ISO 13485:2016vsISO 31000:2018
See exactly how ISO 13485:2016 controls map to ISO 31000:2018. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485:2016 maps to ISO 31000:2018 with 13% coverage across 11 directly mapped controls. Analysis of 83 ISO 13485:2016 controls identifies 72 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 15 of 15 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Quality management system – ISO 13485:2016(5 mappings)
Product realization – ISO 13485:2016(10 mappings)
Related Comparisons
Other ISO 13485:2016 comparisons
Other ISO 31000:2018 comparisons
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What are the key differences between ISO 13485:2016 and ISO 31000:2018?
ISO 13485:2016 has 83 controls across its framework, while ISO 31000:2018 covers 57 controls. Direct mapping analysis identifies 11 overlapping controls (13% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 23 ISO 13485:2016 controls have no direct ISO 31000:2018 equivalent.
How many controls map between ISO 13485:2016 and ISO 31000:2018?
Of 83 total ISO 13485:2016 controls, 11 map directly to ISO 31000:2018 controls — representing 13% coverage. The remaining 72 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 31000:2018?
72 ISO 13485:2016 controls have no direct equivalent in ISO 31000:2018. 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 31000:2018?
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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