ISO 13485:2016vsISO 41001:2018 - Facility Management Systems
See exactly how ISO 13485:2016 controls map to ISO 41001:2018 - Facility Management Systems. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485:2016 maps to ISO 41001:2018 - Facility Management Systems with 14% coverage across 12 directly mapped controls. Analysis of 83 ISO 13485:2016 controls identifies 71 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 24 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(9 mappings)
Measurement, analysis and improvement – ISO 13485:2016(3 mappings)
+4 more mappings
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Related Comparisons
Other ISO 13485:2016 comparisons
Other ISO 41001:2018 - Facility Management Systems comparisons
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What are the key differences between ISO 13485:2016 and ISO 41001:2018 - Facility Management Systems?
ISO 13485:2016 has 83 controls across its framework, while ISO 41001:2018 - Facility Management Systems covers 168 controls. Direct mapping analysis identifies 12 overlapping controls (14% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 24 ISO 13485:2016 controls have no direct ISO 41001:2018 - Facility Management Systems equivalent.
How many controls map between ISO 13485:2016 and ISO 41001:2018 - Facility Management Systems?
Of 83 total ISO 13485:2016 controls, 12 map directly to ISO 41001:2018 - Facility Management Systems controls — representing 14% coverage. The remaining 71 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 41001:2018 - Facility Management Systems?
71 ISO 13485:2016 controls have no direct equivalent in ISO 41001:2018 - Facility Management Systems. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 24 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 41001:2018 - Facility Management Systems?
The domain with the highest gap count is Product realization – ISO 13485:2016 (24 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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