ISO 15189 is the international standard that sets requirements for quality and competence in medical laboratories, and it is the standard accreditation bodies use to accredit them. The current edition is ISO 15189:2022, published in December 2022, and the transition from the 2012 edition ended in December 2025.
This guide is for laboratory directors and quality managers in hospital, private and reference laboratories.
Which edition of ISO 15189 is current, and what changed in 2022?
ISO 15189:2022 is the fourth edition. ISO's page for the standard shows it replaced both ISO 15189:2012 and ISO 22870:2016, the old point-of-care testing (POCT) standard. It was prepared by ISO/TC 212 and runs to 62 pages.
The foreword lists three main changes. The layout now follows ISO/IEC 17025:2017, so the management system requirements moved to the end. The POCT requirements from ISO 22870 were brought in. Risk management gained more weight.
The 2022 edition also aligns its risk management with ISO 22367, laboratory safety with ISO 15190 and sample collection and transport with ISO 20658. Annex C compares it with the 2012 edition, clause by clause, which helps when you update an older system.
Is a 2012 accreditation still valid?
Not under the international arrangement. ILAC Resolution GA 26.08 gave accredited laboratories three years from publication to move to the 2022 edition. ILAC set that deadline as December 2025.
After the deadline, accreditation to ISO 15189:2012 is no longer recognised under the ILAC arrangement. The same applies to POCT accredited to ISO 22870:2016 together with the 2012 edition.
Since 1 January 2026, the international arrangement has been run by Global Accreditation Cooperation Incorporated (Global ACI), formerly ILAC and IAF. Its recognition arrangement lists ISO 15189 as a testing scope, and accreditations recognised under the ILAC arrangement continue to be recognised during the move. If your certificate or your referral laboratory's certificate still cites 2012, ask the accreditation body for its status.
What does ISO 15189:2022 require, clause by clause?
The requirements sit in clauses 4 to 8, with a normative Annex A for POCT. The table shows each group and the records assessors usually trace. The records column is AGS's interpretation, not the standard's wording.
| Clause | What it covers | Records assessors usually ask for |
|---|---|---|
| 4 | Impartiality, confidentiality, requirements regarding patients | Impartiality risk review, confidentiality agreements, patient information |
| 5 | Legal entity, laboratory director, laboratory activities and advisory services, structure, objectives, risk management | Licence, director's competence and delegations, scope of examinations, risk register |
| 6.2 to 6.6 | Personnel, facilities, equipment, calibration and traceability, reagents and consumables | Competence and authorisation records, temperature logs, calibration records, reagent lot acceptance |
| 6.7 and 6.8 | Agreements with users and POCT operators, external providers, referral laboratories and consultants | Service agreements, approved supplier list, referral laboratory register |
| 7.2 | Pre-examination: requests, sample collection, transport and receipt | Collection manual, transport conditions, sample rejection log |
| 7.3 | Examination: method verification and validation, measurement uncertainty, reference intervals, validity of results | Verification reports, uncertainty estimates, IQC review logs, EQA results |
| 7.4 to 7.8 | Reporting, sample retention, nonconforming work, information systems, complaints, continuity and emergency planning | Critical result log, LIS validation and downtime plan, complaint log, emergency plan |
| 8 | Management system: documents, records, risks, improvement, corrective action, quality indicators, internal audit, management review | Quality indicator data, audit reports, corrective actions, review minutes |
The standard also notes that it can be applied to other healthcare services, such as diagnostic imaging, respiratory therapy, blood banks and transfusion services.
What do Gulf accreditation bodies ask for at application?
In the UAE, the Emirates International Accreditation Centre (EIAC) accredits medical laboratories to ISO 15189 in areas such as clinical biochemistry, haematology, microbiology and pathology. It published its own circular on the transition to the 2022 edition in July 2023.
EIAC's application list shows what a laboratory must already have running before it applies. For medical laboratories it asks for six months of consolidated proficiency testing, interlaboratory comparison and IQC results. It also asks for the last management review minutes and the last internal audit report.
Two items catch laboratories out. EIAC asks for evidence of a medical advisory or multidisciplinary committee for POCT. It also asks for a mobile laboratory sample collection manual.
Laboratories in a hospital may also face JCI, which offers a laboratory programme based on ISO 15189:2022 alongside its own standards. Our guide to JCI laboratory accreditation compares the two routes. Saudi readers can start with our guide to CBAHI standards for clinical laboratories and blood banks.
What will assessors check at the bench?
Assessors test whether practice matches the documents. The points below are AGS's practical reading of the 2022 clauses, not the standard's text.
- A traced sample: request, patient identification, collection, transport conditions, receipt, analysis under QC, review and report.
- Reference intervals: evidence that the intervals you report suit the population you serve, not only the reagent insert.
- Referral work: a register of referral laboratories, how you chose them, and their accreditation status.
- Information systems: LIS validation, user access, and a downtime plan that staff can describe.
- POCT: a list of devices and sites, trained and authorised operators, and QC records from the ward, not only the laboratory.
External quality assessment is one of the most traced records. Our guide to ISO/IEC 17043:2023 explains how proficiency testing schemes are run and how to judge a provider.
How is ISO 15189 different from ISO/IEC 17025?
Both share the same layout, but they serve different laboratories. ISO 15189 is written for medical laboratories that examine samples from patients, and it adds the patient, the laboratory director, clinical advice, critical results and POCT. ISO/IEC 17025 covers testing and calibration laboratories in general.
A clinical laboratory is accredited to ISO 15189. A food, water or calibration laboratory is accredited to ISO/IEC 17025, which our ISO/IEC 17025 guide covers.
How AGS can help
The ISO 15189 Management System kit contains 79 editable Microsoft Word documents. It includes a quality manual, 25 procedures from sample collection to POCT, and 30 forms, such as method verification, IQC review, EQA and critical result logs. It also has 12 checklists, including an ISO 15189:2022 internal audit checklist and an accreditation gap analysis, 5 guidance documents and 3 training files.
Frequently asked questions
Does ISO 15189 require a specific LIS or sample tracking system?
No. The standard does not name any product. Clause 7.6 sets requirements for managing data and information systems, including plans for downtime.
Can a laboratory be accredited for only some of its examinations?
Yes. Accreditation covers the examinations listed in the scope, such as a histopathology or microbiology menu. A laboratory can apply to extend the scope later.
Is ISO 15189 certification the same as accreditation?
No. Medical laboratories are accredited to ISO 15189 by an accreditation body, which assesses technical competence. Certification to a management system standard such as ISO 9001 does not cover that competence.
Does buying documentation mean the laboratory will be accredited?
No. Documents are a starting point. Accreditation depends on how the system is implemented and on the accreditation body's assessment.
AGS provides independent documentation toolkits. This guide and the referenced kit are not affiliated with, endorsed by or approved by ISO, ILAC, Global ACI, EIAC, Joint Commission International, CBAHI or any other accreditation body. They do not guarantee any assessment or accreditation outcome.
Reviewed October 2026. Facts checked against the sources current at publication.
