State Enterprise "Lviv Scientific and Production Center for Standardization, Metrology and Certification" (Lvivstandardmetrology State Enterprise)
Lviv Polytechnic National University

Article deals with topical issues of quality management of medical services and their implementation in practical activity. For quality of research results, serious problems are created by a lot of objective and subjective factors. To eliminate the problem factors, the course was aimed at developing national standards in the field of laboratory medicine, using international experience that regulate the requirements for the organization of clinical diagnostic laboratories and laboratory analysis facilities. The acute problem of laboratory research is to ensure the accuracy of the results. EC has long been required to provide metrological traceability of calibrators, control materials and metrological provision of laboratory equipment, as well as research methods.

Basic requirement for such research is to provide reliable information to the customers. First of all, it defines the requirement for the quality of clinical and diagnostic laboratories studies, which ensures the correct and timely assignment of a patient's analysis, performed at the appropriate analytical level with the necessary information for interpretation. One way to determine the competence of clinic and diagnostic laboratories and the quality of their research is to conduct an independent quality assessment.

[1] ISO EN ISO 15189:2015 Medical Laboratories. Requirements for quality and competence (ENISO 15189: 2012, IDT), [On-line]. Available:

[2] Ministry of Economic Development and Trade of Ukraine. Order "On Approval of the Procedure for Verifying Legislative Instruments of Measuring Instruments in Operation and Designing Its Results", Febr.08, 2016. (In Ukrainian). Registr. Ministry of Justice of Ukraine no.278/28408, Febr.24, 2016,

[3] ISO 9001:2015. Quality management system. [On-line]. Available:

[4] ISO/IEC 17025:2005. General requirements for the testing and calibration laboratories.

[5] A. Petrukh, I. Sydorko, H. Havrylyshyn, “Hematological external quality control studies. Experience interlaboratory comparison results”, Eastern Europe Laboratornaja diagnostika, (in Russian), vol.5, no.1, p.26-31, 2016.

[6] EN ISO/IEC 17024:2012 Conformity assessment - General requirements for bodies operating certification of persons. [On-line]. Available: