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

Phare SL 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

Phare SL 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

Phare SL Member States and the legal structures to accomplish the “Unified Europe” Top Management Seminar EU Legislation

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

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

Phare SL TREATY OF ROME, 1957 Art. 100A Art. 118A Top Management Seminar

Phare SL 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

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

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

Phare SL Article 100A For whom ? Manufacturer Importer end user Top Management Seminar

Phare SL Article 118A Social Working environment Safety Health Top Management Seminar

Phare SL Article 118A Why ? Diminish absence through illness occupational disease occupational accidents Top Management Seminar

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

Phare SL Article 118A For whom ? Employees Employer Top Management Seminar

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

Phare SL 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

Phare SL 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

Phare SL NEW APPROACH No technical requirements Only essential requirements references to standards Top Management Seminar

Phare SL DIRECTIVES AIM AT free movement harmonization of laws safety health environment Top Management Seminar

Phare SL 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

Phare SL 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

Phare SL 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

Phare SL 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

Phare SL 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

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

Phare SL THE STANDARDS WORLD Top Management Seminar

Phare SL 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

Phare SL 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

Phare SL CE- marking Top Management Seminar

Phare SL 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

Phare SL 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

Phare SL 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

Phare SL 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