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Cross-Framework Mapping

ISO 13485:2016vsISO 45001:2018

See exactly how ISO 13485:2016 controls map to ISO 45001:2018. Pre-computed mappings, identified gaps, and coverage analysis.

5
Controls Mapped
55
Gaps Found
7%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485:2016 maps to ISO 45001:2018 with 7% coverage across 4 directly mapped controls. Analysis of 60 ISO 13485:2016 controls identifies 79 compliance gaps — primarily concentrated in Product realization – ISO 13485:2016.

Source: TheArtOfService Knowledge Graph | 60 controls analysed | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 5 of 5 mapped controls across 2 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

Management responsibility – ISO 13485:2016(3 mappings)

iso-13485-2016::5.4Planning
→iso-45001-2018::6.2.2Planning to achieve OH&S
iso-13485-2016::5.5.3Internal communication
→iso-45001-2018::7.4.2Internal communication
iso-13485-2016::5.6Management review
→iso-45001-2018::9.3Management review

Measurement, analysis and improvement – ISO 13485:2016(2 mappings)

iso-13485-2016::8.2.4Internal audit2 targets
→iso-45001-2018::9.2Internal audit
→iso-45001-2018::9.2.2Internal audit programme

Related Comparisons

Other ISO 13485:2016 comparisons

ISO 13485:2016 vs PIC/S Guide to Good Manufacturing Practice for Medicinal Products4 mappingsISO 13485:2016 vs ICH E6(R3) - Good Clinical Practice4 mappingsISO 13485:2016 vs FDA Quality Management System Regulation (QMSR)4 mappingsISO 13485:2016 vs ISO 20000-14 mappingsISO 13485:2016 vs ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence4 mappingsISO 13485:2016 vs ISO 140014 mappingsISO 13485:2016 vs ASIS SPC.1-2009 - Organizational Resilience Standard4 mappingsISO 13485:2016 vs AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence4 mappings

Other ISO 45001:2018 comparisons

BRCGS Global Standard for Food Safety Issue 9 vs ISO 45001:20186 mappingsPIC/S Guide to Good Manufacturing Practice for Medicinal Products vs ISO 45001:20186 mappingsICH E6(R3) - Good Clinical Practice vs ISO 45001:20186 mappingsFDA Quality Management System Regulation (QMSR) vs ISO 45001:20186 mappingsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs ISO 45001:20186 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs ISO 45001:20186 mappingsISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories vs ISO 45001:20186 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs ISO 45001:20186 mappings

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What are the key differences between ISO 13485:2016 and ISO 45001:2018?

ISO 13485:2016 has 60 controls across its framework, while ISO 45001:2018 covers 37 controls. Direct mapping analysis identifies 4 overlapping controls (7% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 33 ISO 13485:2016 controls have no direct ISO 45001:2018 equivalent.

How many controls map between ISO 13485:2016 and ISO 45001:2018?

Of 60 total ISO 13485:2016 controls, 4 map directly to ISO 45001:2018 controls — representing 7% coverage. The remaining 79 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 45001:2018?

79 ISO 13485:2016 controls have no direct equivalent in ISO 45001:2018. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 33 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 45001:2018?

The domain with the highest gap count is Product realization – ISO 13485:2016 (33 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.