ISO 13485:2016vsISO 27005:2022
See exactly how ISO 13485:2016 controls map to ISO 27005:2022. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485:2016 maps to ISO 27005:2022 with 5% coverage across 4 directly mapped controls. Analysis of 83 ISO 13485:2016 controls identifies 79 compliance gaps — primarily concentrated in Product realization – ISO 13485:2016.
Source: TheArtOfService Knowledge Graph | 83 controls analysed | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 9 of 9 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
Quality management system – ISO 13485:2016(6 mappings)
Management responsibility – ISO 13485:2016(1 mappings)
Product realization – ISO 13485:2016(1 mappings)
Measurement, analysis and improvement – ISO 13485:2016(1 mappings)
Related Comparisons
Other ISO 13485:2016 comparisons
Other ISO 27005:2022 comparisons
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What are the key differences between ISO 13485:2016 and ISO 27005:2022?
ISO 13485:2016 has 83 controls across its framework, while ISO 27005:2022 covers 45 controls. Direct mapping analysis identifies 4 overlapping controls (5% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 32 ISO 13485:2016 controls have no direct ISO 27005:2022 equivalent.
How many controls map between ISO 13485:2016 and ISO 27005:2022?
Of 83 total ISO 13485:2016 controls, 4 map directly to ISO 27005:2022 controls — representing 5% coverage. The remaining 79 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 13485:2016 to ISO 27005:2022?
79 ISO 13485:2016 controls have no direct equivalent in ISO 27005:2022. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 32 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 13485:2016 and ISO 27005:2022?
The domain with the highest gap count is Product realization – ISO 13485:2016 (32 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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