ISO/IEC 27004:2016vsISO 13485:2016
See exactly how ISO/IEC 27004:2016 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO/IEC 27004:2016 maps to ISO 13485:2016 with 10% coverage across 3 directly mapped controls. Analysis of 30 ISO/IEC 27004:2016 controls identifies 42 compliance gaps — primarily concentrated in Annex Examples.
Source: TheArtOfService Knowledge Graph | 30 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Operation(1 mappings)
Clause 8: Processes(1 mappings)
Reporting(1 mappings)
Related Comparisons
Other ISO/IEC 27004:2016 comparisons
Other ISO 13485:2016 comparisons
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What are the key differences between ISO/IEC 27004:2016 and ISO 13485:2016?
ISO/IEC 27004:2016 has 30 controls across its framework, while ISO 13485:2016 covers 60 controls. Direct mapping analysis identifies 3 overlapping controls (10% coverage). The frameworks diverge most significantly in Annex Examples, where 6 ISO/IEC 27004:2016 controls have no direct ISO 13485:2016 equivalent.
How many controls map between ISO/IEC 27004:2016 and ISO 13485:2016?
Of 30 total ISO/IEC 27004:2016 controls, 3 map directly to ISO 13485:2016 controls — representing 10% coverage. The remaining 42 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO/IEC 27004:2016 to ISO 13485:2016?
42 ISO/IEC 27004:2016 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Annex Examples with 6 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 27004:2016 and ISO 13485:2016?
The domain with the highest gap count is Annex Examples (6 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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