C5145 Quality management in bioanalytical laboratory

Faculty of Science
Autumn 2022
Extent and Intensity
2/0/0. 2 credit(s) (plus extra credits for completion). 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
Mon 9:00–10:50 C12/311
Course Enrolment Limitations
The course is offered to students of any study field.
Course objectives
In 12 two-hour lectures introduce to students legislation, rules and laws that are obligatory for the quality control in bioanalytical laboratories
Learning outcomes
Basic knowledge of organization in bioanalytical laboratory;
understanding of terms related with quality control;
knowledge of rules and standards related with quality control in bioanalytical laboratory;
knowledge of requirements for certification/accreditation of method/laboratory
Syllabus
  • 1. Introduction to quality management 2. Rules and laws in Czech Republic and EU concerning bioanalytical laboratory 3. Laboratory management, incl. personal management, principles of documentation for hospital laboratory. 4. Methods in laboratory medicine (definitive, reference, routine), expert panels in IFCC. 5. Characteristics of analytical methods. Requirements for analytical method validation and user verification. 6. Quality control in laboratory medicine (internal and external control, limits). 7. Preanalytical, analytical and postanalytical stages in bioanalytical laboratory. 8. Analytical uncertainty. Reference materials. 9. Laboratory certification according to ISO. 10. Accreditation, ČIA and relation to EU. 11. Quality manager and metrologist, function cumulation. 12. Laboratory organization, documentation, examples of protocols.
Literature
  • ČSN EN ISO 15189 (85 5101) (Variant.) : Zdravotnické laboratoře - Zvláštní požadavky na jakost a odbornou způsobilost : česká technická norma. info
  • ISO normy
  • SUCHÁNEK, Miroslav, Zbyněk PLZÁK, Pavel ŠUBRT and Ivan KORUNA. KVALIMETRIE 7. Validace analytických metod. Praha: EURACHEM-ČR, 1997, 137 pp. ISBN 80-901868-2-3. info
  • Péče o jakost. Praha: Úřad pro normalizaci a měření, 1982. info
Teaching methods
Set of lectures
Assessment methods
Final written examination
Language of instruction
Czech
Further Comments
Study Materials
The course is also listed under the following terms Autumn 2007 - for the purpose of the accreditation, Autumn 2010 - only for the accreditation, Autumn 2005, Autumn 2007, Autumn 2008, Autumn 2009, Autumn 2010, Autumn 2011, Autumn 2011 - acreditation, Autumn 2012, Autumn 2013, Autumn 2014, Autumn 2015, Autumn 2016, autumn 2017, Autumn 2018, Autumn 2019, Autumn 2020, autumn 2021, Autumn 2023, Autumn 2024.
  • Enrolment Statistics (Autumn 2022, recent)
  • Permalink: https://is.muni.cz/course/sci/autumn2022/C5145