Subject description
International standardization and compatibility of products, services and processes for regulated and voluntary field: basic principles of metrology systems and standardization, organization of the accreditation organization, certification systems, review of European technical legislation, control and analyses of active quality systems, ISO and EN standards, basic knowledge on preparation of laboratories; Development and realization of basic SI units, physical constants, hierarchical organisation of metrology systems;
International compatibility, metrology development, elements of formal measurement theory, symbolical representation, information contents, measurement theory, measurement error and measurement uncertainty analyses, classification of errors;
Calibration, etalons, basic of quantum metrology, reference materials, processing and evaluation of measurement results, testing, calibration, measurement system parameters; Quality control, quality assurance, total quality assurance, quality costs, bad quality costs, organizational knowledge, business functions and processes, administration management, decision-making, coordination, systems and planning techniques, quality information systems, products and services quality;
Become aware of modern quality assurance techniques with examples of interlaboratory comparisons, risk assessment in testing procedure evaluation and preparation of optimal experiment;
The process of adopting new standards in the field of medical instrumentation (procedures, clinical validation, risk analysis);
The subject is taught in programs
Objectives and competences
The goal of the course is to inform and qualify candidates with knowledge of total quality management, from assesment througt certification of quality sistems, dealing with technical quality and become aware of tools for attaining success. Student gain knowledge on metrology of physical, chemical and physiological quantities, principles and prevailing techical practices in measurement and measurement uncertainty and measurement result analises. Candidate become aware of reliability, safety, economy and energy efficiency, legislation and environment problematics related to quality.
Teaching and learning methods
Lectures with practical examples, seminar, individual work
Expected study results
After successful completion of the course students should be able to:
– explain and interpret basic concepts in the field of technical infrastructure with emphasis on metrology
– design and carry out concrete technical work in the field of testing, laboratory work for quality assurance and safety
– prepare and evaluate an optimal experiment
– design and establish a comprehensive quality management system
– distinguish between quality by fiels (law, products, people and the environment)
Basic sources and literature
[1] Pham D T, Oztemel E (1996) Intelligent Quality Systems. Springer-Verlag, Berlin
[2] Montgomery D C (2001) Introduction to Statistical Quality Control, 4. th edn. John Wiley & Sons Inc, New York
[3] Marlow A J (2005) Quality control for Technical Documentation, Amazon
[4] Regtien P P L (2004) Measurement Science for Engineers. Sterling: Kogan Page Science, London
[5] www.sist.si, www.iso.org, www.iec.ch, www.iecee.org, www.cenelec.org, www.itu.int, www.cenorm.be, www.gov.si/sa, www.ilac.org, www.mirs.si, www.euramet.eu, www.wto.org, www.ansi.org, http://ts.nist.gov, www.conformityassessment.org, www.wssn.net, www.oiml.org, www.asq.org, http://ec.europa.eu/enterprise/newapproach/