9360-0125/05 – Quality Management System in laboratories (SMK)
Gurantor department | CNT - Nanotechnology Centre | Credits | 2 |
Subject guarantor | prof. Ing. Daniela Plachá, Ph.D. | Subject version guarantor | prof. Ing. Daniela Plachá, Ph.D. |
Study level | undergraduate or graduate | Requirement | Compulsory |
Year | 2 | Semester | summer |
| | Study language | English |
Year of introduction | 2019/2020 | Year of cancellation | |
Intended for the faculties | FMT, USP | Intended for study types | Bachelor |
Subject aims expressed by acquired skills and competences
The aim of the lectures is obtaining fundamental knowledge in the sphere of quality management according to ISO 9001 and ISO/IEC 17025:2018.
Teaching methods
Lectures
Seminars
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.
Compulsory 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
Recommended 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
Way of continuous check of knowledge in the course of semester
The student develops tasks related to the management system.
E-learning
Other requirements
For this subject other requirements for student are not determined.
Prerequisities
Subject has no prerequisities.
Co-requisities
Subject has no co-requisities.
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.
Conditions for subject completion
Occurrence in study plans
Occurrence in special blocks
Assessment of instruction
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