ISO/IEC 42001:2023vsISO 13485:2016
See exactly how ISO/IEC 42001:2023 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO/IEC 42001:2023 maps to ISO 13485:2016 with 8% coverage across 6 directly mapped controls. Analysis of 80 ISO/IEC 42001:2023 controls identifies 74 compliance gaps — primarily concentrated in Clause A – ISO/IEC 42001:2023.
Source: TheArtOfService Knowledge Graph | 80 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 6 of 6 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Annex A AIMS controls - A.4 Resources for AI systems(1 mappings)
Annex A AIMS controls - A.8 Information for interested parties of AI systems(1 mappings)
Planning – ISO/IEC 42001:2023(1 mappings)
Support – ISO/IEC 42001:2023(1 mappings)
Performance evaluation – ISO/IEC 42001:2023(2 mappings)
Related Comparisons
Other ISO/IEC 42001:2023 comparisons
Other ISO 13485:2016 comparisons
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What are the key differences between ISO/IEC 42001:2023 and ISO 13485:2016?
ISO/IEC 42001:2023 has 80 controls across its framework, while ISO 13485:2016 covers 83 controls. Direct mapping analysis identifies 6 overlapping controls (8% coverage). The frameworks diverge most significantly in Clause A – ISO/IEC 42001:2023, where 9 ISO/IEC 42001:2023 controls have no direct ISO 13485:2016 equivalent.
How many controls map between ISO/IEC 42001:2023 and ISO 13485:2016?
Of 80 total ISO/IEC 42001:2023 controls, 6 map directly to ISO 13485:2016 controls — representing 8% coverage. The remaining 74 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO/IEC 42001:2023 to ISO 13485:2016?
74 ISO/IEC 42001:2023 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Clause A – ISO/IEC 42001:2023 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/IEC 42001:2023 and ISO 13485:2016?
The domain with the highest gap count is Clause A – ISO/IEC 42001:2023 (9 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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