ISO 15189 accreditation and the transition to the 2022 version
ISO 15189 accreditation is the formal recognition by the Dutch Accreditation Council (Raad voor Accreditatie, RvA) that a medical laboratory works competently for the tests in its scope. Since 31 December 2025, accreditation is only granted against ISO 15189:2022 . The older 2012 version is no longer recognised internationally.
The transition is complete. According to the RvA , 203 accreditations were moved to the new version on time. If you apply for accreditation now, you apply directly against the 2022 version. You can read what it costs and how long it takes on costs and timeline. For the basics, start with what ISO 15189 is. To choose the right standard, read the difference from ISO 17025.
Short answer: the deadline for the transition to ISO 15189:2022 was 31 December 2025. Accreditations that had not been converted by then were withdrawn. New applications have only been accepted against the 2022 version since 1 April 2023.
Timeline of the transition to ISO 15189:2022
ILAC, the international cooperation of accreditation bodies, gave all countries a three-year transition period. The RvA worked this out in its own timeline. A summary is below, based on the RvA notice on the introduction .
| Date | What happened? |
|---|---|
| 6 December 2022 | ISO 15189:2022 published |
| 6 December 2022 to July 2023 | Preparation phase for laboratories and the RvA |
| 1 April 2023 | New applications only accepted against the 2022 version |
| 1 July 2023 | Voluntary transition phase: regular assessment against 2022 possible |
| November 2023 | Dutch translation NEN-EN-ISO 15189 available |
| 1 July 2024 | Mandatory transition phase: all regular assessments against 2022 |
| 6 October 2025 | Start of the withdrawal procedure if the assessment had not been completed positively |
| 31 December 2025 | Accreditations against the 2012 version expire |
What changed in ISO 15189:2022?
The new version is less prescriptive and more focused on risks to the patient. When training technical assessors, the RvA summarised it this way: laboratories can now set up their management system to suit their goals, with the needs of patients and users at the centre.
| Topic | ISO 15189:2012 | ISO 15189:2022 |
|---|---|---|
| Structure | Own structure with management and technical requirements | Same chapter structure as ISO/IEC 17025:2017 |
| Point-of-care testing (POCT) | Separate standard ISO 22870 | Included in ISO 15189; ISO 22870 is withdrawn |
| Risk management | Limited detail | Central, focused on risks to the patient |
| Impartiality | Less emphasis | Explicit requirements, as in ISO 17025 |
| Prescriptive procedures | Many mandatory procedures | More freedom in how you arrange things |
Because the structure is now the same as ISO 17025, organisations with both accreditations can align their systems more easily.
How an ISO 15189 accreditation works at the RvA
On its process page , the RvA gives a process of six to twelve months. Your own preparation comes on top of that.
Quick scan
Use the quick scan to check whether you are eligible. Medical tests fall under ISO 15189.
Application and documents
Submit your application with the required documents. This includes a list of the tests you want accredited.
Assessment
A lead assessor and technical assessors from the relevant field assess your laboratory on site. They look at both the system and the subject matter.
Resolving findings
You resolve non-conformities by analysing the cause and showing evidence that the measure works.
Decision and scope
After a positive decision, you receive an accreditation with a defined scope. Periodic assessments follow.
The RvA has a specific accreditation protocol for medical laboratories, SAP-M000. When it was revised for the 2022 version, the list of tests was aligned with the IGJ (Dutch Health and Youth Care Inspectorate) under the IVDR. This means laboratories do not have to supply the same information twice. You estimate the costs the same way as for ISO 17025 costs and lead time.
Example: patient-focused risk register for ISO 15189:2022
Risk management is the part that has grown most in the 2022 version. The fictional example below shows how a clinical chemistry laboratory records a few risks.
| Process step | Risk to the patient | Likelihood | Severity | Control measure | Owner |
|---|---|---|---|---|---|
| Sampling | Sample from the wrong patient | Low | High | Check two identifiers when taking the sample | Head of phlebotomy |
| Transport | Potassium result unreliable because transport takes too long | Medium | Medium | Maximum transport time, record on receipt | Reception team leader |
| Analysis | Undetected drift in an analyser | Low | High | Internal quality control with Westgard rules | Analyst |
| Reporting | Critical result does not reach the doctor in time | Low | High | Phone the ward and record who was called and when | Duty analyst |
| POCT | Glucose meter on the ward used by an untrained employee | Medium | Medium | Log in only with valid training | POCT coordinator |
You can also express likelihood and severity as numbers, as in a risk matrix. Update the register after incidents, complaints and deviating round-robin results. For a deeper analysis per process step, you can use an FMEA.
What does the RvA assessor want to see under ISO 15189:2022?
An assessor often follows a few samples through the whole process. Make sure you can show the following:
- An up-to-date risk register with control measures and owners, as above.
- Participation in round-robin tests and what you did with deviating results. The RvA records its policy for this in document T030 .
- How you safeguard impartiality, for example in commercial agreements with suppliers.
- How you control POCT outside the laboratory: training, checks and records. The POCT under ISO 15189 page describes this approach in more detail.
- How you apply the minimum standards from the NVKC (Dutch Society for Clinical Chemistry and Laboratory Medicine) sector guidelines.
Each of these topics has its own page. The requirements per chapter give an overview, and the audit page shows what the assessor does on site. Assessors often ask follow-up questions about critical results and traceability. For training and competence, they check the qualifications of your staff. For the sources of the standard itself, read how to obtain the standard legally.
Common mistakes in ISO 15189 accreditation
Risk management as a separate document. A register that nobody uses does not convince the assessor. Link it to your non-conformities and improvement actions, for example through a CAPA process.
Forgetting POCT. Glucose meters and blood gas analysers on the wards now fall under the same standard. Decide who is responsible for them.
Test list not up to date. A test that is not on the list is not covered by the accreditation. Check the list before the assessment starts.
Copying the old procedures word for word. The 2022 version requires fewer fixed procedures. Use that freedom to make your system simpler, not to keep everything as it is. For how to set up your manual for this, read the quality manual.
Frequently asked questions about the transition to ISO 15189:2022
Is the transition to ISO 15189:2022 still possible?
No, the transition is over. Since 31 December 2025, there is no accreditation left against the 2012 version. A laboratory without accreditation applies for a new accreditation against the 2022 version.
Does an accredited lab still need to do anything for the 2022 version now?
Not for the transition itself. The 2022 version is simply the standard against which you are assessed at every regular assessment. You follow up findings from the transition assessment like any other non-conformity.
What happened to ISO 22870 for point-of-care testing?
The requirements from ISO 22870 are included in ISO 15189:2022. According to the RvA, accredited POCT activities are now only assessed against ISO 15189:2022.