ISO 15189:2022 — Medical Laboratories Requirements for Quality and CompetencevsISO 19011
See exactly how ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls map to ISO 19011. 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 ISO 19011 with 18% coverage across 16 directly mapped controls. Analysis of 89 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls identifies 73 compliance gaps — primarily concentrated in Clause 7: Process Requirements.
Source: TheArtOfService Knowledge Graph | 89 controls analysed | 769 frameworks | 815K+ cross-framework mappings
Control Mappings
Showing 20 of 24 mapped controls across 6 domains. Sign up to explore all 815K+ mappings across 769 frameworks.
General Requirements(2 mappings)
Resource Requirements(6 mappings)
Management System(1 mappings)
Clause 5: Structural and Governance Requirements(6 mappings)
Clause 6: Resource Requirements(5 mappings)
+4 more mappings
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Related Comparisons
Other ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence comparisons
Other ISO 19011 comparisons
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What are the key differences between ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence and ISO 19011?
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence has 89 controls across its framework, while ISO 19011 covers 42 controls. Direct mapping analysis identifies 16 overlapping controls (18% 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 ISO 19011 equivalent.
How many controls map between ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence and ISO 19011?
Of 89 total ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls, 16 map directly to ISO 19011 controls — representing 18% coverage. The remaining 73 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 ISO 19011?
73 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls have no direct equivalent in ISO 19011. 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 ISO 19011?
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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