C5145 Quality management in bioanalytical laboratory

Faculty of Science
Autumn 2010 - only for the accreditation
Extent and Intensity
2/0/0. 2 credit(s) (fasci plus compl plus > 4). Type of Completion: zk (examination).
Teacher(s)
prof. Ing. Vratislav Chromý, CSc. (lecturer)
Mgr. Miroslava Bittová, Ph.D. (lecturer)
Guaranteed by
prof. RNDr. Viktor Kanický, DrSc.
Department of Chemistry – Chemistry Section – Faculty of Science
Contact Person: prof. Ing. Vratislav Chromý, CSc.
Course Enrolment Limitations
The course is offered to students of any study field.
Course objectives
12 lessons introduce students with legislation, documents and laws that are obligatory for the quality management in professional analytical laboratory.
Syllabus
  • 1. Introduction about quality management 2. Laws in Czech Republic and EU concerning analytical laboratory and bioanalysis 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 analyticla method validation and user verification. 6. Quality control in laboratory medicine (internal and external control, limits) (E). 7. Preanalytical, analytical and postanalytical stages in bioanalytical laboratory. 8. Analytical uncertainty. Reference materials (E). 9. Laboratory certification according to ISO (E). 10. Akreditation, CIO and relatino to EU (E) 11. Quality manager and metrologist, function cumulation (E). 12. Laboratory organisation, documentation, examples of protocols (E).
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
lectures
Assessment methods
The block is devided into 12 lectures (1 hour).
Language of instruction
Czech
The course is also listed under the following terms Autumn 2007 - for the purpose of 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 2022, Autumn 2023, Autumn 2024.