21 CFR Part 58 — Good Laboratory Practice (GLP)vsISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
See exactly how 21 CFR Part 58 — Good Laboratory Practice (GLP) controls map to ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
21 CFR Part 58 — Good Laboratory Practice (GLP) maps to ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence with 10% coverage across 3 directly mapped controls. Analysis of 31 21 CFR Part 58 — Good Laboratory Practice (GLP) controls identifies 28 compliance gaps — primarily concentrated in Test Articles and Protocol (Subparts F & G).
Source: TheArtOfService Knowledge Graph | 31 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 9 of 9 mapped controls across 2 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
General Provisions (Subpart A)(6 mappings)
Facilities (Subpart C)(3 mappings)
Related Comparisons
Other 21 CFR Part 58 — Good Laboratory Practice (GLP) comparisons
Other ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence comparisons
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What are the key differences between 21 CFR Part 58 — Good Laboratory Practice (GLP) and ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence?
21 CFR Part 58 — Good Laboratory Practice (GLP) has 31 controls across its framework, while ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence covers 64 controls. Direct mapping analysis identifies 3 overlapping controls (10% coverage). The frameworks diverge most significantly in Test Articles and Protocol (Subparts F & G), where 5 21 CFR Part 58 — Good Laboratory Practice (GLP) controls have no direct ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence equivalent.
How many controls map between 21 CFR Part 58 — Good Laboratory Practice (GLP) and ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence?
Of 31 total 21 CFR Part 58 — Good Laboratory Practice (GLP) controls, 3 map directly to ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls — representing 10% coverage. The remaining 28 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping 21 CFR Part 58 — Good Laboratory Practice (GLP) to ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence?
28 21 CFR Part 58 — Good Laboratory Practice (GLP) controls have no direct equivalent in ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence. The highest concentration of gaps is in Test Articles and Protocol (Subparts F & G) 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 21 CFR Part 58 — Good Laboratory Practice (GLP) and ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence?
The domain with the highest gap count is Test Articles and Protocol (Subparts F & G) (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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