1. Phare SL9705.03 1 Implementation of Technical Regulations on Company Level Top Management Seminar Expert: Willem Wolf Chamber of Commerce and Industry, Ljubljana

2. Phare SL9705.03 2 Frequently Asked Questions What is a European Directive when is it applicable is my product subjected how do you comply which standards are imports subjected Top Management Seminar

3. Phare SL9705.03 3 Frequently Asked Questions Is certification obligatory what about national requirements who can assist what are the costs how long does it take Top Management Seminar

4. Phare SL9705.03 4 Member States and the legal structures to accomplish the “Unified Europe” Top Management Seminar EU Legislation

5. Phare SL9705.03 5 Member States EU Austria, Belgium, Denmark, Finland, France,Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden, United Kingdom Top Management Seminar

6. Phare SL9705.03 6 European Economic Area Applicability of Directives European Union + Iceland, Norway and Liechtenstein (Switzerland implements voluntarily) Top Management Seminar

7. Phare SL9705.03 7 TREATY OF ROME, 1957 Art. 100A Art. 118A 95137 Top Management Seminar

8. Phare SL9705.03 8 EC Directives According Art. 100 Realisation of the internal market Transposition in national law without changes According Art. 118A Approximation of laws and regulations Minimum requirements Top Management Seminar

9. Phare SL9705.03 9 Article 100A Why Product directives ? Free movement of goods Safety, Health, Environmental Technical harmonization Top Management Seminar

10. Phare SL9705.03 10 Article 100A By whom ? Brussels (European Commission) order to member states national implementation maximum requirements no differences Top Management Seminar

11. Phare SL9705.03 11 Article 100A For whom ? Manufacturer Importer end user Top Management Seminar

12. Phare SL9705.03 12 Article 118A Social Working environment Safety Health Top Management Seminar

13. Phare SL9705.03 13 Article 118A Why ? Diminish absence through illness occupational disease occupational accidents Top Management Seminar

14. Phare SL9705.03 14 Article 118A By Whom ? Brussels (European Commission) order to member states national implementation minimum requirements, differences allowed Top Management Seminar

15. Phare SL9705.03 15 Article 118A For whom ? Employees Employer Top Management Seminar

16. Phare SL9705.03 16 NEW PRODUCT DIRECTIVES Low voltage EMC Machinery Medical devices ATEX (94/9/EG) CE-marking etc. Top Management Seminar

17. Phare SL9705.03 17 NEW OSH DIRECTIVES Safety at the working place Working devices Working with Visual Display Units ATEX (Draft) etc. OSH - Occupational Safety and Health Top Management Seminar

18. Phare SL9705.03 18 TREATY OF ROME Technical harmonization free movement of prod. safety for the user national implementation maximum requirements No differences manufacturer, Importer end user safety/health of worker national implementation minimum requirements employee/worker employer 100A118A Top Management Seminar

19. Phare SL9705.03 19 NEW APPROACH No technical requirements Only essential requirements references to standards Top Management Seminar

20. Phare SL9705.03 20 DIRECTIVES AIM AT free movement harmonization of laws safety health environment Top Management Seminar

21. Phare SL9705.03 21 NEW APPROACH since 1985 directive per group of products only essential requirements technical requirements by CEN/CENELEC permanent committee (judge standards) publication in the official journal Top Management Seminar

22. Phare SL9705.03 22 New Approach Placing on the market initial action to sell or to use a product in the European community Putting a product into service First use by the final user in the European community Manufacturer Person responsible for design and production Authorized representative Person appointed by the manufacturer to act on his behalf Importer One importing goods into the European community Top Management Seminar

23. Phare SL9705.03 23 STANDARDIZATION activity (process) of establishing provisions (appointments/specifications) for common and repeated use, aimed at the achievement of the optimum degree of order in a given context. Made (drawn up) with consensus by all relevant parties concerned. Top Management Seminar

24. Phare SL9705.03 24 STANDARD (voluntary) agreement between parties with which compliance is not compulsory which is available for the public approved and issued by a recognized body Top Management Seminar

25. Phare SL9705.03 25 STANDARDIZATION AIMS AT fitness for purpose compatibility/interchangeability variety reduction and efficiency (self)regulation of the market elimination of (technical) barriers to trade safety and health protection of the environment Top Management Seminar

26. Phare SL9705.03 26 STANDARDIZATION BENEFITS reduction of enterprise risks serves the competitiveness means market opportunities market oriented application of Know-how Top Management Seminar

27. Phare SL9705.03 27 THE STANDARDS WORLD Top Management Seminar

28. Phare SL9705.03 28 Some important Directives Low Voltage Medical Devices Telecom Terminal Equipment Machinery Explosive Atmosphere EMC Automotive Active Implantable Tractors and agricultural vehicles Pressure equipment... over 47 directives (19 are New Approach) Top Management Seminar

29. Phare SL9705.03 29 CE-marking Compliance with all applicable directives internal quality control system procedure on how conformity is achieved applying the CE-mark retain documentation for 10 years Top Management Seminar

30. Phare SL9705.03 30 CE- marking Top Management Seminar

31. Phare SL9705.03 31 Sanctions Sales embargo liable for all cost of taking products of the market liable for all cost of testing by government (In Holland) Offenses regarded as economic fraud. The (whole) company is defendant. Top Management Seminar

32. Phare SL9705.03 32 STEPS TO CE directive(s) applicable ? harmonized standards self testing test report competent body test report declaration by manufacturer / apply CE-marking CE no yes Top Management Seminar

33. Phare SL9705.03 33 Conformity assessment A. Internal control of production B. Type examination C. Conformity to type D. Production quality assurance E. Product quality assurance F. Product verification G. Unit verification H. Full quality assurance Top Management Seminar

34. Phare SL9705.03 34 Declaration of conformity Name and address of manufacturer Product identification Conformity to directive(s) Notified body (if applicable) Reference to standard(s) (if applicable) Responsibility of manufacturer Top Management Seminar