ISO 19011vsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
See exactly how ISO 19011 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:
ISO 19011 maps to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence with 18% coverage across 6 directly mapped controls. Analysis of 34 ISO 19011 controls identifies 28 compliance gaps — primarily concentrated in Audit Principles.
Source: TheArtOfService Knowledge Graph | 34 controls analysed | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 16 of 16 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
Audit Principles(1 mappings)
Audit Process(12 mappings)
ISO 19011: Performance Evaluation(3 mappings)
Related Comparisons
Other ISO 19011 comparisons
Other ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
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What are the key differences between ISO 19011 and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
ISO 19011 has 34 controls across its framework, while ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence covers 77 controls. Direct mapping analysis identifies 6 overlapping controls (18% coverage). The frameworks diverge most significantly in Audit Principles, where 6 ISO 19011 controls have no direct ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence equivalent.
How many controls map between ISO 19011 and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
Of 34 total ISO 19011 controls, 6 map directly to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls — representing 18% 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 ISO 19011 to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
28 ISO 19011 controls have no direct equivalent in ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. The highest concentration of gaps is in Audit Principles with 6 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 19011 and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
The domain with the highest gap count is Audit Principles (6 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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