NIST SP 951
A Guide to EU Standards and Conformity Assessment
Conformity Assessment: The Module Decision
The Module Decision (90/683/EEC) set out the criteria and guidelines for conformity assessment procedures to be used in the New Approach Directives. The General Guidelines are as follows and are taken directly from the document as it appeared in the Official Journal of the European Communities No. L 380/14, dated December 12, 1990:
- the essential objective of a conformity assessment procedure is to enable the public authorities to ensure that products placed on the market conform to the requirements as expressed in the provisions of the directives, in particular with regard to the health and safety of users and consumers;
- conformity assessment can be subdivided into modules which relate to the design phase of products and to their production phase;
- as a general rule a product should be subject to both phases before being able to be placed on the market if the results are positive;
- there are a variety of modules which cover the two phases in a variety of ways. The directives shall set the range of possible choices which can be considered by the Council to give the public authorities the high level of safety they seek, for a given product or product sector;
- in setting the range of possible choices open to the manufacturer, the directives, will take into consideration, in particular, such issues as the appropriateness of the modules to the type of products, the nature of the risks involved, the economic infrastructures of the given sector (e.g., existence or non-existence of third parties), the types and importance of production, etc. The factors that have been taken into account must be explicitly spelled out by the Commission in these directives;
- the directives will, in setting the range of possible modules for a given product or product sector, attempt to leave as wide a choice to the manufacturer as is consistent with ensuring compliance with the requirements;
- The directives will set out the criteria governing the conditions in which the manufacturer shall choose the most appropriate modules for his production from the modules laid down by the directives;
- the directives should avoid imposing unnecessarily modules which would be too onerous relative to the objectives of the directive concerned;
- notified bodies should be encouraged to apply the modules without unnecessary burden for the economic operators. The Commission, in cooperation with the Member States, shall ensure that close cooperation is organized between the notified bodies in order to ensure consistent technical application of the modules;