ISO 9001:2015vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how ISO 9001:2015 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 9001:2015 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 12% coverage across 0 directly mapped controls. Analysis of 56 ISO 9001:2015 controls identifies 56 compliance gaps — primarily concentrated in Operation.
Source: TheArtOfService Knowledge Graph | 56 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
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Context of the organization – ISO 9001:2015(1 mappings)
Related Comparisons
Other ISO 9001:2015 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between ISO 9001:2015 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
ISO 9001:2015 has 56 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 0 overlapping controls (12% coverage). The frameworks diverge most significantly in Operation, where 22 ISO 9001:2015 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between ISO 9001:2015 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 56 total ISO 9001:2015 controls, 0 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 12% coverage. The remaining 56 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 9001:2015 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
56 ISO 9001:2015 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Operation with 22 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 9001:2015 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Operation (22 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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