ISO 15189 PDF: where can you get the standard legally?

You buy the official text of ISO 15189 from the publisher. In the Netherlands, that is the Netherlands Standardisation Institute (NEN). It publishes the Dutch translation of the European version as NEN-EN-ISO 15189. A free PDF is usually not the official text, and it may be an outdated version. For accreditation, you need the current 2022 version.

To find out which version applies, read accreditation and the transition to 2022. The Dutch Accreditation Council (RvA) assesses against that version. The content of the requirements is explained on the requirements per chapter. For the main outline, start with what ISO 15189 is.

Which version do you need?

ISO 15189 exists in two main versions: the 2012 version and the 2022 version. The 2012 version has not been valid for accreditation since 31 December 2025. If you want accreditation now, you work with the 2022 version.

Check the title when you buy. There are ISO, EN and NEN editions. They often contain the same content, but it is important that you choose the right version and the right year. An edition from 2012 cannot be used for a new application.

On the ISO  website, you can find the title and scope of the standard. From there, you can go on to the publishers.

Which versions are often confused?

Search results often show several years and variants. It helps to recognise them before you buy.

The European version was designated as a harmonised standard for accreditation of medical laboratories in the Official Journal of the European Union on 20 February 2024. Amendment A11:2023 is included. This is set out in the implementing decision (EU) 2024/581 . The RvA refers to EN-ISO 15189:2022 in its specification ASR101. When you buy, check whether the amendment is in your edition.

What can you use?

You do not always need the standard to understand the content. Several sources explain it well without copying the standard itself.

The RvA explains medical laboratories on its own website. See the RvA page on medical laboratories  for the field and the obligations, and the RvA page on the accreditation process  for the procedure.

There are also professional groups. The NVKC  sets field standards with minimum requirements, and the RvA also assesses against these. These field standards are a good addition to the standard itself.

Why not a free PDF?

There are three reasons not to rely on a free PDF.

It is not the official text. A copy on the internet has not been checked. The RvA assesses your system against the official version, and a text that differs can lead to discussion.

It may be outdated. A PDF of the 2012 version looks like the new version, but the requirements have changed. With the old text, you build a system that no longer applies.

It is not allowed under copyright law. The standard is protected. Distributing or using an illegal copy is not acceptable, and at the very least it creates a problem if you copy the text into your manual.

How do you recognise a reliable source?

Not every site that offers a PDF is reliable. Look for a few signals before you download or copy anything.

• The title includes the year 2022, not just “ISO 15189” without a version.
• The source is a publisher or a government website, not a forum or an unknown download site.
• The text contains the recognisable chapter structure of the standard, with eight chapters.
• The text states the publisher, the copyright and the publication date.

If one signal is missing, buy the standard from the publisher. This costs money, but it prevents an assessment based on the wrong text. Ask the publisher for the current price, because it can change.

What if you already have an old version?

If you still have a copy of the 2012 version, you can keep it as a reference. Do not use it as the basis for your system any more. For a new application, or an assessment against the new requirements, you need the 2022 version.

A useful approach is to compare the two versions. Put the chapters side by side and note which requirements are new or worded differently. This comparison helps you with the transition and shows where your system still needs to change. Also read the transition to 2022 for the main changes.

Why the difference between the versions matters

The 2022 version is less prescriptive than the 2012 version, and it puts more emphasis on risks to the patient. This means your system must show which risks you have and how you control them. An old procedure that prescribes everything exactly does not automatically comply.

For the laboratory, this mainly means you need to think about your own risks. The requirements on the requirements page show how the chapters are structured, so you can determine which parts your system already covers.

How do you continue after purchase?

After purchase, read the standard and make a list of the requirements that apply to your laboratory. Then build the quality manual, as described on the quality manual.

Use the standard as a reference and write the implementation in your own words. An assessor wants to see that you understand the system, not that the standard has been copied word for word.

If you are unsure which standard fits, read ISO 15189 vs ISO 17025. A laboratory that does not work in patient care often needs a different standard.

Can I quote parts of the standard in my manual?

Short references to the standard are common, for example “in line with ISO 15189:2022, chapter 7”. Copying long passages word for word is different. That can be sensitive under copyright law, and it also makes your manual heavy and quick to go out of date.

A practical rule of thumb: refer to the standard, but describe in your own words what you do. An assessor then reads directly what happens in your department, not a copy of text they already know.

If you are not sure whether a passage may be copied, put the question to the publisher or to your legal adviser.

Further reading

• Accreditation and the transition to 2022
• Which requirements does ISO 15189 set?
• Frequently asked questions about ISO 15189
• What is ISO 15189?