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CE-marking - EU Directives
CE-marking: also import certification for suppliers outside Europe
CE-marking is a mark to indicate that the product on which it is affixed is in conformance with EU Product Safety Directives. These directives apply to all products that are to be put into service inside the European Economic Area (EEA) for the first time. This includes products being manufactured as well as imported. Even used products being imported are subject to CE-marking requirements. NQAQSR-North America can help Manufacturers around the world as well as Importers to assess their products and to declare that they meet European requirements.
For a product that meets the requirements of all applicable directives, the manufacturer or importer shall draw-up and sign a EU Declaration of Conformity. After that, CE-marking has to be placed on the product and/or packaging.
Procedure
Before a manufacturer or importer is allowed to place CE-marking on his product, there are a few steps to be undertaken. Some of the most essential steps are:
- Risk Assessment to verify that the product is safe to use and meets all requirements of the applicable directives.
- Drawing up a Users Manual with instructions for safe usage and warnings for dangers (when applicable).
- Drawing up a Technical File, which content shows that the product meets all applicable requirements.
For the more dangerous products, intervention of a so-called Notified Body, a Conformity Assessment body, is required. There are a number of conformity assessment modules available to the manufacturer or importer to choose from. Some modules are based on testing of every single product; others are based on EC-type approval, sometimes in combination with a quality assurance system (e.g. ISO 9001) evaluation. The Notified Body will assess the Technical File and evaluate the actions and measures taken by the manufacturer or importer. In some cases, depending on the Assessment Module chosen, a physical inspection and test of the product will take place. When the Technical File, the product and the procedure are approved, the Notified Body will issue an EC Type Approval or EC Certificate of Compliance.
Directives
Some of the most commonly applicable directives include :
- Electromagnetic Compatibility Directive
- Machinery Directive
- ATEX Directive
- Personal Protective Equipment Directive
- Low Voltage Directive
- Medical Devices Directive
- Toys Directive
- Pressure Equipment Directive
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