TheArtOfService
Cross-Framework Mapping

ISO 45001:2018vsISO 13485:2016

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

11
Controls Mapped
26
Gaps Found
14%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 45001:2018 maps to ISO 13485:2016 with 14% coverage across 5 directly mapped controls. Analysis of 37 ISO 45001:2018 controls identifies 32 compliance gaps — primarily concentrated in Planning.

Source: TheArtOfService Knowledge Graph | 37 controls analysed | 700 frameworks | 323K+ cross-framework mappings

Control Mappings

Showing 11 of 11 mapped controls across 4 domains. Sign up to explore all 323K+ mappings across 700 frameworks.

Context of the organization(6 mappings)

4.1Password Policy3 targets
→5.3Determining and Evaluating Audit Programme Risks
→7.1Cyber Incident Response Planning
→8.5.2Service Design and Transition
4.2Multi-Factor Authentication3 targets
→5.3Determining and Evaluating Audit Programme Risks
→7.1Cyber Incident Response Planning
→8.5.2Service Design and Transition

Leadership and worker participation(2 mappings)

5.3Determining and Evaluating Audit Programme Risks2 targets
→7.1Cyber Incident Response Planning
→8.5.2Service Design and Transition

Support(2 mappings)

7.1Cyber Incident Response Planning2 targets
→5.3Determining and Evaluating Audit Programme Risks
→8.5.2Service Design and Transition

Performance evaluation(1 mappings)

9.2Internal Audit
→6.3Information security awareness, education and training

Related Comparisons

Other ISO 45001:2018 comparisons

ISO 45001:2018 vs BRCGS Global Standard for Food Safety Issue 96 mappingsISO 45001:2018 vs PIC/S Guide to Good Manufacturing Practice for Medicinal Products6 mappingsISO 45001:2018 vs ICH E6(R3) - Good Clinical Practice6 mappingsISO 45001:2018 vs FDA Quality Management System Regulation (QMSR)6 mappingsISO 45001:2018 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements6 mappingsISO 45001:2018 vs IEC 62304:2015 Medical Device Software Lifecycle Processes6 mappingsISO 45001:2018 vs ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories6 mappingsISO 45001:2018 vs ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence6 mappings

Other ISO 13485:2016 comparisons

PIC/S Guide to Good Manufacturing Practice for Medicinal Products vs ISO 13485:20164 mappingsICH E6(R3) - Good Clinical Practice vs ISO 13485:20164 mappingsFDA Quality Management System Regulation (QMSR) vs ISO 13485:20164 mappingsISO 20000-1 vs ISO 13485:20164 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs ISO 13485:20164 mappingsISO 14001 vs ISO 13485:20164 mappingsASIS SPC.1-2009 - Organizational Resilience Standard vs ISO 13485:20164 mappingsAS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence vs ISO 13485:20164 mappings

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

ISO 45001:2018 has 37 controls across its framework, while ISO 13485:2016 covers 60 controls. Direct mapping analysis identifies 5 overlapping controls (14% coverage). The frameworks diverge most significantly in Planning, where 8 ISO 45001:2018 controls have no direct ISO 13485:2016 equivalent.

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

Of 37 total ISO 45001:2018 controls, 5 map directly to ISO 13485:2016 controls — representing 14% coverage. The remaining 32 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 45001:2018 to ISO 13485:2016?

32 ISO 45001:2018 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Planning with 8 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 45001:2018 and ISO 13485:2016?

The domain with the highest gap count is Planning (8 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.