ISO 15189:2022 - Medical Laboratories Requirements for Quality and CompetencevsISO 10005:2005
See exactly how ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls map to ISO 10005:2005. 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 10005:2005 with 5% coverage across 4 directly mapped controls. Analysis of 77 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 | 77 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 4 of 4 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Clause 4: General Requirements(1 mappings)
Clause 8: Management System Requirements(3 mappings)
Related Comparisons
Other ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
Other ISO 10005:2005 comparisons
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What are the key differences between ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence and ISO 10005:2005?
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence has 77 controls across its framework, while ISO 10005:2005 covers 27 controls. Direct mapping analysis identifies 4 overlapping controls (5% 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 10005:2005 equivalent.
How many controls map between ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence and ISO 10005:2005?
Of 77 total ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls, 4 map directly to ISO 10005:2005 controls — representing 5% 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 10005:2005?
73 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls have no direct equivalent in ISO 10005:2005. 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 10005:2005?
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.
Related Resources
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