Primer on Standards - OEK - OVE

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