Medical Laboratories — Requirements for Quality and Competence
ISO 15189:2022 is the accreditation standard for medical and clinical laboratories, specifying requirements for quality and competence. The fourth edition restructured the standard onto the ISO/IEC 17025 format, embedded a risk-based approach throughout, and brought point-of-care testing (POCT) into scope by absorbing the former ISO 22870. It sets general, structural, resource, process and management-system requirements across the total testing process — pre-examination, examination and post-examination. Accreditation bodies use it to accredit clinical laboratories, and it is distinct from ISO/IEC 17025, which covers testing and calibration laboratories generally. The standard centres on patient safety and the competence of the laboratory to deliver reliable results.
What this does not cover
stated in the document's own scope- It applies to medical/clinical laboratories, not general testing and calibration labs, which use ISO/IEC 17025.
- It is not a medical-device standard; device quality systems follow ISO 13485.
- It does not itself grant accreditation; that is the role of a national accreditation body operating a scheme.
- Good clinical laboratory practice for clinical-trial samples is a separate framework (WHO GCLP).
Always verify against the current published text before relying on it for a submission or inspection.
Overview
ISO 15189:2022 defines the requirements for quality and competence in medical laboratories, the standard against which clinical labs are accredited worldwide. It spans the total testing process — pre-examination, examination and post-examination — placing patient safety and reliable results at the centre. The fourth edition realigned the document to the ISO/IEC 17025 structure, wove a risk-based approach through every clause, and absorbed point-of-care testing from the withdrawn ISO 22870 so a lab runs one management system. It sets requirements for the laboratory's structure, resources, processes and management system, and is used by accreditation bodies as the basis for granting and maintaining accreditation.
Legal basis & how it acquires force
ISO 15189 is a voluntary consensus standard; its force comes from accreditation, not legislation. National accreditation bodies assess clinical laboratories against it, and in many health systems that accreditation is a condition of reimbursement, licensing or network participation, which makes conformity effectively mandatory in practice. The standard itself imposes no legal penalty; the accrediting body's scheme is the instrument that gives it teeth, and losing accreditation is the operative consequence.
Document structure
| Part | Covers |
|---|---|
| General requirements | Impartiality, confidentiality and patient welfare. |
| Structural and governance requirements | Organisation, responsibility and objectives. |
| Resource requirements | Personnel, facilities, equipment, reagents and externally provided services. |
| Process requirements | Pre-examination, examination and post-examination, including POCT. |
| Management-system requirements | Documents, records, audits, nonconformity and improvement. |
Key requirements
- Operate an impartial, competence-based management system covering the total testing process.
- Apply risk management to laboratory activities, addressing risks to patients and to result validity.
- Control pre-examination activities — request, collection, handling and transport of samples.
- Validate or verify examination procedures and ensure measurement traceability and quality control.
- Manage post-examination activities — result review, reporting, interpretation and retention.
- Ensure personnel competence, training and authorisation for each role, including point-of-care testing.
- Handle nonconformities, complaints and continual improvement, with internal audit and management review.
Implementation tips
- Map existing ISO 15189:2012 clauses onto the 2022 ISO/IEC 17025-style structure early so the transition is a re-mapping, not a rewrite.
- Fold point-of-care testing into the single management system rather than running the old ISO 22870 program in parallel.
- Tie quality-control and measurement-traceability records to each examination procedure so result validity is demonstrable.
International alignment
ISO 15189 is developed by ISO/TC 212 and, in its 2022 edition, adopts the structure and much of the terminology of ISO/IEC 17025, the general laboratory-competence standard. By absorbing the former ISO 22870 it now covers point-of-care testing within the same framework. Accreditation bodies affiliated with ILAC apply it internationally, supporting cross-border recognition of accredited clinical-laboratory results.
ISO 15189:2022: frequently asked questions
Quick answers to common questions about ISO 15189:2022.
What changed in ISO 15189:2022?
The fourth edition restructured the standard to the ISO/IEC 17025 format, embedded a risk-based approach, and brought point-of-care testing into scope by absorbing ISO 22870.
How is ISO 15189 different from ISO/IEC 17025?
ISO 15189 is specific to medical laboratories and the total testing process for patient care; ISO/IEC 17025 covers testing and calibration laboratories generally.
Does ISO 15189 now cover point-of-care testing?
Yes. The 2022 edition absorbed the former ISO 22870, so POCT is managed within the same accreditation.
Who accredits a laboratory to ISO 15189?
National accreditation bodies, typically operating under ILAC mutual-recognition arrangements, assess and grant accreditation.