IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsISO 8000 - Data Quality
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to ISO 8000 - Data Quality. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
IEC 62304:2015 Medical Device Software Lifecycle Processes maps to ISO 8000 - Data Quality with 9% coverage across 6 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 44 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 33 controls analysed | 700 frameworks | 323K+ cross-framework mappings
Control Mappings
Showing 12 of 12 mapped controls across 5 domains. Sign up to explore all 323K+ mappings across 700 frameworks.
Requirements(2 mappings)
Clause 5 - Software Development Process(4 mappings)
Design(2 mappings)
Risk Management(2 mappings)
Clause 7 - Software Risk Management Process(2 mappings)
Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other ISO 8000 - Data Quality comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and ISO 8000 - Data Quality?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while ISO 8000 - Data Quality covers 29 controls. Direct mapping analysis identifies 6 overlapping controls (9% coverage). The frameworks diverge most significantly in Clause 9 - Software Problem Resolution Process, where 8 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct ISO 8000 - Data Quality equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and ISO 8000 - Data Quality?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 6 map directly to ISO 8000 - Data Quality controls — representing 9% coverage. The remaining 44 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping IEC 62304:2015 Medical Device Software Lifecycle Processes to ISO 8000 - Data Quality?
44 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in ISO 8000 - Data Quality. The highest concentration of gaps is in Clause 9 - Software Problem Resolution Process with 8 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 62304:2015 Medical Device Software Lifecycle Processes and ISO 8000 - Data Quality?
The domain with the highest gap count is Clause 9 - Software Problem Resolution Process (8 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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