Primer on Standards - OEK - OVE

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Some other products, mostly those involving higher risks for both consumers andworkers, cannot be certified by the manufacturer only. They must undergo oneor more of the modules for Conformity Assessment foreseen in the Global Approachto Conformity Assessment involving the intervention of an independent third party:a Notified Body.Notified BodiesNotified Bodies are independent test houses or certification bodies that carry outthe Conformity Assessment procedures referred to in the applicable New ApproachDirective. Notified bodies are designated and notified by each Member State andmust have the necessary qualifications, not only technical but also independence,impartiality, and integrity to meet the testing and/or certification requirementsset by the Directives. Certificates issued by a Notified Body in one MemberState must be accepted throughout the European Union.The Commission publishes a list of Notified Bodies in the Official Journal of theEuropean Communities for information purposes. This list is constantly updatedand can be obtained directly from the Commission services.Otherwise, you may access online information from the Europa website at:http://www.europa.eu.int/comm/enterprise/ticqa/db_index.htmor from the EOTC website, the European Organization for Conformity Assessment at:http://www.ticqa.eotc.beTICQA is a very complete database that allows searches of Notified Bodies combiningdifferent criteria such as “product to be tested” “country” “sector of activity” or“test type”.Conformity Assessment in the New ApproachConformity Assessment is any activity concerned with determining directly orindirectly that the relevant requirements set by the New Approach Directives arefulfilled. This process can be carried out with or without the use of standards.Conformity Assessment may vary in levels of complexity depending on the levelof risk associated with the product being assessed. If the risk factor of the productis low and/or if harmonized standards have been used to meet the essentialrequirements of the New Approach Directives applying to it, then, no third party42 CENELEC. <strong>Primer</strong> on Standards
Conformity Assessment procedure may be required, regardless of the origin orlocation of the manufacturer. In this case, he may directly declare, once thenecessary product evaluations have been performed through the Declaration ofConformity, that the product meets the essential requirements of the Directive(s)that govern it.As the risk for consumers and workers increases, the level of complexity of theConformity Assessment process increases. Some New Approach Directives describethe range and content of possible Conformity Assessment procedures, which areconsidered to give the necessary level of protection and among which themanufacturer can make a choice.The Global Approach to Conformity AssessmentIn Europe, the goal of the New Approach Directives was to eliminate differencesbetween national laws, thereby eliminating barriers to trade between the EUMember States. But barriers were still visible, particularly between testing andcertification procedures. This is the reason behind the creation of an integratedpolicy for technical harmonization that had to be implemented. This scheme wascalled Global Approach to Conformity Assessment. Its main feature is the factthat it incorporated harmonized Conformity Assessment procedures within theNew Approach Directives.The Global Approach was completed by Council Decision 90/683/EEC, replacedand updated by Decision 93/465/EEC. This Decision lays down the guidelines forthe use of Conformity Assessment procedures in technical harmonization Directivesas well as harmonizes the rules for the affixing and use of the CE Marking.These guidelines range from self-declaration by the sole manufacturer to adeclaration by the manufacturer combined with third party certification by aNotified Body, depending on the nature and risk factor of the product. The GlobalApproach provides evaluation that a product has been tested and verification ofthe compliance of the product for sale in Europe.The Manufacturer’s roleThe manufacturer is the person ultimately responsible for designing, manufacturingand the compliance of a given product. Even if certain facets of the productionor components of his product are outsourced, he is the one who must ensure itscompliance with the European legislation relating to it.More often than we may think, the products to be introduced in the EuropeanUncovering the mysteries of standardization in Europe 43
Page 1: Primer on Standard
Page 4 and 5: ContentsIntroductionChapter 1Introd
Page 6 and 7: IntroductionThis primer is intended
Page 8 and 9: ChapterIntroducingCENELECCENELEC, t
Page 10 and 11: CENEL, the European Committee for t
Page 12 and 13: The Central Secretariat handles all
Page 14 and 15: Documents used as a basis for CENEL
Page 16 and 17: ChapterThe EuropeanStandardWhat is
Page 18 and 19: European trade and consumers. Havin
Page 20 and 21: CENELEC Standards are of the highes
Page 22 and 23: ChapterUnderstandingthe CenelecStan
Page 24 and 25: In the case of a European standard
Page 26 and 27: New work arises at European level v
Page 28 and 29: ChapterThe CenelecConformityAssessm
Page 30 and 31: Mutual Recognition Agreements signe
Page 32 and 33: ChapterThe EuropeanStandardization
Page 34 and 35: Legal framework of the New Approach
Page 36 and 37: The Role of European Standards in N
Page 38 and 39: New Approach Directives for which C
Page 40 and 41: ChapterCE Marking, ConformityAssess
Page 42 and 43: egardless of the product’s origin
Page 46 and 47: Market are governed by one (or some
Page 48 and 49: manufacturers are often approached
Page 50 and 51: COOPERATING PARTNERSAIECAPIELCEACEC
Page 52: For more information:35 rue de Stas

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