Train the trainer course on ISO 15189:2022

The EA Train-the-trainer course on ISO 15189:2022?Medical laboratories — Requirements for quality and competence?was held between 6-7 June 2023 (1st?session) and 8-9 June 2023 (2nd?session) in Paris, France. 54 participants from 23 National Accreditation Bodies (NABs) participated in the training. The participants were allocated in two sessions of 27 participants. The training was led by Rolf Straub (SAS, the Swiss NAB), Hélène MEHAY ( COFRAC ), Uwe Zimmermann ( Deutsche Akkreditierungsstelle (DAkkS) , and Rodothea Koniotou (CYS-CYSAB, the Cyprus NAB).

The training intended to focus on the relevant changes of the new standard ISO 15189:2022 and where particular focus is needed.

To have a well-prepared training, a detailed questionnaire elaborated by the trainers was sent to the participants before the training sessions. The questionnaire mainly requested the participants to describe briefly what was not clear and needed further discussion per each clause of the new standard, to include and mention at least two (new) changes per each clause of the new Standard, and to emphasise topics per assigned clause such as:

• a brief overview of the changes.
• documented procedures that shall have been implemented by the laboratory/ evidence to be presented to the assessment team.
• how to assess the identified new points of the standard ISO 15189:2022 in terms of preparation for the assessment, preparation of assessment plan, the content of an assessment, record keeping, and own risk analyses to perform the assessment.
• important information to include in the assessment report to be able to state a proper implementation of the new standard

The training included presentations from the trainers, focusing on the changes of the new standard ISO 15189:2022 per each clause and the outcome of the survey. Questions that resulted from the questionnaire were also highlighted and treated in the workshop groups.

Workshop groups of participants (including group coordinator assignment) were formed for the training. Each workshop group was allocated clauses of the new standard ISO 15189:2022 to evaluate and present in the plenum.

The training sessions and the overview of the new requirements provoked discussions in terms of clarifications of new requirements and what is expected or how to approach the requirement in an assessment. Moreover, the workshop sessions allowed the participants to share their understanding concerning the new requirements of the new standard in terms of how to approach the assessment of new requirements, what is expected, how to prepare for the assessment, the document review, and expectations for an appropriate assessment

In both training sessions, there were very lively discussions either in the groups or during the presentations in the plenum. Some participants confirmed that the topics and views dealt with in the train-the-trainer course correlate very strongly with their own national courses. They felt confirmed that they were on the right track with their preparatory work in the NAB. Furthermore, they found the preparation phase useful for improving their knowledge regarding ISO 15189:2022.