On July 18, 2024, the Cabinet of Ministers of Ukraine approved Resolution No. 830, which amends the Procedure and Criteria for Authorization of Accredited Laboratories, including reference laboratories, and the Procedure for Checking Compliance of Authorized Accredited Laboratories, including reference laboratories, with the criteria for authorization and revocation of such authorization, approved by the Cabinet of Ministers of Ukraine on January 10, 2019, No. 10.
The changes are aimed at improving the criteria and procedure for authorizing accredited laboratories, including reference laboratories, for conducting laboratory tests (examinations) of samples taken within the framework of official control.
The criteria for authorizing accredited laboratories, including reference laboratories, have been updated in accordance with the requirements of Regulation (EU) No. 2017/625 of the European Parliament and the Council.
Special attention is paid to the criteria for authorizing reference laboratories, which must be leading laboratories in a specific field and coordinate the work of the network of laboratories authorized by the competent authority for laboratory tests (examinations) in relevant types (areas) of laboratories, as is done in the EU.
Thus, during the authorization of accredited laboratories, including reference laboratories, special attention will be paid to the availability of qualified personnel on the techniques of laboratory tests (examinations) in the relevant types (areas), as well as to the criteria for the effectiveness of methods (techniques) of laboratory tests (examinations) that the authorized accredited laboratory, including the reference laboratory, intends to use for conducting laboratory tests (examinations) of samples taken within the framework of official control measures.
At the same time, an additional and outdated requirement, which is not provided for by EU legislation for the national reference laboratory – the presence of accreditation for compliance with the requirements of the DSTU EN ISO/IEC 17043:2017 or EN ISO/IEC 17043:2010 standard – is eliminated.
Clear mechanisms are introduced for the procedure of authorizing accredited laboratories, including reference laboratories, and the procedure for checking the compliance of authorized accredited laboratories, including reference laboratories, with the criteria for authorization and revocation of such authorization.
Please note that the resolution of the Cabinet of Ministers of Ukraine No. 830 of July 18, 2024, comes into force one month from the date of its publication.
