on the scope of documentation of the supplier of IVD and laboratory instruments in the context of the requirements of ČSN EN ISO 15189 ed. 3:2023 and Regulation (EU) 2017/746 (IVDR) by the Czech Institute for…
The Czech Accreditation Institute (CAI) reminds all medical laboratories with accreditation according to ČSN EN ISO 15189 ed. 2:2013 that, in accordance with the ILAC resolution, the validity of…
With 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 Czech Accreditation Institute (CAI) hereby draws the attention of representatives of accredited medical laboratories to the fact that the transitional period for the implementation of the requirements ends on February 17, 2024…
The Czech Accreditation Institute (CAI) announces that from December 1, 2023, it will accept applications for the assessment of medical laboratories under ČSN EN ISO 15189…
Czech Accreditation Institute (CAI) is fully prepared to assess medical laboratories according to ČSN EN ISO 15189 ed.3: 2023 from 1 July 2023,…