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Lecturer(s)
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Turková Sedláčková Terezie, Ing. Ph.D.
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Vlas Tomáš, Ing. Bc.
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Course content
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Lectures 1. Correct laboratory practice, definitions, terms, origin, history. Decree No. 163/2012 Coll., on principles of good laboratory practice and instructions of the Ministry of the Environment of the Czech Republic - National program for monitoring compliance with GLP principles. 2. ČSN ISO EN 15 189 and ČSN ISO EN 17025. 3. Act No. 296/2008 Coll. and Decree No. 404/2008 Coll. 4. Quality systems and their implementation in healthcare. Certification and accreditation of laboratory methods. 5. Pre-analytical phase of the sample. Preanalytical manual and examination database. 6. Laboratory manual and operating regulations of the laboratory. Hygienic rules, OSH and PO. 7. Metrology. 8. Standard Operating Procedures (SOP). Technical and abbreviated SOP (T-SOP and ZSOP). 9. Internal quality control. External quality control systems. Validation, verification, continuity and comparability of measurements. 10. Quality control of work and results in the laboratory. Documentation management, archiving and data protection. 11. Nonconforming Work and Remedies. Quality objectives, new methods and their evaluation. 12. Audit and its contribution in the quality management system. 13. Waste management, Waste Act. Seminars 1. Certification of laboratory methods. 2. Work quality control. 3. Quality control in the laboratory. 4. Creation and management of good laboratory practice documents. 5. Planning new methods and managing work in the laboratory. 6. Basic conditions of quality assurance in the laboratory, minimum personnel and technical equipment. 7. Quality and risk management methods (Ishikawa diagram, six sigma, FMEA, FTA), determination of possible risks in the laboratory, their prevention and solutions. 8. Ensuring metrological quality in the laboratory and related documentation, prevention of measurement errors, measurement conditions, ISO 15189. 9. Documents for accreditation of the laboratory, necessary documentation, quality manual in the laboratory. 10. Management of processes in the laboratory. 11. Preparation of the document SOPV, SOPT 12. Workplace audit according to ISO 15189. 13. Credit test
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Learning activities and teaching methods
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- Contact hours
- 65 hours per semester
- Preparation for comprehensive test (10-40)
- 15 hours per semester
- Preparation for an examination (30-60)
- 30 hours per semester
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| prerequisite |
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| Knowledge |
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| specific knowledge prerequisites are not required |
| Skills |
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| specific skill prerequisites are not required |
| Competences |
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| N/A |
| learning outcomes |
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| Knowledge |
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| explain the concept of good laboratory practice (GLP), the reason for its introduction, purpose and principles |
| defines the requirements related to the laboratory accreditation/laboratory method certification process |
| lists the types and areas of audits |
| Skills |
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| he/she is expressed in terms associated with the quality management process |
| Competences |
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| N/A |
| teaching methods |
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| Knowledge |
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| Lecture with visual aids |
| Skills |
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| Seminar |
| Field trip |
| Competences |
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| Lecture with visual aids |
| Seminar |
| assessment methods |
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| Knowledge |
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| Oral exam |
| Test |
| Skills |
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| Oral exam |
| Competences |
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| Oral exam |
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Recommended literature
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ČSN EN ISO 15189 ED. 2 (855101) - Zdravotnické laboratoře - Požadavky na kvalitu a způsobilost..
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ČSN EN ISO/IEC 17025 (015253) - Všeobecné požadavky na kompetenci zkušebních a kalibračních laboratoří..
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Vyhláška č. 163/2012 Sb., o zásadách správné laboratorní praxe..
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Vyhláška č. 404/2008 Sb, o způsobu zhotovení některých druhů hotově baleného zboží, jehož množství se vyjadřuje v jednotkách hmotnosti nebo objemu..
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Zákon č. 296/2008 Sb., o lidských tkáních a buňkách..
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PEŠEK, Jaromír. Tvorba systému jakosti ve zdravotnictví a lékárenství s využitím norem ISO.. Praha : Grada, 2003. ISBN 80-247-0551-6.
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