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Accreditation of medical laboratories

Accreditation of a medical laboratory means the assessment of conformity of the laboratory’s qualitymanagement 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 and primary sample collection specified in a scope specified in the Accreditation Certificate.

What is the accreditation based on?

  • ČSN EN ISO 15189:2013 Medical laboratories – Requirements for quality and competence
  • MPA 10-02-17 Guidelines for accreditation according to standard ČSN EN ISO 15189:2013 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 10-02-17 , 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 10-02-17, 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:

Milena Lochmanova +420 272 096 239, +420 730 196 221, lochmanovam@cai.cz

Alena Zemanova +420 272 096 198, +420 727 983 602,  zemanovaal@cai.cz

FOR ALL VALID CAI GUIDELINES (MPA), CAI SERVICES PRICE LIST, LIST OF ACCREDITED ENTITIES AND OTHER INFORMATION, SEE www.cai.cz.