21 CFR Part 211 — Current Good Manufacturing PracticevsISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice 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 211 — Current Good Manufacturing Practice maps to ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence with 9% coverage across 5 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 52 compliance gaps — primarily concentrated in Subpart J — Records and Reports.
Source: TheArtOfService Knowledge Graph | 57 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 13 of 13 mapped controls across 5 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Subpart A — General Provisions(3 mappings)
Subpart C — Buildings and Facilities(3 mappings)
Subpart F — Production and Process Controls(3 mappings)
Subpart I — Laboratory Controls(3 mappings)
Subpart J — Records and Reports(1 mappings)
Related Comparisons
Other 21 CFR Part 211 — Current Good Manufacturing Practice 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 211 — Current Good Manufacturing Practice and ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence?
21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence covers 64 controls. Direct mapping analysis identifies 5 overlapping controls (9% coverage). The frameworks diverge most significantly in Subpart J — Records and Reports, where 8 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence equivalent.
How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence?
Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 5 map directly to ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls — representing 9% coverage. The remaining 52 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 211 — Current Good Manufacturing Practice to ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence?
52 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence. The highest concentration of gaps is in Subpart J — Records and Reports 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 21 CFR Part 211 — Current Good Manufacturing Practice and ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence?
The domain with the highest gap count is Subpart J — Records and Reports (8 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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