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Quality Management System in laboratories

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Course Unit Code9360-0125/03
Number of ECTS Credits Allocated2 ECTS credits
Type of Course Unit *Choice-compulsory type B
Level of Course Unit *First Cycle
Year of Study *Second Year
Semester when the Course Unit is deliveredSummer Semester
Mode of DeliveryFace-to-face
Language of InstructionCzech
Prerequisites and Co-Requisites Course succeeds to compulsory courses of previous semester
Name of Lecturer(s)Personal IDName
PLA88prof. Ing. Daniela Plachá, Ph.D.
Summary
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
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
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
Required Reading:
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:
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
Lectures, Seminars
Assesment methods and criteria
Task TitleTask TypeMaximum Number of Points
(Act. for Subtasks)
Minimum Number of Points for Task Passing
CreditCredit