Course detail

Certification and Technical Standardization

FSI-XCNAcad. year: 2015/2016

The subject of Certification and technical standardization is to familiarize the students with technical and organizational procedures which form bases for the mandatory or voluntary demonstration of conformity. The acquired knowledge will enable them to prepare quality processes and systems and their documentation for the assessment in form of audits, or to work as process or quality system auditors.
Technical requirements for products. Harmonization of technical regulations in EU. Global conception for the testing and certification. Accreditation of testing laboratories and certification bodies. Technical requirements for products in the Czech Republic. Relationship to acquis communnautaire (EU). Technical regulations in the Czech Republic. Czech Republic accreditation system. Documentation of the quality system according to ISO 9000. Quality manual. Directives. Standard procedures. Quality records and other documents.
Internal audits of company quality systems. Requirements put on internal auditors. Internal audit preparation, performance and documentation.
After successful completion of this course, students will be able to:
- Approaches to quality, environment and BOZ;
- Basic legislative acts in the field of quality, environment and BOZ;
- Explain the benefits of quality, environmental and BOZ,;
- Design a template-driven documentation;
- Identify processes in the organization and propose maps of each of the identified processes and process map (systemic approach);
- Apply simple approaches to the identification and assessment of environmental aspects and risks BOZ;
- Identify the causes of simple problems in the systems of quality, environmental and BOZ and propose remedial measures
-International research Quality

Language of instruction

Czech

Number of ECTS credits

3

Mode of study

Not applicable.

Learning outcomes of the course unit

The subject of certification is to familiarize the students with technical and organizational procedures which form bases for the mandatory or voluntary demonstration of conformity and also explain the basic principals of technical normalization and exercise in technical practice on the national, European and international level. The student will be able to work with technical regulations, to compile sets of technical documents mandatory for the conformity assessment emphases on the changes, which came into being after EU accession. There are elaborated technical certificated systems as authorization (national regulation), notification (European regulation), accreditation and all the kinds of certification. The subject covers technical normalization and its basic methods in technical practice in use from the point of view of technical trade devices elimination, safety and protection of the personal health, consumer and environment protection, particularly the optimal processes, products and services quality.

Prerequisites

Quality management systems (ISO 9001). Technical standardization - aplication of harmonization standards for declaration of conformity. Technical document for products.

Co-requisites

Not applicable.

Planned learning activities and teaching methods

The course is taught through lectures explaining the basic principles and theory of the discipline. Exercises are focused on practical topics presented in lectures.

Assesment methods and criteria linked to learning outcomes

Conditions for getting a classified credit: Delivery of a project – activity with a product conformity assessment (CE declaration of conformity). Specific terms and conditions are always stated at the beginning of the semester.

Course curriculum

Not applicable.

Work placements

Excursions in selected company.

Aims

The acquired knowledge will enable the students to prepare quality processes and systems and their documentation for the assessment in form of audits, or to work as process or quality system auditors. There are explained subject as a technical requirements for products, harmonization of technical regulations in EU, basic program documents EU as a Global conception for the testing and certification, the New approach and Modular conception. This information can help the students with orientation in the complicated structure of law and technical regulations in the EU, emphases on the benefits for the Czech subjects and on possible risks reduction. The purpose of the subject is that the students will realize the importance of demonstration of conformity on the basis of the harmonized technical regulations and standards for successful product launching.

Specification of controlled education, way of implementation and compensation for absences

According to the study plan: obligatory - practical classes (CE declaration of conformity, risk analysis).

Recommended optional programme components

Not applicable.

Prerequisites and corequisites

Not applicable.

Basic literature

Příručka pro zavádění směrnic založených na Novém přístupu a Globálním přístupu. Sborník technické normalizace. ÚNMZ, Praha 2000.
Fiala, A. a kol.: Management jakosti s podporou norem ISO 9000. Verlag Dashöfer, Praha 2006. ISBN 80-86229-19-X..
Baumruk, J. a kol.: Analýza rizik při práci. Fortuna, Praha 2001. ISBN 80-7071-183-3.
Certification and related activities (český překlad Certifikace a příbuzné činnosti). ČSNI, Praha 1995. ISBN 80-85111-36-5.

Recommended reading

Directive 2006/42/EC of the European parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (Text with EEA relevance); Official Journal of the European Union No. L 157/24; pp 63
Guide to application of Directive 2006/42/EC on machinery;2nd Edition, June 2010, General Editor Ian Fraser, European Commission Enterprise and Industry, pp 406
Internal Market and Industrial Cooperation - Statute for the European Company - Internal market White Paper, point 137 (memorandum from the Commission to Parliament, the Council and the two sides of industry); COM(88) 320, June 1988, pp 21
Completing the Internal Market: White Paper from the Commission to the European Council (Milan, 28-29 June 1985) COM(85) 310, June 1985; pp 96

Classification of course in study plans

  • Programme M2I-P Master's

    branch M-KSB , 1. year of study, summer semester, compulsory

Type of course unit

 

Lecture

26 hours, optionally

Teacher / Lecturer

Syllabus

1. Interpretation of basic terms and definitions. Conformity as expression of product
quality.
2. Legal protection of the customer's rights.
3. Mandatory demonstration of conformity. Technical requirements on products.
4. International normalization.
5. Global approach to testing and certification.
6. Modular system for the conformity assessment.
7. Voluntary demonstration of conformity. Certification of products, quality systems, personnel.
8. European accreditation system. European certification systems. Conformity certification in the world.
9. Activity of accredited testing laboratories and their function in the certification
process.
10. Act No. 22/1997 Coll. on technical requirements for products.
11. Technical requirements to machinery (Directive 2006/42/EC)
12. Quality system documentation. Quality manual.
13. Declaration of conformity. European conformity mark (CE).


Exercise

13 hours, compulsory

Teacher / Lecturer

Syllabus

1. Declaration of conformity procedures – general fundamentals, setting a project .The suitability of the standards in assurance of conformity systems.
2. Harmonized standards. Demonstration of conformity harmonized standards application. Harmonized standards, link.
3. Normalization documents, used in quality systems. Individual documents building.
4. Bibliographic citations. Texts writing.
5. Technical documentation of the product, specifications.
6. Government regulation No. 24/2003 Coll. for technical requirements of mechanical appliances determination.
7. Government regulation No. 17/2003 Coll. for technical requirements of electrical appliances determination.
8. Harmonized standard in use of demonstration of conformity of the products.
9. Excursion in testing laboratory, certification body.
10. Discussion about the excursion - authorized (notified) body activity knowledge.
11. Technical documentation made for declaration of conformity analysis.
12. Risk analysis of the product.
13. The project presentation.