Accreditation of medical laboratories is carried out according to the accreditation standard ČSN EN ISO 15189 ed. 3:2023 Medical laboratories - Requirements for quality and competence. The requirements of this standard are specified in the relevant methodological guide MPA 10-02-26 "On the application of ČSN EN ISO 15189 ed. 3:2023 in the accreditation system of the Czech Republic".
The basic steps of the accreditation process (application submission, assessment process, surveillance visits) and the associated administrative activities are described in the document MPA 00-01-.. "Basic rules of the accreditation process". Document MPA 00-02-.. The "Regulatory Basis of the Accreditation Process" contains an overview of all documents used in the accreditation process of medical laboratories, including documents from EA and ILAC. The requirements for the implementation and application of the flexible scope of accreditation are set out in the document MPA 00-09-24 "Flexible Scope of Accreditation".
Specific requirements for staffing of medical laboratories are set out in the Decree Ministry of Health 99/2012 Coll.. When assessing the adequacy of staffing of a specific Medical Laboratory, the group of assessors will take into account the type and volume of healthcare provided and the spectrum of performed procedures and activities. The recommendations of professional medical societies of the Czech Medical Laboratory Association (ČLS JEP) have the character of professional recommendations and will be taken into account as such during the assessment.
In special cases, so-called "concurrent accreditation" is possible according to ČSN EN ISO/IEC 17025:2018 and ČSN EN ISO 15189 ed.3:2023. Further information on concurrent accreditation is provided in MPA 00-01-..
Testing of veterinary samples, testing of diagnostics, testing of biological samples for the purpose of determining kinship relationships for reasons other than the purpose of obtaining information for the diagnosis, prevention and treatment of diseases or for the assessment of human health can only be accredited by accreditation standard ČSN EN ISO/IEC 17025:2018.
The principles of accreditation are to be achieved here.
| Position and person responsible for the area | Phone number | |
|---|---|---|
| Guarantor Ing. Vojtěch Jurga | 272 096 201, 702 144 633 | jurgav@cai.cz |
| Guarantor's representative Ing. Alena Zemanová | 272 096 198, 727 983 602 | zemanovaal@cai.cz |
Principles of accreditation of medical laboratories
Information letters
Documents to download
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Accreditation > Laboratories