EMMK1011p Quality Management - lecture

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)
prof. RNDr. Viktor Kanický, DrSc. (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
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 healthcare laboratories, related normative documents, and the basic requirements for quality management of analytical activities.”
Learning outcomes
"After completing the course, the graduate will: Gain a general overview of the basic principles of quality management; 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 healthcare laboratory; Understand the requirements for performing the role of a quality manager in a bioanalytical laboratory; 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. Introductory lecture on product and service quality, principles of quality management 2. Standards and regulations in the Czech Republic and the EU (ISO 9001), certification process 3. Selected standards and their specifics for analytical laboratories and bioanalytics (ISO/IEC 17025, ISO 15189), laboratory accreditation 4. In vitro diagnostic medical devices, quality management of production (ISO 13485) 5. Analytical methods in clinical chemistry, method characteristics, requirements for validation and verification 6. Metrology, traceability in laboratory medicine, and determination of analytical uncertainty 7. Calibration, control, and reference materials and laboratories 8. Controlled documentation, management responsibilities, quality manager, and metrologist 9. Internal quality control in the laboratory 10. External quality assessment and interlaboratory tests 11. Methods of result evaluation and principles for result release 12. Laboratory organization, forms, calculations 13. Legal standards and quality management in tissue establishments (Decree No. 422/2008 Coll., Act No. 296/2008 Coll.)
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
lecture
Assessment methods
written exam
Language of instruction
Czech
Further comments (probably available only in Czech)
Information on the extent and intensity of the course: 30.
  • Permalink: https://is.muni.cz/course/med/spring2025/EMMK1011p