Course Unit Code | 9360-0125/03 |
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Number of ECTS Credits Allocated | 2 ECTS credits |
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Type of Course Unit * | Choice-compulsory type B |
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Level of Course Unit * | First Cycle |
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Year of Study * | Second Year |
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Semester when the Course Unit is delivered | Summer Semester |
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Mode of Delivery | Face-to-face |
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Language of Instruction | Czech |
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Prerequisites and Co-Requisites | Course succeeds to compulsory courses of previous semester |
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Name of Lecturer(s) | Personal ID | Name |
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| PLA88 | prof. Ing. Daniela Plachá, Ph.D. |
Summary |
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The aim of the lectures is achieving of knowledge about management quality system laboratories and in the sphere of legislation and standards that are valided and used in this sphere (ISO 9001, ISO/IEC 17025:2005). Lectures are aimed to basic terminology of management quality system, aplications of statistics and metrology in laboratory. |
Learning Outcomes of the Course Unit |
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The aim of the lectures is obtaining fundamental knowledge in the sphere of quality management according to ISO 9001 and ISO/IEC 17025:2018. |
Course Contents |
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1. Introduction to quality management: Basic concepts, quality management system policy, elements of quality management system, legislation.
2. Set of ISO 9001 standards, basic terms and meaning for society.
3. Standard ISO / IEC 17025: 2018, basic terms, meaning for customers.
4. Good laboratory practice, meaning to achieve high-quality measurement results.
5. Creating a quality management system in laboratories, management requirements, customer support, quality management tools.
6. Technical requirements for test and calibration laboratories.
7. Laboratory Information Systems.
8. Metrology, continuity of measurements, reference materials, importance of continuity to ensure the quality of measurement results.
9. Ensuring the quality of the test and calibration results.
10. Validation of methods - basic concepts.
11. Method of validation of the analytical method.
12. Definition and significance of measurement uncertainty.
13. Procedures for determining uncertainty of measurement.
14. Practical examples of method validation. |
Recommended or Required Reading |
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Required Reading: |
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GOETSCH, D. L., DAVIS, S. B., Quality Management: Introduction to Total
Quality Management for Production, Processing, and Services (4th Edition), Prentice Hall 2002.
MITRA A. Fundamentals of Quality Control and Improvement.John Wiley & Sons, 2012, p. 724 |
ČSN EN ISO/IEC 17025:2005 Posuzování shody – Všeobecné požadavky na způsobilost zkušebních a kalibračních laboratoří.
MESTEK, O., SUCHÁNEK, M.: Kvalimetrie 8. Základy metrologie v chemii. Editor M. Suchánek. EURACHEM-ČR Praha 1998. ISBN 80-901868-5-8.
Kvalimetrie 9. Vhodnost analytických metod pro daný účel. Laboratorní příručka pro validaci metod a související činnosti. Editor M. Suchánek. EURACHEM-ČR Praha 1998. ISBN 80-901868-7-4.
DOŠKÁŘOVÁ, Š., JANOŠ, P., PLZÁK, Z., SUCHÁNEK, M., ŠUBRT, P.: Kvalimetrie 13. Odhad nejistot chemických a mikrobiologických měření. Metodická příručka. Editor M. Suchánek. EURACHEM-ČR Praha 2003. ISBN 80-86322-01-7.
MITRA A. Fundamentals of Quality Control and Improvement.John Wiley & Sons, 2012, p. 724. |
Recommended Reading: |
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JO GILE, T., SCUNGIO, D.: Complete Guide to Laboratory Safety, Fourth Edition. HCPro a division of BLR, 2014.
HOYLE D. Quality Management Essentials. Routledge, 2007, p. 224 |
BIČOVSKÝ, K., DEMPÍR, J., DOHNAL,L., FRIEDECKÝ, B., KRATOCHVÍLA, J., KUČERA, J., PLZÁK, Z.: Kvalimetrie 14. Návaznost chemických měření. Průvodce k dosažení srovnatelných výsledků chemických měření. Používání referenčních materiálů v chemické analýze. Editor M. Suchánek. EURACHEM-ČR Praha 2004. ISBN 80-86322-02-5;
Dokumenty MPA, vydané ČIA o.p.s.;
GOETSCH, D. L., DAVIS, S. B., Quality Management: Introduction to Total Quality Management for Production, Processing, and Services (4th Edition), Prentice Hall 2002. |
Planned learning activities and teaching methods |
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Lectures, Seminars |
Assesment methods and criteria |
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Task Title | Task Type | Maximum Number of Points (Act. for Subtasks) | Minimum Number of Points for Task Passing |
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Credit | Credit | | |