Accreditation of a medical laboratory means the assessment of conformity of the laboratory’s quality management system with all requirements of the international standard ISO 15189. The accreditation certificate issued by the national accreditation body is a document confirming the medical laboratory’s competence for examinations, primary sample collection and point-of-care-testing (POCT) specified in a scope specified in the Accreditation Certificate.
What is the accreditation based on?
- ČSN EN ISO 15189 ed. 2:2013 Medical laboratories – Requirements for quality and competence
- MPA 10-02-22 Guidelines for accreditation according to standard ČSN EN ISO 15189 ed. 2:2013 in the accreditation system of the Czech Republic
- ČSN EN ISO 15189 ed. 3:2023 Medical laboratories – Requirements for quality and competence
- MPA 10-02-23 Guidelines for accreditation according to standard ČSN EN ISO 15189 ed. 3:2023 in the accreditation system of the Czech Republic
Other documents related to the accreditation process
All documents are available on the web site of the Czech Accreditation Institute, public service company (CAI).
Time scale and cost of assessment
The cost of the assessment is paid by the applicant. The rules are set out in documents:
- MPA 10-02-22, Annex 2
- MPA 10-02-23, Annex 2
What are the other requirements for the accreditation of medical laboratories?
Direct monitoring of an applicant’s activity on site and assessment of examinations performed under operation (so called “witness audits”) is an integral part of the assessment of applicants.
Selection of examinations to be witnessed must be representative enough, and their minimum number must follow the requirement stated in MPA 10-02-22, Annex 1 and MPA 10-02-23, Annex 1.
Is the accreditation of medical laboratories recognized abroad?
CAI is a full member and represents the Czech Republic in international organizations engaged in the laboratory accreditation:
- European co-operation for Accreditation – EA
- International Laboratory Accreditation Cooperation – ILAC
CAI is the signatory of multilateral agreements on mutual recognition of the results of the accreditation bodies’ activities in their full scopes; i.e. medical laboratory area is covered by:
- EA MLA (Multilateral Agreement)
- ILAC MRA (Mutual Recognition Arrangement)
Who can you ask for further information?
Accreditation program manager and her deputy:
Vojtěch Jurga
+420 272 096 198; +420 702 144 633; jurgav@cai.cz
Alena Zemanová
+420 272 096 198, +420 727 983602; zemanovaal@cai.cz
FOR ALL VALID CAI GUIDELINES (MPA), CAI SERVICES PRICE LIST, LIST OF ACCREDITED ENTITIES AND OTHER INFORMATION, SEE www.cai.cz.
