ISO 9001:2015vsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
See exactly how ISO 9001:2015 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 9001:2015 maps to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence with 1% coverage across 0 directly mapped controls. Analysis of 71 ISO 9001:2015 controls identifies 56 compliance gaps — primarily concentrated in Operation.
Source: TheArtOfService Knowledge Graph | 71 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 1 of 1 mapped controls across 1 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Planning – ISO 9001:2015(1 mappings)
Related Comparisons
Other ISO 9001:2015 comparisons
Other ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
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What are the key differences between ISO 9001:2015 and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
ISO 9001:2015 has 71 controls across its framework, while ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence covers 77 controls. Direct mapping analysis identifies 0 overlapping controls (1% coverage). The frameworks diverge most significantly in Operation, where 22 ISO 9001:2015 controls have no direct ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence equivalent.
How many controls map between ISO 9001:2015 and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
Of 71 total ISO 9001:2015 controls, 0 map directly to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls — representing 1% coverage. The remaining 56 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 9001:2015 to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
56 ISO 9001:2015 controls have no direct equivalent in ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. The highest concentration of gaps is in Operation with 22 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 9001:2015 and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
The domain with the highest gap count is Operation (22 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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