C5145 Quality management in bioanalytical laboratory

Faculty of Science
Autumn 2025
Extent and Intensity
1/1/0. 2 credit(s) (plus extra credits for completion). Type of Completion: zk (examination).
In-person direct teaching
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 10:00–11:50 C12/311
Course Enrolment Limitations
The course is offered to students of any study field.
Abstract
The aim is to 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
Key topics
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.
Study resources and literature
    recommended literature
  • 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
  • CHROMÝ, Vratislav; Miroslava BITTOVÁ; Jan HAVLIŠ; Markéta KAJABOVÁ; Vladimír KOMÁREK; Petr SCHNEIDERKA and Miroslav VOTAVA. Bianalytika - Analytické metody v klinické chemii a laboratormí medicíně. 2nd ed. Brno: Masarykova univerzita, PřF, Ústav chemie, 2011, 331 pp. ISBN 978-80-904539-3-7. info
    not specified
  • ČSN EN ISO 15189 (85 5101) (Variant.) : Zdravotnické laboratoře - Zvláštní požadavky na jakost a odbornou způsobilost : česká technická norma. info
  • 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
Approaches, practices, and methods used in teaching
Set of lectures and practice
Method of verifying learning outcomes and course completion requirements
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 2022, Autumn 2023, Autumn 2024.
  • Enrolment Statistics (recent)
  • Permalink: https://is.muni.cz/course/sci/autumn2025/C5145