ISO 9001:2015vsISO 13485:2016
See exactly how ISO 9001:2015 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 9001:2015 maps to ISO 13485:2016 with 39% coverage across 28 directly mapped controls. Analysis of 71 ISO 9001:2015 controls identifies 43 compliance gaps — primarily concentrated in Operation – ISO 9001:2015.
Source: TheArtOfService Knowledge Graph | 71 controls analysed | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 20 of 34 mapped controls across 7 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
Clause 0 – ISO 9001:2015(3 mappings)
Improvement – ISO 9001:2015(1 mappings)
Leadership – ISO 9001:2015(2 mappings)
Planning – ISO 9001:2015(2 mappings)
Support – ISO 9001:2015(2 mappings)
Operation – ISO 9001:2015(10 mappings)
+14 more mappings
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Related Comparisons
Other ISO 9001:2015 comparisons
Other ISO 13485:2016 comparisons
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What are the key differences between ISO 9001:2015 and ISO 13485:2016?
ISO 9001:2015 has 71 controls across its framework, while ISO 13485:2016 covers 83 controls. Direct mapping analysis identifies 28 overlapping controls (39% coverage). The frameworks diverge most significantly in Operation – ISO 9001:2015, where 14 ISO 9001:2015 controls have no direct ISO 13485:2016 equivalent.
How many controls map between ISO 9001:2015 and ISO 13485:2016?
Of 71 total ISO 9001:2015 controls, 28 map directly to ISO 13485:2016 controls — representing 39% coverage. The remaining 43 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 9001:2015 to ISO 13485:2016?
43 ISO 9001:2015 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Operation – ISO 9001:2015 with 14 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 9001:2015 and ISO 13485:2016?
The domain with the highest gap count is Operation – ISO 9001:2015 (14 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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