ISO 15189 audit: how does the on-site assessment work?
An ISO 15189 audit is the assessment in which the Dutch Accreditation Council (RvA) checks whether your laboratory meets the standard. A lead assessor and technical assessors come on site, follow samples through the process and ask staff questions. The aim is to confirm that your tests are reliable for the patient.
This assessment is part of the wider accreditation process, which takes six to twelve months according to the RvA. If you want to read the requirements first, start with the requirements per chapter. An audit is not the same as an internal audit. You carry out the internal audit yourself, while an external party carries out the RvA assessment.
Short answer: the assessors follow a handful of samples from start to finish. They check whether the procedures work, not only whether they exist. Prepare by showing, for each sample, who received it, what happened and what result came out.
Who comes to visit?
An ISO 15189 assessment usually involves two types of assessor. The lead assessor looks at the management system: documents, responsibilities and how everything fits together. Technical assessors come from the field itself, for example clinical chemistry or microbiology. They look at the subject matter of your tests.
This combination is typical for medical laboratories. According to the RvA accreditation specification ASR101 , the RvA assesses at least one test from each part of the scope within a four-year accreditation cycle. For blood collection points and POCT locations, it takes a sample of the locations. A system that looks right on paper can still fail if the analyst carries out the method differently from how it is described.
What does an assessment day look like?
The exact schedule differs per laboratory. The following is a common pattern, worked out as an example.
Opening meeting
The assessors go through the scope: which tests, at which locations and with which equipment. Make sure the list of tests is correct. A test that is not on the list is not covered by the accreditation.
Following samples
The assessors choose a few samples and follow them from request to result. They ask where the sample was, who received it and how it was stored. This is the heart of the audit.
Equipment and methods
They look at a chosen analyser: calibration, quality controls, maintenance and logbooks. Method validation also comes up here.
Conversations with staff
Staff answer questions about their work, their training and how they handle deviations. The assessor wants to hear that the process is known to everyone, not only to the quality officer.
Closing meeting and findings
At the end, the assessors discuss their findings. You then resolve non-conformities by analysing the cause and showing evidence that the measure works.
What do the assessors ask?
An assessor almost always asks the same kind of questions, whatever the test. They want to know how it works, who does it and how you monitor it.
| Topic | Typical question | What you show |
|---|---|---|
| Identification | How do you know this sample belongs to this patient? | The identification process at collection and receipt |
| Critical results | What happens when a result is critical? | A procedure with a record of who, when and to whom |
| Equipment | When was this device last calibrated? | The calibration register and logbooks |
| Round-robin testing | How did the last round go? | Results and what you did with deviating results |
| Non-conformities | Which non-conformities did you have last year? | A log with cause and measure |
| Staff | How do you know this employee is competent? | The competence matrix and training records |
Also read the pages on staff competence and critical results. These two topics almost always come up.
Common mistakes during the audit
Reading out procedures instead of showing them. An assessor asks for evidence. Show the record for the sample they have just followed, not only the text of the procedure.
Knowing the system but not the work. If the quality officer knows everything and the analyst does not, that is a finding. Let staff explain in their own words how they do the work.
Running tests outside the scope. A test that is carried out but is not on the scope list leads to a finding. If you use the accreditation mark for an activity that is not accredited, ASR101 gives that as an example of a category A non-conformity, the most serious category. Check the list before the assessment starts.
Presenting the risk register as a separate document. The assessor wants to see that the risks lead to measures and that those measures work. Link the register to non-conformities and improvement actions.
What happens to the findings?
An assessment usually produces findings. These differ in severity. The RvA speaks of category A and B non-conformities, not major and minor. Category A is the most serious. ASR101 gives these examples of a category A non-conformity: incorrect results reported, no demonstrably correct results because quality controls are missing, or so many missing records that it cannot be checked whether tests were carried out correctly. The full list is in Annex C of ASR101 . How the RvA includes a non-conformity in the decision varies case by case.
You respond with an analysis of the cause and a plan of action. The assessor then checks whether the measure works. That can be a follow-up visit or a check of the documents.
This page does not give a fixed list of deadlines, because the RvA sets them for each assessment. Ask your assessor for the current agreements. The policy for non-conformities is set out in RvA policy rule BR004 (beleidsregel BR004), a 2021 version. Check whether a newer one exists.
How do you prepare for an audit?
Start well before the date. An internal audit beforehand shows where things still need work. To do this, go through the internal audit and note which findings you can already see yourself.
Make sure the files for the last few months are complete. Missing older records are harder to explain than a mistake you found and fixed yourself.
Make a list of the samples you can show. Preferably choose ordinary, recent samples, not the most unusual cases. An assessor wants to see everyday practice.
What if you disagree with a finding?
A finding is the start of a conversation, not a final verdict. If you have facts the assessor did not have, bring them in. Do this calmly and with evidence.
Prepare a short explanation for each finding: what happened, which record proves it and why you believe the system works. If the assessor sees it differently, ask what exactly is missing. Often it is a missing step in the evidence, not the whole process.
You resolve a finding you accept with an analysis of the cause. You support a finding you disagree with using facts.
What happens after the assessment?
After the assessment, you receive a report with the findings. Read it carefully and note a responsible person and a deadline for each finding. This is the basis for your plan of action.
Then you get to work. The assessor checks the solution later, as described above. In the meantime the system stays in use, which means you must keep doing your work properly. A laboratory that slips back after the assessment has more work to do than one that keeps developing its system.
See also the CAPA process for how you resolve a finding in a structural way, and the management review to discuss the outcomes with the board.
Common mistakes when preparing
Starting only after the application. Then the assessment is almost scheduled and there is little time left. Begin preparing well before you submit the application.
Letting only the quality officer speak. The assessor wants to hear from the analysts and nurses that the work is right. Practise with the whole team.
Presenting a perfect picture. An assessor does not believe a system without errors. Show how you find and resolve errors. That is the evidence that the system is alive.