ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competencevs21 CFR Part 211 - Current Good Manufacturing Practice
See exactly how ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls map to 21 CFR Part 211 - Current Good Manufacturing Practice. 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 21 CFR Part 211 - Current Good Manufacturing Practice with 16% coverage across 11 directly mapped controls. Analysis of 89 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls identifies 66 compliance gaps — primarily concentrated in Clause 7: Process Requirements.
Source: TheArtOfService Knowledge Graph | 89 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 19 of 19 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Resource Requirements(2 mappings)
Management System(3 mappings)
Annex A(1 mappings)
Clause 5: Structural and Governance Requirements(2 mappings)
Clause 6: Resource Requirements(11 mappings)
Related Comparisons
Other ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
Other 21 CFR Part 211 - Current Good Manufacturing Practice comparisons
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What are the key differences between ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence and 21 CFR Part 211 - Current Good Manufacturing Practice?
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence has 89 controls across its framework, while 21 CFR Part 211 - Current Good Manufacturing Practice covers 78 controls. Direct mapping analysis identifies 11 overlapping controls (16% coverage). The frameworks diverge most significantly in Clause 7: Process Requirements, where 19 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls have no direct 21 CFR Part 211 - Current Good Manufacturing Practice equivalent.
How many controls map between ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence and 21 CFR Part 211 - Current Good Manufacturing Practice?
Of 89 total ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls, 11 map directly to 21 CFR Part 211 - Current Good Manufacturing Practice controls — representing 16% coverage. The remaining 66 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 21 CFR Part 211 - Current Good Manufacturing Practice?
66 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls have no direct equivalent in 21 CFR Part 211 - Current Good Manufacturing Practice. The highest concentration of gaps is in Clause 7: Process Requirements with 19 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 21 CFR Part 211 - Current Good Manufacturing Practice?
The domain with the highest gap count is Clause 7: Process Requirements (19 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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