What is ISO 15189?
ISO 15189 is the international standard with requirements for the quality and competence of medical laboratories. A laboratory uses it to show that it carries out reliable testing on blood, urine, tissue and other patient material, from request to result and advice. The current version is ISO 15189:2022 , available in the Netherlands as NEN-EN-ISO 15189.
In the Netherlands, the Dutch Accreditation Council (RvA) accredits medical laboratories based on ISO 15189. This is an accreditation for defined tests, not a certificate for the whole organisation. For testing and calibration laboratories outside patient care, ISO 17025 is the right standard. You can read the difference on ISO 15189 vs ISO 17025.
In short: ISO 15189 covers the whole laboratory process around the patient, including sample collection, interpretation and advice to the doctor. Since 31 December 2025, all RvA accreditations are based on the 2022 version.
ISO 15189 in brief
| Question | Answer |
|---|---|
| For whom? | Medical laboratories: clinical chemistry, microbiology, pathology, genetics and more |
| Current version | ISO 15189:2022, published on 6 December 2022 |
| Who accredits in the Netherlands? | The Dutch Accreditation Council (Raad voor Accreditatie, RvA) |
| What is recognised? | The tests and locations in the scope of accreditation |
| Point-of-care testing? | Included in ISO 15189 since the 2022 version; ISO 22870 is withdrawn |
| Round-robin testing | Mandatory for accredited laboratories |
| Old version | ISO 15189:2012 has not been recognised since 31 December 2025 |
Who uses ISO 15189?
Mainly hospital laboratories, but also independent medical laboratories and anticoagulation services. According to the RvA, medical laboratories employ specialists who interpret results and advise the person who requested the test. That advisory part is what makes ISO 15189 different from a standard for measurement alone.
The professional field plays a major role. The NVKC (Dutch Society for Clinical Chemistry and Laboratory Medicine) sets sector guidelines with minimum standards, which the RvA also checks. The external quality assessment with round-robin tests is organised, among others, by the SKML .
Example: a GP requests an HbA1c test for a patient with diabetes. The laboratory must control the collection, the transport, the measurement, the result and any advice. ISO 15189 looks at that whole chain, not only at the device.
Where does ISO 15189 come from in the Netherlands?
Until 2019, Dutch medical laboratories were accredited under the CCKL practice guideline. CCKL became part of the RvA in 2008. On 1 July 2019, the move to ISO 15189 was complete, with 239 accredited medical laboratories at that time.
Everything about ISO 15189
Choose the page that fits your question. A laboratory manager usually starts with accreditation. A buyer or quality officer starts with the difference from ISO 17025. If you want to know what it costs, read costs and timeline. If you want to know whether the standard is mandatory, read is ISO 15189 mandatory?.
Which standard fits which laboratory.
ISO 15189 vs ISO 17025The accreditation process and what the 2022 version changed.
Accreditation and the 2022 transitionWhat accreditation costs and how long the process takes.
Costs and timelineThe requirements per chapter, from general requirements to the management system.
Which requirements does ISO 15189 set?How the assessment works and what the assessor wants to see.
On-site auditShort answers to the questions laboratories ask most often.
Frequently asked questionsWhen the standard applies by law or by contract, and when it does not.
Is ISO 15189 mandatory?What belongs in it and how to structure procedures and records.
Quality manualThe procedure for getting critical results to the doctor.
Critical resultsWho is responsible for glucose meters and other meters on wards.
POCT under ISO 15189How to demonstrate the competence of staff.
Training and competenceMetrological traceability of measurement results, explained.
TraceabilityWhere to buy the standard legally and which version applies.
Download the standardThe standard for testing and calibration laboratories.
ISO 17025 for laboratoriesThe difference between accreditation and certification.
Accreditation explainedISO 15189 and the IVDR
The European regulation on in vitro diagnostics (IVDR, Regulation (EU) 2017/746 ) mentions ISO 15189 by name. If a healthcare institution makes its own tests for internal use, the laboratory must, among other things, meet EN ISO 15189 or national provisions. This is set out in Article 5(5). ISO 15189 alone is not enough in that case: the IVDR also sets requirements for design, documentation and a public declaration.
Sources
- RvA: medical laboratories
- RvA: medical laboratories accredited against ISO 15189:2022
- ISO: ISO 15189:2022
- NVKC: quality and guidelines