ISO 27701:2019vsISO 13485:2016
See exactly how ISO 27701:2019 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 27701:2019 maps to ISO 13485:2016 with 6% coverage across 8 directly mapped controls. Analysis of 136 ISO 27701:2019 controls identifies 128 compliance gaps — primarily concentrated in PIMS-specific guidance related to ISO/IEC 27002 – ISO 27701:2019.
Source: TheArtOfService Knowledge Graph | 136 controls analysed | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 10 of 10 mapped controls across 6 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
Clause 0 – ISO 27701:2019(1 mappings)
General – ISO 27701:2019(3 mappings)
PIMS-specific requirements related to ISO/IEC 27001 – ISO 27701:2019(3 mappings)
PIMS-specific guidance related to ISO/IEC 27002 – ISO 27701:2019(1 mappings)
Additional ISO/IEC 27002 guidance for PII controllers – ISO 27701:2019(1 mappings)
Additional ISO/IEC 27002 guidance for PII processors – ISO 27701:2019(1 mappings)
Related Comparisons
Other ISO 27701:2019 comparisons
Other ISO 13485:2016 comparisons
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What are the key differences between ISO 27701:2019 and ISO 13485:2016?
ISO 27701:2019 has 136 controls across its framework, while ISO 13485:2016 covers 83 controls. Direct mapping analysis identifies 8 overlapping controls (6% coverage). The frameworks diverge most significantly in PIMS-specific guidance related to ISO/IEC 27002 – ISO 27701:2019, where 48 ISO 27701:2019 controls have no direct ISO 13485:2016 equivalent.
How many controls map between ISO 27701:2019 and ISO 13485:2016?
Of 136 total ISO 27701:2019 controls, 8 map directly to ISO 13485:2016 controls — representing 6% coverage. The remaining 128 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 27701:2019 to ISO 13485:2016?
128 ISO 27701:2019 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in PIMS-specific guidance related to ISO/IEC 27002 – ISO 27701:2019 with 48 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 27701:2019 and ISO 13485:2016?
The domain with the highest gap count is PIMS-specific guidance related to ISO/IEC 27002 – ISO 27701:2019 (48 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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