Infopaket

Quality management system of laboratory research

Обов’язкова дисципліна для ОП

Second

2025/2026

2 Semester

3

Possess and apply knowledge and skills in general and professional training in solving specialized tasks. Argue conclusions and identify connections between modern concepts in the organization of the management process at each stage of professional activity. Demonstrate the deepening of basic knowledge through self-education, demonstrate the ability to present and evaluate their own experience and analyze and apply the experience of colleagues, demonstrate the ability to share experiences with other professionals. Provide counseling related to professional activities. Comply with the requirements of job descriptions, self-improvement. Identify, summarize and solve problems that arise in the process of professional activity and form a sense of responsibility for the work performed. Apply diagnostic methods to measure structural changes and impaired body functions, interpret the information obtained, demonstrating evidence-based decision making.

Full-time form

1. Successful mastery of scientific, theoretical and practical material of academic disciplines taught to students of the "Bachelor" educational level, and special disciplines, such as "Higher Mathematics", "Laboratory Work Techniques", "Selected Sections of Labor Law and Fundamentals of Entrepreneurship", "Occupational Safety in the Industry", "Information Technologies in Medicine and Fundamentals of Statistical Analysis" 2. Knowledge of the theoretical foundations of mathematics and mathematical statistics, computer science, labor protection and management. 3. Ability to apply theoretical knowledge in practice for planning and organizing laboratory research.

Discipline "Laboratory Quality Management System" includes the study of the principles of laboratory service and implementation of quality control at all stages of laboratory research of biological material to develop skills in the organization of laboratory service, features of personnel policy, logistics, intra-laboratory quality control and interlaboratory comparisons, construction of information systems and multilevel internal and external control of medical laboratories.

1. ISO 15189:2022. Medical laboratories – Requirements for quality and competence. Geneva: International Organization for Standardization, 2022. 62 p. 2. ISO/IEC 17025:2017. General requirements for the competence of testing and calibration laboratories. Geneva: International Organization for Standardization, 2017. 30 p. 3. ISO 15190:2020. Medical laboratories – Safety requirements. Geneva: International Organization for Standardization, 2020. 4. ISO 22367:2020. Medical laboratories – Application of risk management to medical laboratories. Geneva: International Organization for Standardization, 2020. 5. ISO 20658:2015. Requirements for the collection and transport of specimens for medical laboratory examinations. Geneva: International Organization for Standardization, 2015.

Lectures, independent work, laboratory classes

Semester assessment: modular tests, practical skills, independent work, solving statistical problems. Final assessment: in the form of a test.

Ukrainian