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Quality Management System in laboratories

Type of study Bachelor
Language of instruction English
Code 9360-0125/05
Abbreviation SMK
Course title Quality Management System in laboratories
Credits 2
Coordinating department CNT - Nanotechnology Centre
Course coordinator prof. Ing. Daniela Plachá, Ph.D.

Subject syllabus

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.

Literature

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

Advised literature

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