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Cross-Framework Mapping

ISO 31000:2018vsISO 13485:2016

See exactly how ISO 31000:2018 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.

15
Controls Mapped
17
Gaps Found
6%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 31000:2018 maps to ISO 13485:2016 with 6% coverage across 0 directly mapped controls. Analysis of 32 ISO 31000:2018 controls identifies 32 compliance gaps — primarily concentrated in Process.

Source: TheArtOfService Knowledge Graph | 32 controls analysed | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 15 of 15 mapped controls across 2 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

Framework – ISO 31000:2018(10 mappings)

iso-31000-2018::5.1General
→iso-13485-2016::4.1General requirements
iso-31000-2018::5.4Design9 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

Process – ISO 31000:2018(5 mappings)

iso-31000-2018::6.1General
→iso-13485-2016::4.1General requirements
iso-31000-2018::6.2Communication and consultation
→iso-13485-2016::7.2.3Communication
iso-31000-2018::6.3.1General
→iso-13485-2016::4.1General requirements
iso-31000-2018::6.4.1General
→iso-13485-2016::4.1General requirements
iso-31000-2018::6.5.1General
→iso-13485-2016::4.1General requirements

Related Comparisons

Other ISO 31000:2018 comparisons

ISO 31000:2018 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements3 mappingsISO 31000:2018 vs ISO 134853 mappingsISO 31000:2018 vs Virginia CDPA2 mappingsISO 31000:2018 vs Vietnam PDPD2 mappingsISO 31000:2018 vs Uruguay DPL2 mappingsISO 31000:2018 vs Turkey KVKK2 mappingsISO 31000:2018 vs Texas Data Privacy Act2 mappingsISO 31000:2018 vs Taiwan PDPA2 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 45001:2018 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 mappings

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What are the key differences between ISO 31000:2018 and ISO 13485:2016?

ISO 31000:2018 has 32 controls across its framework, while ISO 13485:2016 covers 60 controls. Direct mapping analysis identifies 0 overlapping controls (6% coverage). The frameworks diverge most significantly in Process, where 14 ISO 31000:2018 controls have no direct ISO 13485:2016 equivalent.

How many controls map between ISO 31000:2018 and ISO 13485:2016?

Of 32 total ISO 31000:2018 controls, 0 map directly to ISO 13485:2016 controls — representing 6% 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 31000:2018 to ISO 13485:2016?

32 ISO 31000:2018 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Process with 14 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 31000:2018 and ISO 13485:2016?

The domain with the highest gap count is Process (14 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.