ISO 13485:2016vsISO 9001
See exactly how ISO 13485:2016 controls map to ISO 9001. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485:2016 maps to ISO 9001 with 18% coverage across 15 directly mapped controls. Analysis of 83 ISO 13485:2016 controls identifies 68 compliance gaps — primarily concentrated in Product realization – ISO 13485:2016.
Source: TheArtOfService Knowledge Graph | 83 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 17 of 17 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Management responsibility – ISO 13485:2016(3 mappings)
Product realization – ISO 13485:2016(13 mappings)
Measurement, analysis and improvement – ISO 13485:2016(1 mappings)
Related Comparisons
Other ISO 13485:2016 comparisons
Other ISO 9001 comparisons
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What are the key differences between ISO 13485:2016 and ISO 9001?
ISO 13485:2016 has 83 controls across its framework, while ISO 9001 covers 48 controls. Direct mapping analysis identifies 15 overlapping controls (18% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 22 ISO 13485:2016 controls have no direct ISO 9001 equivalent.
How many controls map between ISO 13485:2016 and ISO 9001?
Of 83 total ISO 13485:2016 controls, 15 map directly to ISO 9001 controls — representing 18% coverage. The remaining 68 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 9001?
68 ISO 13485:2016 controls have no direct equivalent in ISO 9001. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 22 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 9001?
The domain with the highest gap count is Product realization – ISO 13485:2016 (22 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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