ISO 15189:2022 - Medical Laboratories Requirements for Quality and CompetencevsFDA Quality Management System Regulation (QMSR)
See exactly how ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls map to FDA Quality Management System Regulation (QMSR). 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 FDA Quality Management System Regulation (QMSR) with 9% coverage across 7 directly mapped controls. Analysis of 77 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls identifies 70 compliance gaps — primarily concentrated in Clause 7: Process Requirements.
Source: TheArtOfService Knowledge Graph | 77 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 8 of 8 mapped controls across 6 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Resource Requirements(2 mappings)
Management System(2 mappings)
Annex A(1 mappings)
Clause 5: Structural and Governance Requirements(1 mappings)
Clause 7: Process Requirements(1 mappings)
Clause 8: Management System Requirements(1 mappings)
Related Comparisons
Other ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
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What are the key differences between ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence and FDA Quality Management System Regulation (QMSR)?
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence has 77 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 7 overlapping controls (9% 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 FDA Quality Management System Regulation (QMSR) equivalent.
How many controls map between ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence and FDA Quality Management System Regulation (QMSR)?
Of 77 total ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls, 7 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 9% coverage. The remaining 70 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 FDA Quality Management System Regulation (QMSR)?
70 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). 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 FDA Quality Management System Regulation (QMSR)?
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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