Harmonized Standards and the EC Directives

Product compliance requires an understanding of the goals of, and the methodology for achieving, compliance.

The goals are explained in the laws, known as directives... The ways to achieve the goals are explained in the technical rules, known as harmonized standards (ENs).

The goals are explained in the laws, known as directives. The various directives define the essential requirements. The ways to achieve the goals are explained in the technical rules, known as harmonized standards (ENs). The directives and standards should be considered together with a focus on standards for the product's design and assessment criteria. The most important consideration must be on protecting the consumer (user, operator, buyer, etc.), which in turn limits risks to the product manufacturer and supplier. Presumption of Conformity - This is a phrase associated with products that comply with the relevant European harmonized standards. National enforcement authorities are obliged to recognize that equipment manufactured in conformity with the harmonized standards, published in the Official Journal of European Communities and transposed into national standards, are presumed to conform to the essential requirements of the directives. When a product is not in compliance with the appropriate ENs, a presumption of conformity does not exist. The directives tell us why we must comply and what may happen if we ignore the laws. But it is the ENs that show us how to comply (design and assessment) by providing guidelines. To clarify, ENs are not mandatory, but the fulfillment of the essential requirements of the directives is mandatory. There are three primary areas in which ENs are concerned:

• The Quality and Competence of the Bodies responsible for
• Accreditation
• Testing
• Certification
• Surveillance (i.e.: EN45000)
• The Quality and Competence of Manufacturers (i.e.: ISO 9000)

The Quality, Safety and Reliability of Products (i.e.: EN/HD Product Standards)

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