Syllabus
1st Introduction: A brief overview of the development of quality assurance, basic terms of quality management concepts, principles and tools of quality management in an analytical or medical laboratory. 2nd Management systems: basic terms, accreditation, certification, accreditation system for testing and medical laboratories – procedure for accreditation according to ISO/IEC 17025 and ISO 15189 in Czech Republic. Principles of documents control.
Standard operation procedure (SOP). Risk management.
Tasks of quality manager. 3rd Quality management systems: The OECD Good Laboratory Practice, Good Manufacturing Practice, certification according to ISO 9001, their main features, compared with the accreditation and applications in the analytical or medical laboratory, inclusion in the international framework. 4th Development and standardization of analytical methods (chemical measurement procedures), using of the standard procedures for routine analyses. 5th Validation of analytical methods (procedures), validation of instrumentation and software. Verification. 6th Quality control: aims, tools, types of control samples, proficiency testing, risks. 7th Control charts: purpose, types, construction, method of use, statistical process control. 8th Metrology in chemistry, legal metrology, metrological traceability and its specifics in chemistry. 9th Reference materials (RM), types of RM, usage of RM, comparing the measured and certified values of CRM, commutability of RM. 10th Instrumentation, confirmation, calibration and qualification of instrumentation.
Categorization of measuring devices. Metrological assurance of analytical laboratory. 11th Uncertainty of the results of analytical measurements: purpose, use, relationship of an error and uncertainty, evaluation ways, presentation of results, the impact of uncertainty on the comparison of a result with limits.
Annotation
Principles and basic methodology of management of chemical measurements in analytical laboratories, metrology in chemistry, standardization, testing, accreditation and certification. Approaches for estimation of measurement uncertainty.