ISO 15189 training and competence: how do you demonstrate proficiency?
Under ISO 15189, you must show that every member of staff who carries out an examination or reviews results is competent to do so. Training is one piece of evidence, but it is not enough. The assessor wants to see that the staff member also masters the task, and that you monitor this over time. That is the difference between completing a course and being competent.
The requirements for personnel belong to the resources in the standard. See the requirements per chapter. During the on-site assessment, a technical assessor often checks this evidence. To start with the wider context, begin with what ISO 15189 is.
Short answer: a competent person carries out a task independently and correctly, and can keep doing so demonstrably. Record which tasks belong to each role, and monitor for each staff member whether they still master them.
Training or competence?
Training is what someone has done. Competence is what someone can do. The first appears on a certificate, the second shows in the work. An assessor looks at the second.
An example: an analyst has passed a pipetting course. That is training. But whether that analyst pipettes a sample correctly only becomes clear when you watch them do it and check the results of their work.
The standard builds in this double check. You must show training, experience and authorisation together.
What do you record for each role?
Start with the roles. For each role, describe which tasks belong to it and which evidence you expect. That prevents discussion afterwards.
| Role | Tasks | Required training | Evidence of competence |
|---|---|---|---|
| Clinical chemistry analyst | Sample processing, analyser operation, quality control | Professional training and internal instruction | Observation, checked results |
| Nurse (POCT) | Measurement with a glucose meter, recording | POCT instruction | Passed test, statement of authorisation |
| Sample collector | Collection, identification, labelling | Instruction on collection and identification | Observation, errors in records |
| Medical specialist | Interpretation of results, advice | Specialist training | Confirmation of authorisation by the organisation |
This table is a tool. Fill in the columns for your own roles, and make sure the training requirements match the reality in your department.
Example: a competence matrix for one analyst
A competence matrix shows which tasks each staff member has mastered. Below is a fictional example for one analyst.
| Task | Trained on | Assessed on | Status | Next check |
|---|---|---|---|---|
| Prepare samples | 12 March | 2 June | Authorised | June next year |
| Operate analyser A | 20 April | 15 July | Authorised | July next year |
| Operate analyser B | 1 September | Not yet | In training | Not yet applicable |
| Report a critical result | 10 May | 5 August | Authorised | August next year |
The status follows from the assessment, not from the training. A staff member who is still in training may only carry out the task under supervision. Record that too.
How do you assess competence?
An assessment is an observation of the work, supplemented by a check of the results. This can be a fixed routine.
Decide what is being assessed
Take the task from the matrix. Describe what doing it correctly means, using a short checklist.
Observe
An experienced colleague or coordinator watches while the staff member carries out the task. Note what went well and what could be better.
Check the results
Look at the outcomes of the staff member’s work, for example proficiency testing or a check of the quality records.
Confirm authorisation
An authorised manager decides whether the staff member is competent. Record that decision with the date and a signature.
Repeat
Set a fixed repeat, for example once a year or after a change in method or device. Enter that date in the matrix.
What does the assessor ask for?
An assessor often chooses a staff member from the duty roster and asks for their file. They want to see the training, the assessment and the repeat at a glance.
They also want to know whether the staff member can explain the task in practice. Ask an analyst to describe the whole process for one sample. This shows whether the training has stuck.
They also check whether the matrix is up to date. A staff member who has left, or a task that no longer exists, should no longer appear in the matrix.
Common mistakes
Training treated as authorisation. A certificate does not show that someone masters the work. Always put an assessment alongside it.
No repeat. An assessment that was done once and never repeated is out of date after a year. Set a fixed period.
A matrix that does not match the work. If the matrix contains tasks that nobody performs, or misses tasks that do happen, it is unreliable.
Temporary staff left out. Agency staff and trainees must also demonstrably be competent for the tasks they carry out.
How do you start?
Make a list of all the roles in the laboratory. Note the tasks for each role. Then make a matrix for each staff member and schedule the first assessments.
Also read the quality manual for where the competence requirements sit within the system, and POCT under ISO 15189 if staff also work outside the laboratory.