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In 1985 the EC Community adopted a “New Approach to Technical Harmonization and Standards”. To promote free movement of goods within Europe it agreed to gradually removed the product regulatory and safety requirements of each individual country and replaced them with essential requirements to cover all of Europe. These essential requirements are contained in various EC product directives and detailed in harmonized European (EN) Standards.
Directives were first published by the EC Commission with an implementation date by which time each country must introduce its own legislation. Most directives then had a transition period during which time manufacturers could choose to meet the directive requirements or continue to market products previously approved or acceptable under the old nation rules.
When products were shown to meet the essential requirements of the directive or harmonized EN standard the manufacturer put the appropriate CE mark on the product.
National Governments cannot stop the sale of CE marked products for safety reasons. At the end of the transition period CE marking was made mandatory and now it is a criminal offence to offer for sale products not meeting the essential requirements. So, for example, all toys for sale in Europe are CE marked. CE marking covers all products manufactured in the EC or elsewhere for sale or use in Europe. From 1k/1/9 these rules were applied to all EC and most EFTA countries, UK, Franc, Germany, Ireland, Spain, Portugal, Italy, Netherlands, Belgium, Luxembourg, Denmark, Greece, Norway, Sweden, Finland, Iceland and Austria. Some other third countries without their own stringent safety standards are now seem to be asking for CE marking.
Products Covered
From 1/1/95 many new approach product directives have been introduced starting with the Toy Directive on 1/1/90. It is estimated that, about 20% of all manufactured goods are covered by such directives, those products with important safety or efficiency features.
Attestation
The method by which the manufacture shows that products satisfy the essential requirements is known as Attestation. When the attestation is complete the CE mark can be used. The EC commission has adopted a modular approach to these procedures, which is generally followed by most directives. The module or modules chosen are appropriate for the degree of safety. Often directives contain several classes of product for which different attestation routes have been chosen. For example, gardening gloves required only manufacturer’s self-certification, whilst a heart pacemaker requires design approval and a full quality system from an independent certification body called notified body.
In all the more critical products the manufacturer often has the choice of attestation route between annual independent testing and a certified quality system. Although most directives follow a common format, product categorization, the attestation route and CE marking rules are different in each directive.
When the intervention of an independent testing or certification body is mandatory, the body must be based in the EC and mush be approved and ‘Notified’ to the EC Commission. These notified bodies are either:
Test or Inspection Bodies undertaking testing inspection and reviews of technical documentation and Certification Bodies undertaking quality systems certification to ISO 9000 or EN 46000.
Notified bodies must be accredited or assessed to the appropriate EN 46000, independent, appropriately insured and acceptable to the national government.
The main types of notified bodywork will be given in subsequent parts of article and vary for each directive. It should be noted the ISO 9000 Certification from a non-notified body is not sufficient to satisfy some modules. A notified body must undertake an assessment.
So what is the conclusion? Next article will discuss this aspect.
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