-2015::7.5.1General
→iso-9001-2015::8.3.1General
→iso-9001-2015::8.4.1General
→iso-9001-2015::9.1.1General
→iso-9001-2015::9.3.1General

Management responsibility – ISO 13485:2016(6 mappings)

iso-13485-2016::5.2Customer focus
→iso-9001-2015::5.1.2Customer focus
iso-13485-2016::5.4Planning
→iso-9001-2015::6.3Planning of changes
iso-13485-2016::5.4.1Quality objectives
→iso-9001-2015::6.2Quality objectives and planning to achieve them
iso-13485-2016::5.6Management review3 targets
→iso-9001-2015::9.3Management review
→iso-9001-2015::9.3.2Management review inputs
→iso-9001-2015::9.3.3Management review outputs

Product realization – ISO 13485:2016(3 mappings)

iso-13485-2016::7.3Design and development3 targets
→iso-9001-2015::8.3Design and development of products and services
→iso-9001-2015::8.3.2Design and development planning
→iso-9001-2015::8.3.3Design and development inputs

+14 more mappings

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Related Comparisons

Other ISO 13485:2016 comparisons

ISO 13485:2016 vs ISO 10005:200525 mappingsISO 13485:2016 vs ISO 19011:201820 mappingsISO 13485:2016 vs ISO 900115 mappingsISO 13485:2016 vs ISO 50001:2018 - Energy Management Systems14 mappingsISO 13485:2016 vs ISO 39001:2012 - Road Traffic Safety Management13 mappingsISO 13485:2016 vs ISO/IEC 38500:202413 mappingsISO 13485:2016 vs ISO 41001:2018 - Facility Management Systems12 mappingsISO 13485:2016 vs ISO 22313:2020 - Guidance on Business Continuity Management Systems12 mappings

Other ISO 9001:2015 comparisons

ISO 22000:2018 vs ISO 9001:201556 mappingsISO 27701:2019 vs ISO 9001:201548 mappingsISO 22301:2019 vs ISO 9001:201542 mappingsISO 37301:2021 vs ISO 9001:201536 mappingsISO 50001:2018 - Energy Management Systems vs ISO 9001:201535 mappingsISO 37001:2016 vs ISO 9001:201534 mappingsISO 45001:2018 vs ISO 9001:201533 mappingsISO/IEC 42001:2023 vs ISO 9001:201532 mappings

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What are the key differences between ISO 13485:2016 and ISO 9001:2015?

ISO 13485:2016 has 83 controls across its framework, while ISO 9001:2015 covers 71 controls. Direct mapping analysis identifies 16 overlapping controls (19% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 24 ISO 13485:2016 controls have no direct ISO 9001:2015 equivalent.

How many controls map between ISO 13485:2016 and ISO 9001:2015?

Of 83 total ISO 13485:2016 controls, 16 map directly to ISO 9001:2015 controls — representing 19% coverage. The remaining 67 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 13485:2016 to ISO 9001:2015?

67 ISO 13485:2016 controls have no direct equivalent in ISO 9001:2015. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 24 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 13485:2016 and ISO 9001:2015?

The domain with the highest gap count is Product realization – ISO 13485:2016 (24 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.