ISO 15189:2022 — Medical Laboratories Requirements for Quality and CompetencevsISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
See exactly how ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls map to ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories. 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/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories with 19% coverage across 12 directly mapped controls. Analysis of 64 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls identifies 52 compliance gaps — primarily concentrated in Clause 7: Process Requirements.
Source: TheArtOfService Knowledge Graph | 64 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 20 of 24 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Clause 5: Structural and Governance Requirements(8 mappings)
Clause 6: Resource Requirements(8 mappings)
Clause 7: Process Requirements(1 mappings)
Clause 8: Management System Requirements(3 mappings)
+4 more mappings
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Related Comparisons
Other ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence comparisons
Other ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories comparisons
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What are the key differences between ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence and ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories?
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence has 64 controls across its framework, while ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories covers 65 controls. Direct mapping analysis identifies 12 overlapping controls (19% 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 ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories equivalent.
How many controls map between ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence and ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories?
Of 64 total ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls, 12 map directly to ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories controls — representing 19% 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 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence to ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories?
52 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls have no direct equivalent in ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories. 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 ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories?
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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