ISO/IEC 38500:2024vsISO 13485:2016
See exactly how ISO/IEC 38500:2024 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO/IEC 38500:2024 maps to ISO 13485:2016 with 23% coverage across 15 directly mapped controls. Analysis of 66 ISO/IEC 38500:2024 controls identifies 51 compliance gaps — primarily concentrated in Principles for the governance of IT – ISO/IEC 38500:2024.
Source: TheArtOfService Knowledge Graph | 66 controls analysed | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 17 of 17 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
Good governance of IT – ISO/IEC 38500:2024(1 mappings)
Principles for the governance of IT – ISO/IEC 38500:2024(4 mappings)
Model for the governance of IT – ISO/IEC 38500:2024(5 mappings)
Framework for the governance of IT – ISO/IEC 38500:2024(7 mappings)
Related Comparisons
Other ISO/IEC 38500:2024 comparisons
Other ISO 13485:2016 comparisons
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What are the key differences between ISO/IEC 38500:2024 and ISO 13485:2016?
ISO/IEC 38500:2024 has 66 controls across its framework, while ISO 13485:2016 covers 83 controls. Direct mapping analysis identifies 15 overlapping controls (23% coverage). The frameworks diverge most significantly in Principles for the governance of IT – ISO/IEC 38500:2024, where 40 ISO/IEC 38500:2024 controls have no direct ISO 13485:2016 equivalent.
How many controls map between ISO/IEC 38500:2024 and ISO 13485:2016?
Of 66 total ISO/IEC 38500:2024 controls, 15 map directly to ISO 13485:2016 controls — representing 23% coverage. The remaining 51 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO/IEC 38500:2024 to ISO 13485:2016?
51 ISO/IEC 38500:2024 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Principles for the governance of IT – ISO/IEC 38500:2024 with 40 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 38500:2024 and ISO 13485:2016?
The domain with the highest gap count is Principles for the governance of IT – ISO/IEC 38500:2024 (40 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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