ISO 13485:2016vsISO 39001:2012 - Road Traffic Safety Management
See exactly how ISO 13485:2016 controls map to ISO 39001:2012 - Road Traffic Safety Management. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485:2016 maps to ISO 39001:2012 - Road Traffic Safety Management with 16% coverage across 13 directly mapped controls. Analysis of 83 ISO 13485:2016 controls identifies 70 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 20 of 25 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Quality management system – ISO 13485:2016(1 mappings)
Management responsibility – ISO 13485:2016(7 mappings)
Product realization – ISO 13485:2016(10 mappings)
Measurement, analysis and improvement – ISO 13485:2016(2 mappings)
+5 more mappings
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Related Comparisons
Other ISO 13485:2016 comparisons
Other ISO 39001:2012 - Road Traffic Safety Management comparisons
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What are the key differences between ISO 13485:2016 and ISO 39001:2012 - Road Traffic Safety Management?
ISO 13485:2016 has 83 controls across its framework, while ISO 39001:2012 - Road Traffic Safety Management covers 169 controls. Direct mapping analysis identifies 13 overlapping controls (16% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 23 ISO 13485:2016 controls have no direct ISO 39001:2012 - Road Traffic Safety Management equivalent.
How many controls map between ISO 13485:2016 and ISO 39001:2012 - Road Traffic Safety Management?
Of 83 total ISO 13485:2016 controls, 13 map directly to ISO 39001:2012 - Road Traffic Safety Management controls — representing 16% coverage. The remaining 70 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 39001:2012 - Road Traffic Safety Management?
70 ISO 13485:2016 controls have no direct equivalent in ISO 39001:2012 - Road Traffic Safety Management. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 23 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 39001:2012 - Road Traffic Safety Management?
The domain with the highest gap count is Product realization – ISO 13485:2016 (23 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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