ISO 15189 Accreditation: Requirements for Medical Laboratories

What ISO 15189 Requires

ISO 15189 is the international standard for quality and competence in medical laboratories. It covers both management system requirements and the technical competence requirements specific to laboratory testing. Accreditation is granted by recognized accreditation bodies — in the United States, these include ANAB, A2LA, and the CAP 15189 program.

CLIA Disclosure

ISO 15189 accreditation is not recognized by the FDA as equivalent to CLIA certification under 42 CFR Part 493. US laboratories must maintain CLIA certification independently. ISO 15189 accreditation addresses laboratory quality management and competence — it does not satisfy federal CLIA requirements.

Key Compliance Areas

• Document control
• Competency assessment of laboratory personnel
• Equipment qualification and calibration
• Method validation
• Measurement uncertainty
• Pre-examination and post-examination processes
• Quality indicators
• External quality assessment (proficiency testing)
• Internal audit
• Management review

US Accreditation Pathways

Three primary pathways operate in the United States: ANAB (the ANSI National Accreditation Board), A2LA (the American Association for Laboratory Accreditation), and the CAP 15189 program. Each has its own application and assessment process, and costs and timelines vary by body and by laboratory scope.

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