ISO 14004:2016vsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
See exactly how ISO 14004:2016 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 14004:2016 maps to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence with 4% coverage across 2 directly mapped controls. Analysis of 48 ISO 14004:2016 controls identifies 46 compliance gaps — primarily concentrated in Support – ISO 14004:2016.
Source: TheArtOfService Knowledge Graph | 48 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.
Planning – ISO 14004:2016(1 mappings)
Operation – ISO 14004:2016(3 mappings)
Related Comparisons
Other ISO 14004:2016 comparisons
Other ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
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What are the key differences between ISO 14004:2016 and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
ISO 14004:2016 has 48 controls across its framework, while ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence covers 77 controls. Direct mapping analysis identifies 2 overlapping controls (4% coverage). The frameworks diverge most significantly in Support – ISO 14004:2016, where 11 ISO 14004:2016 controls have no direct ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence equivalent.
How many controls map between ISO 14004:2016 and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
Of 48 total ISO 14004:2016 controls, 2 map directly to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls — representing 4% coverage. The remaining 46 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 14004:2016 to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
46 ISO 14004:2016 controls have no direct equivalent in ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. The highest concentration of gaps is in Support – ISO 14004:2016 with 11 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 14004:2016 and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
The domain with the highest gap count is Support – ISO 14004:2016 (11 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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