ISO 15189:2022 — Medical Laboratories Requirements for Quality and CompetencevsPIC/S Guide to Good Manufacturing Practice for Medicinal Products
See exactly how ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls map to PIC/S Guide to Good Manufacturing Practice for Medicinal Products. 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 PIC/S Guide to Good Manufacturing Practice for Medicinal Products with 20% coverage across 13 directly mapped controls. Analysis of 64 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls identifies 51 compliance gaps — primarily concentrated in Clause 7: Process Requirements.
Source: TheArtOfService Knowledge Graph | 64 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 20 of 29 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Clause 5: Structural and Governance Requirements(8 mappings)
Clause 6: Resource Requirements(12 mappings)
+9 more mappings
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Related Comparisons
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What are the key differences between ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence has 64 controls across its framework, while PIC/S Guide to Good Manufacturing Practice for Medicinal Products covers 17 controls. Direct mapping analysis identifies 13 overlapping controls (20% 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 PIC/S Guide to Good Manufacturing Practice for Medicinal Products equivalent.
How many controls map between ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
Of 64 total ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls, 13 map directly to PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls — representing 20% coverage. The remaining 51 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 PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
51 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls have no direct equivalent in PIC/S Guide to Good Manufacturing Practice for Medicinal Products. 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 PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
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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