ISO 15189 vs ISO 17025
ISO 15189 is the accreditation standard for medical laboratories that test for patient care. ISO/IEC 17025 is the standard for testing and calibration laboratories in general. Both lead to accreditation by the Dutch Accreditation Council (RvA), but the RvA treats them as separate disciplines: medical laboratories and testing laboratories .
The main difference: ISO 15189 looks at the whole chain around the patient, from request and sample collection to the result and advice to the doctor. ISO 17025 looks at the technical competence for a test or calibration, regardless of who the client is. For the basics, start with what ISO 15189 is.
Rule of thumb: does your laboratory test patient material to help a doctor with diagnosis or treatment? Then ISO 15189 is the logical standard. Do you test or calibrate for industry, environment or trade? Then it is ISO 17025.
The differences between ISO 15189 and ISO 17025 at a glance
Since 2022, the two standards look more alike. ISO 15189:2022 follows the same chapter structure as ISO/IEC 17025:2017. The content differs on the points that relate to patient care.
| Topic | ISO 15189 | ISO/IEC 17025 |
|---|---|---|
| For whom? | Medical laboratories | Testing and calibration laboratories |
| Current version | ISO 15189:2022 | ISO/IEC 17025:2017 |
| Central focus | The patient and the requesting healthcare provider | The client and the reliability of the result |
| Process | Pre-analysis, analysis and post-analysis | Sampling (where applicable), test or calibration, reporting |
| Advice and interpretation | Part of the standard | Opinions and interpretations are possible, but not core |
| Point-of-care testing | Covered since 2022 | Not applicable |
| Risk approach | Focused on risks to the patient | Focused on risks to laboratory activities |
| Measurement uncertainty | Required where relevant to the result | Covered in detail, including decision rules |
| RvA discipline | Medical laboratories | Testing or calibration laboratories |
Pre-analysis is everything before the measurement: request, patient preparation, collection and transport. Post-analysis is everything after: review, reporting, interpretation and storage of samples. Those are the phases where most errors in healthcare tend to occur.
Examples: which standard fits which laboratory?
The examples below are fictional. They show how to reason about the choice. You make the final decision together with the RvA, for example through the quick scan .
| Laboratory | Work carried out | Logical standard |
|---|---|---|
| Hospital clinical chemistry lab | Blood tests for doctors, with advice on results | ISO 15189 |
| Independent GP laboratory | Sampling at blood collection points and analyses for GPs | ISO 15189 |
| Water laboratory | Testing drinking water and wastewater | ISO 17025 |
| Calibration company | Calibrating thermometers and pipettes, also for hospitals | ISO 17025 (calibration) |
| Food laboratory | Allergens and microbiology in food | ISO 17025 |
| Hospital with POCT | Blood glucose meters on wards under the laboratory’s supervision | ISO 15189 |
Not sure? Answer these three questions in order:
| Question | Yes | No |
|---|---|---|
| 1. Do you test material that comes from a patient? | Go to question 2 | ISO 17025 |
| 2. Does a healthcare provider use the result for diagnosis, treatment or prevention? | Go to question 3 | Discuss with the RvA |
| 3. Is interpretation or advice part of your service? | ISO 15189 | ISO 15189 is the likely fit, discuss ISO 17025 if needed |
Note the calibration company. It works for healthcare, but it does not test patient material. That is why ISO 17025 fits better. Reading the scope of an ISO 17025 accreditation works largely the same way as for ISO 15189, by the way.
Can a medical laboratory choose ISO 17025?
Sometimes. In early 2026, the RvA reported that some medical laboratories switched to ISO/IEC 17025 accreditation during the transition to the 2022 version. This mainly suits labs that do little direct patient care, or whose clients mainly ask for a technical test result.
When making that choice, also consider the consequences outside the accreditation. The European IVDR explicitly names EN ISO 15189 for in-house tests in healthcare institutions. To find out whether that obligation applies to your laboratory, read is ISO 15189 mandatory?. If you make your own tests for patient care, you therefore have a reason to stay with ISO 15189. Discuss this with the RvA. In the Netherlands, the Dutch Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd, IGJ) is the supervisory authority for the IVDR.
Is ISO 15189 a certificate or an accreditation?
It is an accreditation. ISO 15189 is meant to recognise the competence of medical laboratories, not to certify them as ISO 9001 does. The same applies to ISO 17025. Read the difference between the two forms of recognition at accreditation explained.
You can find answers to common questions about the standard itself on the FAQ about ISO 15189, and you can buy the standard as explained on download the standard.
A hospital can also hold ISO 9001 or a healthcare-specific quality mark for the rest of the organisation. That does not replace the laboratory accreditation. Also compare ISO 17025 with ISO 9001, because the same reasoning applies to ISO 15189.
What does the RvA assessor want to see when you apply for ISO 15189?
In an ISO 15189 assessment, the emphasis is on the chain around the patient. Prepare for questions such as:
- How do you ensure correct collection and identification of the patient and the sample?
- How do you review and report results, including critical values that must go straight to a doctor?
- Which risks to the patient have you mapped out, and what do you do about them?
- Do you take part in round-robin tests, and what do you do with deviating results?
- How do you control point-of-care testing outside the laboratory?
In an ISO 17025 assessment, the emphasis is different: method validation, measurement uncertainty and decision rules for a statement of conformity.
For how an ISO 15189 on-site assessment works, read the audit page. The requirements per chapter are on what does ISO 15189 require?.
Common mistakes when choosing between ISO 15189 and ISO 17025
Choosing based on the client instead of the activity. A lab that works for hospitals does not automatically do medical testing. Look at what you measure and what the result is used for.
Thinking the standards are interchangeable. The chapter structure is the same, but an ISO 17025 accreditation does not cover interpretation and advice to doctors. For what that means for your manual, read the quality manual.
Forgetting the IVDR. If you make your own tests for patients, more applies to you than the accreditation standard alone.
Frequently asked questions about ISO 15189 and ISO 17025
Can one organisation hold both accreditations?
Yes. A hospital can, for example, have a medical laboratory with ISO 15189 and a medical physics department that calibrates equipment under ISO 17025. Each accreditation then has its own scope. Because the chapter structure is the same, you can share many procedures.
Is ISO 15189 stricter than ISO 17025?
Not stricter, but broader. ISO 15189 adds requirements around the patient, such as collection, interpretation and advice. ISO 17025 goes deeper into topics such as decision rules for statements of conformity. Which standard feels heavier depends on your work.
Which standard applies to point-of-care testing?
ISO 15189:2022. The separate POCT standard ISO 22870 has been included in the 2022 version. You can read more about the practice on POCT under ISO 15189, and about the change in the transition to ISO 15189:2022.