Frequently asked questions about ISO 15189
This page answers the questions that medical laboratories and their advisers ask most often about ISO 15189. ISO 15189 is the standard for the quality and competence of medical laboratories, and the RvA , the Dutch Accreditation Council, accredits laboratories against it. The answers below are short. For each question, we refer you to the page that covers it in detail.
Do you have a question that is not listed here? Start with what ISO 15189 is, or with the requirements per chapter.
Short answer: ISO 15189 is an accreditation standard for medical laboratories. It is not a certificate for the whole organisation. It is a recognition of the examinations that are in the scope.
What is the difference between ISO 15189 and ISO 17025?
ISO 15189 covers the whole process around the patient, from request to advice. ISO 17025 covers the technical competence of a test or calibration, regardless of who the client is. The chapter structure is the same in the 2022 version, but the requirements differ on points that relate to the patient. You can read the full difference on ISO 15189 vs ISO 17025.
Is ISO 15189 mandatory?
That depends on your situation. There is no general legal obligation to be accredited for every medical laboratory. For in-house tests in a healthcare institution, the European In Vitro Diagnostic Regulation (IVDR) does require the laboratory to comply with EN ISO 15189 or with national rules. Read the detailed explanation at is ISO 15189 mandatory?.
How long does ISO 15189 accreditation take?
On its page about the accreditation process , the RvA gives a timeline of six to twelve months. Your own preparation comes on top of that, and it is often the longest phase. See costs and timeline for a breakdown.
What does ISO 15189 accreditation cost?
We have not included the RvA rates on this page, because they can change. You should also budget for internal hours, equipment, proficiency testing and support. The structure of a budget is set out on costs and timeline.
Which version of the standard applies now?
The 2022 version. After 1 April 2023, the RvA no longer accepted new applications against the 2012 version. Since 31 December 2025, accreditations against that old version have lapsed. Read what changed at accreditation and the transition to 2022.
Can I download the standard for free?
No. ISO 15189 is a paid standard, and you buy the official text from the publisher. Read where you can get the standard legally for an explanation.
Do I have to take part in proficiency testing?
Yes, for accredited laboratories. On its page about medical laboratories , the RvA states that accredited laboratories must take part in proficiency testing schemes, in which the results of different laboratories are compared with each other. What you do with deviating results is part of your management system. See also the audit page, because the assessor often asks about this.
What is point-of-care testing under ISO 15189?
Point-of-care testing (POCT) is testing close to the patient, for example a glucose meter on a ward. Since the 2022 version, POCT falls under ISO 15189, and the separate standard ISO 22870 has been withdrawn. You arrange who is responsible for the POCT equipment within your own system. In ASR101, the RvA states that the additional requirements for POCT are included in EN-ISO 15189:2022. Read the explanation at POCT under ISO 15189.
Can a laboratory switch to ISO 17025?
It can, but it is not a simple choice. A medical laboratory that carries out patient testing and has results interpreted usually fits ISO 15189 better. Also consider the consequences for the IVDR. Discuss the choice with the RvA before you submit an application.
Does the accreditation cover all our sites?
Not automatically. An accreditation covers the sites and examinations that are in the scope. According to ASR101, the RvA does not list blood collection points on the scope, unless a laboratory is also located there. The RvA does check them through sampling. Check in advance which of your sites will be on the scope. The scope comes up again at every on-site assessment. See the audit page.
What is a flexible scope?
A flexible scope means that, within the accredited scope, the laboratory can add new or changed methods without notifying the RvA of every change. According to section 2.1 of the RvA accreditation specification ASR101 , a flexible scope applies if the laboratory meets the conditions in RvA-T054 (ASR004). The RvA sets up a source scope for each field together with the scientific associations. Read the conditions in RvA-T054 before you plan for it.
How do I check whether a laboratory is accredited?
You can search the RvA’s list of accredited organisations. That list shows which organisation is accredited and for which examinations. Always look at the scope and not only at the name. A laboratory may be accredited for some examinations and not for others.
What happens after accreditation?
After a positive decision, periodic assessments follow. The RvA then checks whether your system still works and whether the scope is still correct. In between, you maintain the management system, with internal audits, a management review and the handling of nonconformities. The requirements for this are on the requirements page.
What is the difference between a category A and a category B nonconformity?
The RvA does not use the terms major and minor. It classifies nonconformities as category A or category B. Category A is the most serious, for example incorrectly reported results, or missing quality controls that make it impossible to show that results are correct. The examples are given in annex C of the RvA accreditation specification ASR101 . For the difference between major and minor nonconformities in certification, read major and minor nonconformity.
How do I prepare best for the assessment?
Start with an internal audit and a document check of the last few months. Then choose a few recent samples that you can trace through the system, and make sure the related records are complete. The audit page describes what the assessors do during a day.
Is ISO 15189 more expensive than ISO 17025?
This cannot be stated as a single amount, and we have not been able to compare rates. The costs depend on the size of the scope and on how far you already are. So compare not the standards, but the scope and your own starting position. The structure of the costs is set out on costs and timeline.
How many people need to be involved in the process?
At least one quality officer, a laboratory manager and one or more specialists who know the subject matter. In practice, the process runs most smoothly when the analysts and the ward nurses also contribute. They know the work, and the assessor asks about them.
If you place all the preparation with one person, you take a big risk. That person becomes the bottleneck, and if they drop out, the project stops. Divide the tasks from the start.
Do I have to put the whole laboratory in the scope?
No. You can limit the accreditation to the examinations you master best. This is often a sensible choice, because you then only need to work out the requirements for a smaller set of examinations. You can extend the scope later.
Note that an examination outside the scope must not be presented as accredited. Use the accreditation mark on reports only for examinations that are in the scope. ASR101 gives misuse of the mark as an example of a category A nonconformity.
How long does an accreditation remain valid?
The RvA works with a four-year accreditation cycle. The cycle starts after the decision on an initial assessment or reassessment, and includes the surveillance assessments and the reassessment (ASR101, section 3.2). Ask the RvA how often surveillance assessments take place in your cycle. See also the RvA page on the accreditation process . Plan the assessments into your annual planning from the start.
What is the difference between an accreditation and a certificate?
A certificate confirms that an organisation meets a standard, and is often issued by a certification body. An accreditation confirms that a body is competent to carry out a particular type of work. For ISO 15189, this concerns the accreditation of the laboratory for certain examinations. Read the full difference at accreditation explained.