Accreditation scheme · ISO 15189
Medical laboratories
Competence and quality requirements specific to medical laboratories, covering pre-examination, examination and post-examination processes for diagnostic testing.
Scope & benefits
What this scheme covers
Competence requirements, assessment workflow and surveillance rules for this scheme are maintained by the Assessment Team. Request the document pack for the normative details.
Mutual recognition
What accreditation under ISO 15189 provides
- Recognition of diagnostic competence for clinical decision-making.
- Alignment with EU health-sector requirements and professional practice.
- Mutual recognition through the EA-MLA and ILAC MRA for medical testing.
Assessment workflow
Application timeline
Every application follows the same documented sequence, from the initial document pack to the accreditation decision and surveillance cycle.
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Application
Application with clinical scope declaration and laboratory organisation chart.
Indicative duration: 10 business days
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Pre-assessment (optional)
Gap analysis visit against ISO 15189 requirements.
Indicative duration: 1 day
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On-site assessment
Assessment including examination of pre- and post-examination processes.
Indicative duration: 2–3 days
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Decision
Accreditation decision and publication in the register.
Indicative duration: 30 days
Document library
Mandatory documents
Forms and normative documents referenced by the assessment workflow. Always check the version before submission.
Application forms for this scheme are issued by the Assessment Team. Request the document pack through the application form.
Ready to begin?
Start your application
Applications are triaged by the Assessment Team. Acknowledgement is issued within 3 business days.