ISO 45001vsICH Q10 - Pharmaceutical Quality System
See exactly how ISO 45001 controls map to ICH Q10 - Pharmaceutical Quality System. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 45001 maps to ICH Q10 - Pharmaceutical Quality System with 3% coverage across 1 directly mapped controls. Analysis of 39 ISO 45001 controls identifies 38 compliance gaps — primarily concentrated in ISO 45001: OH&S Policy & Planning.
Source: TheArtOfService Knowledge Graph | 39 controls analysed | 700 frameworks | 323K+ cross-framework mappings
Control Mappings
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ISO 45001: Performance & Improvement(1 mappings)
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What are the key differences between ISO 45001 and ICH Q10 - Pharmaceutical Quality System?
ISO 45001 has 39 controls across its framework, while ICH Q10 - Pharmaceutical Quality System covers 6 controls. Direct mapping analysis identifies 1 overlapping controls (3% coverage). The frameworks diverge most significantly in ISO 45001: OH&S Policy & Planning, where 5 ISO 45001 controls have no direct ICH Q10 - Pharmaceutical Quality System equivalent.
How many controls map between ISO 45001 and ICH Q10 - Pharmaceutical Quality System?
Of 39 total ISO 45001 controls, 1 map directly to ICH Q10 - Pharmaceutical Quality System controls — representing 3% coverage. The remaining 38 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 45001 to ICH Q10 - Pharmaceutical Quality System?
38 ISO 45001 controls have no direct equivalent in ICH Q10 - Pharmaceutical Quality System. The highest concentration of gaps is in ISO 45001: OH&S Policy & Planning with 5 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 45001 and ICH Q10 - Pharmaceutical Quality System?
The domain with the highest gap count is ISO 45001: OH&S Policy & Planning (5 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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