European co-operation for accreditation (EA) organized a training related to the new version of the standard ISO 15189:2022 Medical laboratories — Requirements for quality and competence, which 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 among there was a representative from ATS. The training intended to focus on the relevant changes of the new standard ISO 15189:2022 in relation to the previous version of the standard ISO 15189:2012.
The participants were allocated in two sessions of 27 participants. The training was led by Rolf Straub (SAS, the Swiss NAB), Hélène Méhay (COFRAC, the French NAB), Uwe Zimmermann (DAkkS, the German NAB), and Rodothea Koniotou (CYS-CYSAB, the Cyprus NAB).
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 point of the standard ISO 15189:2022 in terms of preparation for the assessment, preparation of the 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, as well as the outcome of the survey. Questions that resulted from the questionnaire were also highlighted and treated in the workshop groups.
ATS in the following period plans to organize intensive activities related to the transition of the new version of the standard ISO 15189:2022 accreditation of medical laboratories