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Testing and certification

* Exchange students do not have to consider this information when selecting suitable courses for an exchange stay.

Course Unit Code040-0094/01
Number of ECTS Credits Allocated4 ECTS credits
Type of Course Unit *Choice-compulsory
Level of Course Unit *First Cycle
Year of Study *Fourth Year
Semester when the Course Unit is deliveredWinter Semester
Mode of DeliveryFace-to-face
Language of InstructionCzech
Prerequisites and Co-Requisites Course succeeds to compulsory courses of previous semester
Name of Lecturer(s)Personal IDName
VEZ01Ing. Hana Věžníková, Ph.D.
Summary
The subject deals with the certification and testing used as a tool for conformity assessment for both regulated and non-regulated areas of products. The subject provides a way to assessment of the safe product properties under the New Legal Framework and European policy to ensure the proper functioning of the single market and the free movement of goods. The subject acquaints with accreditation and authorization systems and their application in testing and calibration laboratories. Attention is also paid to the development of standards within the EU and the Czech Republic. The principles of the certification process are demonstrated on specific products representing the selected product sectors.
Learning Outcomes of the Course Unit
Knowledge acquirement about framework of safe assurance of products placed on the market in EU member states and in Czech Republic. Comprehension of requirements of technical and juridical regulations concerning „safe product“. Application of generally given requirements on particular products or sectors of products. Analysis of duties of producer and user of product.
Course Contents
1. INTRODUCTION TO THE ISSUE
Certification and testing - definition of essential terms, EU policy - single market and free movement of goods, safe product, regulated and non-regulated sphere, consumer and user protection, relationship with environmental protection and OSH.

2. LEGAL REGULATIONS RELATING TO THE SAFETY PRODUCT
Overview of EU and Czech Republic institutions and regulations in relationship to a Safe Product under the New Legislative Framework for the marketing of products, which entered into force on 1 January 2010, definition of basic terms, subject matter and scope of laws.

3. REQUIREMENTS OF TECHNICAL REGULATIONS FOR PRODUCTS
System of EU and CZ regulations, implementing regulations issued for product conformity assessment, sector of specified products, method of determining technical requirements including risk analysis, product matching to harmonisation legislation.

4. CZECH AND FOREIGN STANDARDS
Development, changes, cancellation and publication of Czech technical standards; Czech, European, and International systems of standardization, technical standardization committees and their activities, validity and obligatory character of standards, their harmonization as a means of determining the requirements for a safe product.

5. GENERAL SAFETY REQUIREMENT FOR PRODUCTS AND OBLIGATIONS OF ECONOMIC OPERATORS
Analysis of related regulations - scope and subject matter of the regulation, product requirements, accompanying documentation, obligations of the manufacturer, supplier and distributor, supervisory authorities and their duties, rapid information systems for non-food products.

6. CZECH REGULATIONS RELATING TO THE SAFETY OF PRODUCTS
The overview of regulations to ensure product safety, when placed on the market and when used, with regard to workplace conditions and consumer protection, specified (particularly dangerous) products and their conformity assessment with regulatory requirements.

7. THE MODE OF CONFORMITY ASSESMENT WITH REQUIREMENT ON SAFETY PRODUCT
Modular approach of product conformity assessment, main type of procedures to conformity assessment of product properties to requirements of technical regulations, specified procedure for different sectors of products, use of risk analysis, product quality, and management quality system.

8. THE TESTING AND THE STANDARDISATION
Testing laboratories, their operations and assurance of testing activities quality, the meaning of expressing the uncertainties of measurement results, technical standardisation as means to unity of processes and EU members’ standards, activity control and supervision of state authorities.

9. THE TESTING AND THE METROLOGY
Calibration laboratories, their activities and quality assurance; scientific, industrial and legal type of metrology, international metrological infrastructure, measurement standards, the importance of metrology to remove technical barriers to trade.

10. THE ACCREDITATION AND THE AUTHORIZATION
European accreditation and authorization system, accreditation institutions, state administration tasks, authorization, list of notified bodies, requirements for them, their rights and obligations, accredited bodies, requirements for them, their rights and obligations.

11. THE PRODUCT CERTIFICATION
The definition of certification, certification authorities, certification of products, quality systems or personal, certification activity of authorized bodies and certification authorities, procedures for compulsory and voluntary certification.

12. TECHNICAL DOCUMENTATION OF PRODUCTS, DECLARATION OF CONFORMITY, INSTRUCTION TO USE
The requirements of technical regulations on documentation issued by responsible body, documentation intended for users, declaration of conformity, specific requirements on instruction to use and their importance, product affixing of conformity mark - CE marking.

13. THE RESPONSIBILITY FOR DAMAGE AND THE PRINCIPLES OF SAFE USE OF PRODUCTS
Regulations on responsibility for damage caused by product defect, effective protection of EU consumers and professional users, tasks of state authorities, authorized bodies, and certification authorities in the control of marketing products, Rapid Alert System, the product in relation to the environment, the waste resulting from the operation or use of the product, the packaging, the product life cycle, the disposal of product.

14. RESERVE
Recommended or Required Reading
Required Reading:
2. European Commission.Commission notice The ‘Blue Guide’ on the implementation of EU product rules 2022 (Text with EEA relevance) [online] OJEU 2022/C 247/01. https://eur-lex.europa.eu/legal-content/CS/TXT/?uri=CELEX%3A52022XC0629%2804%29&qid=1672906242094
Evropská komise. SSDĚLENÍ KOMISE „Modrá příručka“ k provádění pravidel EU pro výrobky 2022.(Text s významem pro EHP) [online] Úřední věstník Evropské unie, OJ C 2022/C 247/01. Český překlad. https://eur-lex.europa.eu/legal-content/CS/TXT/?uri=CELEX%3A52022XC0629%2804%29&qid=1672906242094
Recommended Reading:
Borchardt Klaus-Dieter. The ABC of European Union law. Luxembourg: Publications Office of the European Union, 2010. ISBN 978-92-78-40525-0
Borchardt, Klaus-Dieter. ABC práva Evropské unie. Lucemburk: Úřad pro publikace Evropské unie, 2011. ISBN 978-92-78-40726-1
Planned learning activities and teaching methods
Lectures, Tutorials, Project work, Other activities
Assesment methods and criteria
Task TitleTask TypeMaximum Number of Points
(Act. for Subtasks)
Minimum Number of Points for Task Passing
Credit and ExaminationCredit and Examination100 (100)51
        CreditCredit30 10
        ExaminationExamination70 21