Czech Accreditation Institute, a public benefit corporation (CAI) hereby draws the attention of representatives of accredited medical laboratories to the fact that on 17. 2. 2024 the transitional period for the implementation of the requirements of the mandatory document EA-4/17 M: 2022 Description of the scope of accreditation for Medical Laboratories, incorporated in the Czech environment into the Instructions for processing Annex No. 3 of the application and into MPA 00-09-23 Flexible scope of accreditation, ends. An accredited medical laboratory, in accordance with its declared commitment to permanently meet the accreditation requirements, must, on the occasion of the nearest surveillance event (i.e. regular surveillance, extraordinary surveillance, or assessment in connection with a request for a change) after the specified date, request the CAI to issue an Accreditation Certificate and attach a draft Annex to the Accreditation Certificate prepared in accordance with the Instructions for processing Annex No. 3 as amended (https://www.cai.cz/?page_id=2969).
CAI is also pleased to inform representatives of accredited medical laboratories that the Czech version of the standard ČSN EN ISO 22367:2020 Medical laboratories - Application of risk management to Medical laboratories was published in December 2023. This standard, which is referenced as a suitable source of details and guidance on risk management in both ČSN EN ISO 15189 ed. 2:2013 and ČSN EN ISO 15189 ed. 3:2023, thus becomes significantly more user-friendly; it is appropriate to take its content into account, especially during preparation for reassessment according to ČSN EN ISO 15189 ed. 3:2023.
If you have any questions, please do not hesitate to contact the relevant CAI staff (contact details are listed on https://www.cai.cz/?page_id=2008)