Quality management system in medical laboratories industry
Students Name: Lutsyshyn Khrystyna Ihorivna
Qualification Level: magister
Speciality: Quality, Standardization and Certification
Institute: Institute of Computer Technologies, Automation and Metrology
Mode of Study: full
Academic Year: 2020-2021 н.р.
Language of Defence: ukrainian
Abstract: Master work is devoted to the study of quality management in the field of laboratory medicine and to a detailed study of the basic guiding standards of laboratory practice. The first section analyzes the formation of the quality of services of clinical diagnostic laboratories according to DSTU ISO 9001. In particular, organizational competence and social responsibility for the activities of the medical laboratory. The second section examines the formation of the quality of services of clinical diagnostic laboratories according to DSTU ISO 17025. The requirements for the technical competence of the laboratory and the procedure for determining the suitability of methods to ensure the reliability of the results are described in detail. The third section considers the formation of the quality of services of clinical diagnostic laboratories according to DSTU ISO 15189, which is responsible for professional medical competence. Risk management methods and their minimization are described. Validation and verification of measurement methods are analyzed. In the final section, an economic justification for the expediency of such a study was conducted and the expenses for the thesis work were calculated.