ISO 9001vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how ISO 9001 controls map to IEC 62304:2015 Medical Device Software Lifecycle Processes. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 9001 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 17% coverage across 4 directly mapped controls. Analysis of 23 ISO 9001 controls identifies 19 compliance gaps — primarily concentrated in ISO 9001: Leadership & Planning.
Source: TheArtOfService Knowledge Graph | 23 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 8 of 8 mapped controls across 2 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
ISO 9001: Performance Evaluation(6 mappings)
ISO 9001: Improvement(2 mappings)
Related Comparisons
Other ISO 9001 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between ISO 9001 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
ISO 9001 has 23 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 30 controls. Direct mapping analysis identifies 4 overlapping controls (17% coverage). The frameworks diverge most significantly in ISO 9001: Leadership & Planning, where 9 ISO 9001 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between ISO 9001 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 23 total ISO 9001 controls, 4 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 17% coverage. The remaining 19 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 9001 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
19 ISO 9001 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in ISO 9001: Leadership & Planning with 9 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 9001 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is ISO 9001: Leadership & Planning (9 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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