ISO 37001:2016vsISO 13485:2016
See exactly how ISO 37001:2016 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 37001:2016 maps to ISO 13485:2016 with 10% coverage across 4 directly mapped controls. Analysis of 41 ISO 37001:2016 controls identifies 37 compliance gaps — primarily concentrated in Operation – ISO 37001:2016.
Source: TheArtOfService Knowledge Graph | 41 controls analysed | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 4 of 4 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
Support – ISO 37001:2016(2 mappings)
Performance evaluation – ISO 37001:2016(2 mappings)
Related Comparisons
Other ISO 37001:2016 comparisons
Other ISO 13485:2016 comparisons
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What are the key differences between ISO 37001:2016 and ISO 13485:2016?
ISO 37001:2016 has 41 controls across its framework, while ISO 13485:2016 covers 83 controls. Direct mapping analysis identifies 4 overlapping controls (10% coverage). The frameworks diverge most significantly in Operation – ISO 37001:2016, where 10 ISO 37001:2016 controls have no direct ISO 13485:2016 equivalent.
How many controls map between ISO 37001:2016 and ISO 13485:2016?
Of 41 total ISO 37001:2016 controls, 4 map directly to ISO 13485:2016 controls — representing 10% coverage. The remaining 37 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 37001:2016 to ISO 13485:2016?
37 ISO 37001:2016 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Operation – ISO 37001:2016 with 10 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 37001:2016 and ISO 13485:2016?
The domain with the highest gap count is Operation – ISO 37001:2016 (10 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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