Glossary · ISO and IEC standards for MedTech and pharma
ISO 15189
Also known as: ISO 15189:2022, EN ISO 15189, Medical laboratory accreditation standard
ISO 15189 is the international standard for quality and competence of medical laboratories. It sets requirements for impartiality, structure, resources, examination processes and the management system, and is the basis on which accreditation bodies accredit medical laboratories.
- Standards
- IVDR
In one sentence
ISO 15189:2022 sets quality and competence requirements for medical laboratories and is linked to the IVDR in-house device exemption.
Example
A university hospital laboratory accredited to ISO 15189 develops its own genetic test for a rare disease, documents why no CE-marked test meets the patient group's needs, and publishes the declaration required for in-house devices.
How it applies
- Legal hook: Under Article 5(5) IVDR, health institutions that manufacture and use in-house devices need an appropriate quality management system; for laboratories this means compliance with EN ISO 15189 or, where applicable, national provisions including those on accreditation.
- Scope: Pre-examination, examination and post-examination processes, including point-of-care testing, which the 2022 edition integrated.
- Risk management: The 2022 edition puts more weight on risk management and patient care; laboratories must identify and address risks to patients arising from their examinations.
- Competence evidence: Validation or verification of examination methods, measurement uncertainty, measurement traceability, calibration and participation in interlaboratory comparisons.
- Accreditation: National accreditation bodies assess laboratories against ISO 15189 for a defined scope of examinations. Accreditation covers that scope, not the laboratory as a whole.
- Technical documentation: Method validation records, the justification for in-house devices and the documentation required by Article 5(5) are distinct from the IVD manufacturer's technical documentation, but they have to be kept equally current.
ISO 15189 vs. ISO/IEC 17025
ISO/IEC 17025 applies to testing and calibration laboratories in general. ISO 15189 is specific to medical laboratories and adds requirements on patient samples, the clinical meaning of results, advisory services and patient safety. A medical laboratory is accredited to ISO 15189; a laboratory testing medical devices, for example for electrical safety, is accredited to ISO/IEC 17025.
Compared with the USA
In the USA, clinical laboratories are regulated under the Clinical Laboratory Improvement Amendments (CLIA, 42 CFR Part 493). ISO 15189 accreditation is voluntary there and doesn't replace CLIA certification.