Conformity Assessment


The conformity assessment is divided in modules, which are applicable for a wide area of products.

The modules refer to the stage of product design, the stage of production process or both together. As a rule a product is subject to conformity assessment according to a module as well at the stage of product design as at the stage of production process. Each directive describes the range and content of possible conformity assessment procedures assuming that they ensure the necessary protection level. The directives also lay down the criteria for the possibilities under which the manufacturer can choose, if more than one is applicable.

Application of standards for quality assurance systems

The application of quality assurance systems for conformity assessment procedures in the frame of directives is described in the modules D, E and H as well as in their variations. While fulfilling standards ISO 9001, 9002 and 9003 it is assumed that conformity exists with the relevant quality assurance modules regarding the regulations covered by the respective standard. This under the assumption that the specific requirements of the respective products are taken into account at the quality assurance system as far as necessary.

In order to be in conformity with the applicable directives the manufacturer has to assure that the quality assurance systems satisfies fully the relevant essential requirements,

EC declaration of conformity

The manufacturer or his authorized representative established within the Community has to issue an EC-declaration of conformity in the frame of a conformity assessment procedure envisaged in the directives of the new approach.

The EC-declaration of conformity should comprise all necessary information on the directives on which it is based, the manufacturer, his authorized representative, the notified body if applicable and name the product as well as refer to harmonized standards or other normative documents.