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Lecturer(s)
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Beránková Zuzana, Mgr. Ph.D.
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Course content
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Introduction to quality management systems (the importance of quality in laboratory services, the concept of quality management and continuous improvement). Legislative framework (EU Directive 98/79, the Act on Medical Devices and implementing regulations, ISO 15189, and other requirements for clinical laboratories). Laboratory accreditation (the national accreditation system for clinical laboratories (NASKL), the accreditation process and surveillance audits, the role of professional societies in developing accreditation standards). Quality management system in the laboratory (description of the quality system and processes in the laboratory manual, development of standard operating procedures, corrective and preventive actions). Method validation and verification (requirements, evaluation of validity, inter-laboratory comparison testing). Documentation management (system, revision and archiving, auditing, access rights).
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Learning activities and teaching methods
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unspecified
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Learning outcomes
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The course focuses on quality management systems in clinical and healthcare laboratories. It addresses the requirements of international and national standards, the legislative framework, and the laboratory accreditation process. Students will gain an overview of the development of internal regulations, standard operating procedures, and control mechanisms to ensure laboratory quality. Seminars are oriented toward practical aspects using examples from clinical laboratory practice.
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Prerequisites
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unspecified
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Assessment methods and criteria
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unspecified
Pass credit test to 50%
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Recommended literature
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ČSN EN ISO 15189:2023 Zdravotnické laboratoře - Požadavky na kvalitu a způsobilost..
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Matýšková, Miloslava; Zavřelová, Jiřina; Matýšek, Stanislav. Systém managementu jakosti: využití v laboratoři. 1. vydání. NCO NZO (IDV PZ), 2002. 87 s. ISBN 80-7013-367-8..
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