ISO 13485vsISO 28001:2007 Supply Chain Security Management
See exactly how ISO 13485 controls map to ISO 28001:2007 Supply Chain Security Management. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485 maps to ISO 28001:2007 Supply Chain Security Management with 14% coverage across 5 directly mapped controls. Analysis of 44 ISO 13485 controls identifies 39 compliance gaps — primarily concentrated in Product Realisation.
Source: TheArtOfService Knowledge Graph | 44 controls analysed | 706 frameworks | 324K+ cross-framework mappings
Control Mappings
Showing 5 of 5 mapped controls across 3 domains. Sign up to explore all 324K+ mappings across 706 frameworks.
ISO 13485: Patient Data Protection(1 mappings)
ISO 13485: Administrative Safeguards(3 mappings)
ISO 13485: Physical Safeguards(1 mappings)
Related Comparisons
Other ISO 13485 comparisons
Other ISO 28001:2007 Supply Chain Security Management comparisons
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What are the key differences between ISO 13485 and ISO 28001:2007 Supply Chain Security Management?
ISO 13485 has 44 controls across its framework, while ISO 28001:2007 Supply Chain Security Management covers 36 controls. Direct mapping analysis identifies 5 overlapping controls (14% coverage). The frameworks diverge most significantly in Product Realisation, where 7 ISO 13485 controls have no direct ISO 28001:2007 Supply Chain Security Management equivalent.
How many controls map between ISO 13485 and ISO 28001:2007 Supply Chain Security Management?
Of 44 total ISO 13485 controls, 5 map directly to ISO 28001:2007 Supply Chain Security Management controls — representing 14% coverage. The remaining 39 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 13485 to ISO 28001:2007 Supply Chain Security Management?
39 ISO 13485 controls have no direct equivalent in ISO 28001:2007 Supply Chain Security Management. The highest concentration of gaps is in Product Realisation with 7 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 and ISO 28001:2007 Supply Chain Security Management?
The domain with the highest gap count is Product Realisation (7 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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