IEC 62443vsISO 13485
See exactly how IEC 62443 controls map to ISO 13485. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
IEC 62443 maps to ISO 13485 with 5% coverage across 4 directly mapped controls. Analysis of 81 IEC 62443 controls identifies 77 compliance gaps — primarily concentrated in 62443-3-3 System Security Requirements.
Source: TheArtOfService Knowledge Graph | 81 controls analysed | 700 frameworks | 323K+ cross-framework mappings
Control Mappings
Showing 11 of 11 mapped controls across 2 domains. Sign up to explore all 323K+ mappings across 700 frameworks.
IEC 62443: Access Management(10 mappings)
IEC 62443: Supply Chain & Configuration(1 mappings)
Related Comparisons
Other IEC 62443 comparisons
Other ISO 13485 comparisons
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What are the key differences between IEC 62443 and ISO 13485?
IEC 62443 has 81 controls across its framework, while ISO 13485 covers 44 controls. Direct mapping analysis identifies 4 overlapping controls (5% coverage). The frameworks diverge most significantly in 62443-3-3 System Security Requirements, where 24 IEC 62443 controls have no direct ISO 13485 equivalent.
How many controls map between IEC 62443 and ISO 13485?
Of 81 total IEC 62443 controls, 4 map directly to ISO 13485 controls — representing 5% coverage. The remaining 77 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping IEC 62443 to ISO 13485?
77 IEC 62443 controls have no direct equivalent in ISO 13485. The highest concentration of gaps is in 62443-3-3 System Security Requirements 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 IEC 62443 and ISO 13485?
The domain with the highest gap count is 62443-3-3 System Security Requirements (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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