ISO 15189:2022 - Medical Laboratories Requirements for Quality and CompetencevsICH Q10 - Pharmaceutical Quality System
See exactly how ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls map to ICH Q10 - Pharmaceutical Quality System. 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 ICH Q10 - Pharmaceutical Quality System with 17% coverage across 13 directly mapped controls. Analysis of 77 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 | 77 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 20 of 25 mapped controls across 6 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Resource Requirements(4 mappings)
Annex A(1 mappings)
Clause 5: Structural and Governance Requirements(8 mappings)
Clause 6: Resource Requirements(3 mappings)
Clause 7: Process Requirements(3 mappings)
Clause 8: Management System Requirements(1 mappings)
+5 more mappings
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Related Comparisons
Other ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
Other ICH Q10 - Pharmaceutical Quality System comparisons
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What are the key differences between ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence and ICH Q10 - Pharmaceutical Quality System?
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence has 77 controls across its framework, while ICH Q10 - Pharmaceutical Quality System covers 6 controls. Direct mapping analysis identifies 13 overlapping controls (17% coverage). The frameworks diverge most significantly in Clause 7: Process Requirements, where 18 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls have no direct ICH Q10 - Pharmaceutical Quality System equivalent.
How many controls map between ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence and ICH Q10 - Pharmaceutical Quality System?
Of 77 total ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls, 13 map directly to ICH Q10 - Pharmaceutical Quality System controls — representing 17% 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 ICH Q10 - Pharmaceutical Quality System?
64 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls have no direct equivalent in ICH Q10 - Pharmaceutical Quality System. The highest concentration of gaps is in Clause 7: Process Requirements with 18 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 ICH Q10 - Pharmaceutical Quality System?
The domain with the highest gap count is Clause 7: Process Requirements (18 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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