ISO 15189:2022 - Medical Laboratories Requirements for Quality and CompetencevsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 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 15189:2022 - Medical Laboratories Requirements for Quality and Competence maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 18% coverage across 13 directly mapped controls. Analysis of 89 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls identifies 64 compliance gaps — primarily concentrated in Clause 7: Process Requirements.
Source: TheArtOfService Knowledge Graph | 89 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 20 of 44 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Resource Requirements(12 mappings)
Management System(1 mappings)
Clause 5: Structural and Governance Requirements(7 mappings)
+24 more mappings
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Related Comparisons
Other ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence and IEC 62304:2015 Medical Device Software Lifecycle Processes?
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence has 89 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 13 overlapping controls (18% coverage). The frameworks diverge most significantly in Clause 7: Process Requirements, where 19 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 89 total ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls, 13 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 18% coverage. The remaining 64 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence to IEC 62304:2015 Medical Device Software Lifecycle Processes?
64 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Clause 7: Process Requirements with 19 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 15189:2022 - Medical Laboratories Requirements for Quality and Competence and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Clause 7: Process Requirements (19 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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