Definition · Plain-language
ISO 15189
ISO 15189 is the international standard for quality and competence in medical (clinical) laboratories, used as the basis for accrediting diagnostic labs.
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A standard for clinical laboratories
ISO 15189 is written specifically for medical laboratories — those examining materials derived from the human body to provide information for diagnosis, monitoring and treatment. It recognises that clinical testing is part of patient care, so it addresses the entire pathway: pre-examination steps such as test requesting, patient preparation and sample collection; the examination itself; and post-examination steps including result reporting and clinical interpretation. Because errors anywhere in this chain can affect patient outcomes, the standard places strong emphasis on competence, quality control and managing the interface between the laboratory and clinicians.
Quality and competence requirements
ISO 15189:2022 combines management-system requirements with technical and competence requirements similar in spirit to ISO/IEC 17025, from which it draws. It addresses personnel competence and authorisation, equipment and reagents, validation and verification of examination methods, measurement traceability and uncertainty where relevant, internal quality control, external quality assessment (proficiency testing), and the reporting of results. The 2022 revision strengthened the focus on risk management and on patient safety, and aligned the standard more closely with ISO/IEC 17025 in structure while keeping its distinct clinical scope.
Accreditation and patient assurance
Medical laboratories are accredited to ISO 15189 by national accreditation bodies that assess both quality management and technical competence. Accreditation provides clinicians, patients, regulators and payers with confidence that diagnostic results are reliable and the laboratory operates competently. In many health systems ISO 15189 accreditation is expected or required for clinical laboratories, and it is internationally recognised through the same accreditation cooperation arrangements that support other laboratory accreditation. It complements, and in some jurisdictions sits alongside, statutory schemes such as the US CLIA programme.
Key facts
At a glance
- Definition: requirements for quality and competence in medical laboratories
- Current version: ISO 15189:2022
- Scope: clinical (diagnostic) laboratories and the full testing pathway
- Covers: pre-examination, examination and post-examination phases
- Used for: accreditation of medical laboratories
- Relationship: derived from and aligned with ISO/IEC 17025
Common misconceptions
What people often get wrong
Often heard: ISO 15189 and ISO/IEC 17025 are interchangeable for any laboratory.
Actually: They overlap but differ in scope. ISO/IEC 17025 covers testing and calibration laboratories generally; ISO 15189 is specific to medical laboratories and addresses clinical concerns such as patient preparation, sample handling and result interpretation that ISO/IEC 17025 does not.
Often heard: Medical laboratories are certified to ISO 15189.
Actually: Medical laboratories are accredited to ISO 15189, not certified. Accreditation formally recognises the laboratory’s technical competence as well as its quality management, which is more than certification of a management system.
Often heard: ISO 15189 accreditation replaces national clinical-testing regulation.
Actually: ISO 15189 provides internationally recognised assurance of quality and competence, but it does not replace statutory schemes. In the United States, for example, clinical laboratories must also meet CLIA requirements; ISO 15189 can complement but not substitute for such law.
Going deeper
