Is ISO 15189 mandatory?
ISO 15189 is not generally a legal requirement for every medical laboratory. An accredited laboratory must, however, comply with the standard and take part in proficiency testing. For in-house tests that a healthcare institution carries out itself, the European In Vitro Diagnostic Regulation (IVDR) refers to ISO 15189. What applies to your laboratory depends on whether you hold accreditation, which tests you carry out and whether you make your own tests.
This outcome is built up from three sources: the RvA on medical laboratories , the IVDR, Regulation (EU) 2017/746 and the RvA accreditation process . For the difference between accreditation and certification, see accreditation explained.
This is an indication, not legal advice. The legal position of your laboratory depends on your role, your tests and your care provider. If you are unsure, have the question assessed by the RvA or by an adviser who knows the legislation.
What does the RvA say?
The RvA accredits medical laboratories on the basis of ISO 15189. On its page about medical laboratories, it states that accredited laboratories must take part in proficiency testing. On that page, the RvA does not cite a legal basis for this obligation. The duty comes with the accreditation.
This distinction matters. If you do not hold accreditation, the RvA’s proficiency testing obligation does not apply to you. However, if you are accredited, you must follow the RvA’s rules, and that means proficiency testing.
What does the IVDR say?
The IVDR (Regulation (EU) 2017/746) governs in vitro diagnostics. For tests that a healthcare institution develops itself and uses for its own patients, known as in-house tests, the regulation refers to ISO 15189. The provision that regulates this is Article 5, paragraph 5, point (c). It states that the laboratory of the healthcare institution must comply with EN ISO 15189 or, where applicable, with national provisions, including those on accreditation. Point (b) states that the test must be made and used under a suitable quality management system.
ISO 15189 alone is not enough for this. The standard does not cover the design of a device, so your quality system must also cover design and production. The regulation also requires documentation and a public declaration. Whether you must be accredited depends on national provisions. Read the article yourself or have it assessed.
When is it effectively mandatory?
In practice, the standard often counts as a requirement, even where the law does not say so explicitly. Consider the following:
| Situation | What applies? |
|---|---|
| Hospital lab with RvA accreditation | Requirements of the standard and proficiency testing, mandatory through the accreditation |
| Independent medical lab without accreditation | No general obligation found, but clients often expect it |
| Healthcare institution with its own in-house tests | The IVDR requires the lab to comply with EN ISO 15189 or national provisions |
| Lab working in care under a contract | Contractual requirements from the client can call for the standard |
The last row is common. A health insurer or a hospital may ask for accreditation in a procurement agreement. Check your contracts, because they can be more binding than the standard itself.
What does this mean for your laboratory?
Start with three questions. Do you already have accreditation? Do you make your own tests? Does a client ask for the standard? Those answers show whether it is mandatory in your case.
If you have no accreditation but do make your own tests, it is sensible to have your IVDR position checked. The transition to ISO 15189:2022 shows how the standard has changed, and the comparison with ISO 17025 helps you choose which standard fits.
A realistic timeline belongs with the costs of any application. You can find one on costs and timeline.
A short self-check
Go through these questions with your director or your quality officer. They are intended to help you ask the right question, not to give a legal judgment.
- Do we examine material from a patient, and does a doctor use the result for care?
- Do we hold RvA accreditation, or are we applying for it?
- Do we make our own tests that we develop ourselves and use for patients?
- Does a contract with a client or health insurer include a requirement on accreditation or the standard?
- Do we have an adviser or a lawyer who knows the IVDR and the legislation for laboratories?
If you answer yes to question 1 or 3, ISO 15189 belongs on your agenda. If you answer yes to question 4, read the contract again, because that is where the requirement you must meet is set out. If you answer no to all the questions, the standard is probably not mandatory for you, but voluntary accreditation may still have value.
Why the obligation is often unclear
The obligation is spread across several sources: the European regulation, the RvA rules and the requirements of clients. None of these sources gives the answer for every laboratory in a single sentence. As a result, many labs think they do not need to do anything, while their own contracts or tests contain a requirement.
As a consequence, the question often only comes up during a tender or a new contract. By then there is little time left. So check your position in advance, so that you do not face a deadline you were unaware of.
What does it cost not to comply?
The answer depends on your situation. For an accreditation you already hold, failing to meet the standard or the proficiency testing obligation can lead to findings and, eventually, to loss of accreditation for the examinations concerned. That is a business risk, not only a formal problem.
For a laboratory without accreditation, the risk is mainly commercial. If a client asks for the standard in the tender, you can be excluded without accreditation, even if your quality is good.
For in-house tests in a healthcare institution, the risk is of a different order. A test that does not meet the IVDR requirements does not fit within the legal framework for in vitro diagnostics. Discuss this with the supervisory body, the Inspectie Gezondheidszorg en Jeugd (Health and Youth Care Inspectorate, IGJ), or with a lawyer who knows the regulations.
How does this fit with the rest of the section?
If you decide to follow the standard, start with the requirements per chapter on the requirements page. After that comes the preparation and the manual. See the quality manual for how that document is structured.
If you are torn between two standards, the comparison on ISO 15189 vs ISO 17025 helps. If you are looking at costs, costs and timeline gives a breakdown that is also useful for a mandatory application.
What if you still cannot decide?
Then the question is too big to answer on your own. Start by recording the facts: which tests you carry out, which contracts you have, and which accreditation or licence you hold. With that overview, you can ask for targeted advice.
Ask the RvA for advice on the accreditation question, the Inspectie Gezondheidszorg en Jeugd (Health and Youth Care Inspectorate) for the supervisory question, and a lawyer for the contractual side. These three questions differ, and no single party answers all of them.
Common misunderstandings
Mandatory means certified. No. ISO 15189 is accredited, not certified. You can read the difference at accreditation explained.
Your own quality manual is enough. For in-house tests, the IVDR expects a suitable quality system and a laboratory that complies with EN ISO 15189 or national provisions. A manual alone is not enough.
If you are not accredited, you need do nothing. That is not correct. Without accreditation, the law and your client’s requirements still apply.