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Information on the harmonization of the standard ČSN EN ISO 15189 ed. 3:2023

The publication of Commission Implementing Decision (EU) No. 2024/581 on a harmonised standard for the accreditation of medical laboratories in support of Regulation (EC) No. 765/2008 of the European Parliament and of the Council in the Official Journal of the European Union on 20 February 2024 resulted in harmonization of ČSN EN ISO 15189 ed. 3:2023.  Therefore, starting from this day, the Czech Accreditation Institute, a public benefit corporation, may, upon the request of an entity, carry out accreditation independently according to this harmonized standard.  

If you have any questions, please do not hesitate to contact the responsible CAI staff. You can find their contacts here: https://www.cai.cz/?page_id=2008

CAI is responsible for the content and accuracy of the information in the Czech version; the English version is provided for guidance only (automatic translation), and in case of any discrepancies, the Czech text shall prevail.