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.
Need this as a report you can hand to an assessor? A coverage crosswalk for this pair can be built to order.
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 23% coverage across 9 directly mapped controls. Analysis of 39 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls identifies 30 compliance gaps, primarily concentrated in Clause 6: Resource Requirements.
Source: TheArtOfService Knowledge Graph | 39 controls analysed | 686 frameworks | 306K+ cross-framework mappings
Control Mappings
Showing 19 of 19 mapped controls across 5 domains. Sign up to explore all 306K+ mappings across 686 frameworks.
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(4 mappings)
A ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence to ICH Q10 - Pharmaceutical Quality System crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which ICH Q10 - Pharmaceutical Quality System controls your existing ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence work already satisfies, which are real gaps, and the reasoning behind every claim so you can check it. One pair, $299, one time.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
- Every evidenced control, with the reasoning behind it
- Every gap, with what it requires
- Its level of review stated plainly, not a bare number
Why this page shows two different percentages. The 23% in the header counts how many ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many ICH Q10 - Pharmaceutical Quality System controls are actually evidenced, after a pass that argued against each mapping and kept only what survived. They answer different questions and they are not meant to agree.
A crosswalk narrows the work. It does not replace an audit, and your assessor may take a different view on individual controls. Mappings between frameworks are judgements, not text printed in either standard, which is why every claim in the report shows its reasoning. Questions go to support@theartofservice.com.
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 39 controls across its framework, while ICH Q10 - Pharmaceutical Quality System covers 6 controls. Direct mapping analysis identifies 9 overlapping controls (23% coverage). The frameworks diverge most significantly in Clause 6: Resource Requirements, where 8 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 39 total ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls, 9 map directly to ICH Q10 - Pharmaceutical Quality System controls, representing 23% coverage. The remaining 30 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?
30 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 6: Resource Requirements 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 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 6: Resource Requirements (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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