EMMK1011s Quality Management - seminar

Faculty of Medicine
spring 2025
Extent and Intensity
2/0/0. 4 credit(s). Type of Completion: zk (examination).
Teacher(s)
Mgr. Miroslava Bittová, Ph.D. (lecturer)
Guaranteed by
Mgr. Miroslava Bittová, Ph.D.
Department of Chemistry – Chemistry Section – Faculty of Science
Supplier department: Department of Chemistry – Chemistry Section – Faculty of Science
Timetable
Tue 18. 2. 9:00–10:40 B11/211, Tue 25. 2. 9:00–10:40 B11/211, Tue 4. 3. 9:00–10:40 B11/211, Tue 11. 3. 9:00–10:40 B11/211, Tue 18. 3. 9:00–10:40 B11/211, Tue 25. 3. 9:00–10:40 B11/211, Tue 1. 4. 9:00–10:40 B11/211, Tue 8. 4. 9:00–10:40 B11/211, Tue 15. 4. 9:00–10:40 B11/211, Tue 22. 4. 9:00–10:40 B11/211, Tue 29. 4. 9:00–10:40 B11/211, Tue 6. 5. 9:00–10:40 B11/211, Tue 13. 5. 9:00–10:40 B11/211, Tue 20. 5. 9:00–10:40 B11/211, Tue 27. 5. 9:00–10:40 B11/211
Prerequisites (in Czech)
EMAR0933c Methods of Assisted Reproduction III-practice
Course Enrolment Limitations
The course is only offered to the students of the study fields the course is directly associated with.
fields of study / plans the course is directly associated with
Course objectives
“The course aims to familiarize students over the course of 15 lessons with the functioning of medical facilities, related international and national standards, and the basic requirements for quality management systems.”
Learning outcomes
"After completing the course, the graduate will: Gain a general overview of the basic principles of quality management system; Become familiar with basic concepts for working in a bioanalytical laboratory; Be able to navigate basic normative documents necessary, for example, for the accreditation of a medical facilities; Understand the requirements for performing the role of a quality manager in a medical facility; Be able to navigate the procedures for creating controlled documentation; Know the procedures for internal and external quality assessment of analyses performed in a healthcare laboratory."
Syllabus
  • 1. Introduction to quality management systems, quality of products and service, quality in medicine 2. System of standards in the Czech Republic, ISO 9001, certification process 3. Accreditation in medicine, standard EN 15224 4. Legal standards and quality management in tissue establishments (Decree No. 422/2008 Coll., Act No. 296/2008 Coll.) 5. Internal quality evaluation, external quality assessment, ISO 19011, auditing of management systems 6. Medical devices, Declaration of Conformity, Adverse Event Reporting System 7. Metrology, metrologist 8. Controlled documentation, management responsibilities 9. Medical documentation, GDPR, informed consent 10. General procedures - sampling, storage, waste disposal 11. Risk management in medicine 12. Bioanalytical laboratory organization - biological variation, reference intervals, IVD medical devices 13. Bioanalytical laboratory organization - accreditation ISO 15189, internal quality control, external quality assessment 14. Bioanalytical laboratory organization - method validation and verification, reference in clinical laboratory, metrological traceability
Literature
    recommended literature
  • ČSN EN ISO 15189 (85 5101) (Variant.) : Zdravotnické laboratoře - Zvláštní požadavky na jakost a odbornou způsobilost : česká technická norma.
  • ČSN EN ISO/IEC 17025 (01 5253) (Variant.) : Všeobecné požadavky na způsobilost zkušebních a kalibračních laboratoří : česká technická norma.
  • CHROMÝ, Vratislav, Luděk DOHNAL, Alena FISCHEROVÁ, Eva KLOKOČNÍKOVÁ, Josef KRATOCHVÍLA, Zdenek KUBÍČEK, Miloš POLLAK, Milena RIKANOVÁ, Petr SCHNEIDERKA, Luděk ŠPRONGL, Dana TRÁVNÍČKOVÁ and Jan VILÍMEC. Management kvality v analytické a klinické chemii (Quality management in analytical and clinical chemistry). první. Brno: Masarykova univerzity, Brno, PřF, Ústav chemie, 2009, 215 pp. ISBN 978-80-903732-6-6. info
Teaching methods
seminary with 100% compulsory participation
Assessment methods
written exam
Language of instruction
Czech
Further comments (probably available only in Czech)
Study Materials
General note: Povinná 100% účast.
Information on the extent and intensity of the course: 30.
  • Enrolment Statistics (recent)
  • Permalink: https://is.muni.cz/course/med/spring2025/EMMK1011s