Course detail

Certification and Technical Standardization

FSI-XCN-KAcad. year: 2011/2012

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.

Language of instruction

Czech

Number of ECTS credits

4

Mode of study

Not applicable.

Guarantor

doc. Ing. Alois Fiala, CSc.

Department

Institute of Production Machines, Systems and Robotics (ÚVSSR)

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

Teaching methods depend on the type of course unit as specified in the article 7 of BUT Rules for Studies and Examinations.

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

Not applicable.

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

Fiala, A. a kol.: Řízení jakosti podle norem ISO 9000,0
Úřední list Evropské unie,0
Ricchiute, D. N.: Audit,0

Recommended reading

Fiala, A. a kol.: Řízení jakosti podle norem ISO 9000,0
Úřední list Evropské unie,0
Ricchiute, D. N.: Audit,0

Classification of course in study plans

  • Programme M2A-K Master's

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

Type of course unit

 

Guided consultation

13 hours, optionally

Teacher / Lecturer

Ing. Petr Koška, Ph.D.

Syllabus

1. Interpretation of basic terms and definitions. Conformity as expression of product
quality. Preparation of conformity demonstration procedures.
2. Legal protection of the customer's rights. Directive 85/374/EEC on liability for the
damage caused by a product. Directive 92/59/EEC on general safety of products.
Mandatory demonstration of conformity in the Czech Republic. Legal protection of the
customer's rights. Act No. 634/1992 Coll. on protection of the consumer, Act No.
59/1998 Coll. on liability for the damage caused by a defective product.
3. Mandatory demonstration of conformity. Technical requirements or products. Technical
regulations in EU.
4. International normalization. Technical standards in the conformity demonstration
process. Systems of technical standards and their utilization in conformity
demonstration. New approach to technical harmozation and standards (Council Resolution
85/C 136/01).
5. Global approach to conformity assesment.
6. Modular system for the conformity assessment.
7. Voluntary demonstration of conformity. Conformity demonstration without participation
of a third party. Conformity demonstration with third-party participation –
certification. 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. Independence, impartiality and credibility of accredited laboratories.
10. Act No. 22/1997 Coll. on technical requirements for products. Government regulations
for individual types of specified products.
11. Technical requirements to machinery (Directive 98/37/EC), principles for risk
assessment.
12. Quality system documentation. Quality manual. Directives. Standard procedures. Quality
plans. The other documents. Procedure in document elaboration. Principles for the
preparation of directives.
13. Declaration of conformity. European conformity mark (CE).


Controlled Self-study

26 hours, compulsory

Teacher / Lecturer

doc. Ing. Alois Fiala, CSc.

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.