Subject description
Introduction (fundamentals of technical infrastructure, metrology, accreditation, standardization, conformity assessment) interconnections and specifics;
Concept of quality and standardisation;
Directives and national legislation (transposition, implementation, legislation system);
Standardization (standardization infrastructure, development, types, renewal, standard understanding);
Discussing general (infrastructural) groups of standards (directives for documentation of quality systems and conformity assessment, etc.);
Philosophy of New and Global approach – concept;
Modular approach towards European conformity (CE) marking of products according to standard requirements and preparation of technical documentation;
Quality system management;
Total Quality Management (TQM), problems solving techniques and quality circle;
Procedures and basic tools for quality assurance (control charts, quality function deployment – QFD, failure mode and effect analysis – FMEA, process control – PC, optimal experiment design, etc.);
Quality and standardization in different fields (production, laboratory, service, environment, safety, health, etc.)
The subject is taught in programs
Objectives and competences
Aim of the course is to get acquainted with concrete knowledge on complete establishment and quality assurance of different systems – production and service. In scope of this subject students gather separate knowledge for total quality assurance. In this scope is meant quality system assessment and certification and getting acquainted with tools for achieving best results. Student gets knowledge on solving problems using quality tools. In addition student gets acquainted with reliability, economy, legislation and safety. This fundamentals, which are typically defined by legislation, human protection, environment, market, etc., are upgraded by quality. Students get knowledge on practical examples of quality systems. The final objective of the subject is to be directly involved in the real environment in the field of quality.
Teaching and learning methods
lectures, auditory exercises, laboratory exercises, seminar works, excursion
Expected study results
After successful completion of the course students should be able to:
– explain basic concepts in the field of technical infrastructure, standardization, accreditation, European and national legislation, the creation of a standard
– use all kinds of standards
– describe the accreditation and certification process and the assessment process
– describe the importance of directives, a new and global approach, a CE marking and a modular approach
– describe the procedures before placing the CE mark on the product and the meaning and appearance of the product's technical file
– interpret comprehensive quality management, quality management systems, use of quality assurance tools, QFD and FMEA quality management method
– distinguish between quality by fields (law, products, people and the environment)
– design and carry out concrete technical work in the field of product testing, laboratory work for quality assurance and safety
– prepare and evaluate the experiment,
– prepare quality manual and implement the quality system in accordance with the requirements of the standards
Basic sources and literature
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/
DRNOVŠEK, Janko, BEGEŠ, Gaber, PUŠNIK, Igor. Kakovost sistemov : povzetek predavanj. Ljubljana: Fakulteta za elektrotehniko, Laboratorij za metrologijo in kakovost, 2012.
DRNOVŠEK, Janko, BEGEŠ, Gaber, PUŠNIK, Igor. Kakovost sistemov : laboratorijske vaje. Ljubljana: Fakulteta za elektrotehniko, Laboratorij za metrologijo in kakovost, 2011.
Quality Assurance & Technical Documentation: A Simplified Approach by Evan Aksen, Amazon, 2012Engineering Design for Six Sigma—a systematic approach, Quality and Reliability Engineering International, Volume 26, Issue 4, June 2010, Pages: 317–324, Torben Hasenkamp Feigenbaum
Quality Function Deployment and Six Sigma, Second Edition (paperback): A QFD Handbook (2nd Edition) (QFD Handbooks) by Joseph P. Ficalora and Louis Cohen, Amazon, 2012
Effective FMEAs: Achieving Safe, Reliable, and Economical Products and Processes using Failure Mode and Effects Analysis by Carl Carlson, Amazon, 2012
“Blitz QFD – The Lean Approach to New Product Development.” ASQ World Conference on Quality Improvement. May 2012
VIM – International Vocabulary of Terms in Legal Metrology; 2012
Slovenski inštitut za standardizacijo: SIST EN 45020 – Standardizacija in z njo povezane dejavnosti – Splošni slovar, 2007
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