The Czech Accreditation Institute (CAI) is fully prepared to assess medical laboratories according to ČSN EN ISO 15189 ed.3: 2023 as of 1 July 2023, the originally set deadline for accepting applications according to this new version of the standard. However, it has not started the accreditation process according to this standard due to the completely unexpected uncertainty regarding the harmonisation of the standard in the European harmonised standards system by the European Commission (EC). Members of the European Organisation for Cooperation in Accreditation (EA) had to respond by postponing the start of providing accreditation according to this standard. The European Accreditation is intensively negotiating with the EC leadership with the aim of quickly resolving the situation within the entire European Union. CAI is finalizing the preparation of rules on how to start providing the service in the above-described situation and enable laboratories to assess according to ČSN EN ISO 15189 ed.3: 2023. We assume that by the end of November this year we will allow entities to apply for accreditation not only according to the existing harmonized standard ČSN EN ISO 15189:2013, but also for assessment of the requirements of the new standard. We believe that the above procedure will allow prepared laboratories to demonstrate compliance with the accreditation requirements of the new standard in accordance with the rules of Regulation (EC) No. 765/2008 of the European Parliament and of the Council.
Although the situation was not caused by CAI, we apologize for any inconvenience.
We will inform you immediately about current developments.