It must be clearly stated from the outset that it is entirely the responsibility of the manufacturer to make a declaration of conformity with the products and to place the CE Mark on the products. Otherwise, any accredited certification body or an authorized laboratory can neither decide on the CE Marking on the products nor issue any CE Certificate or CE Certificate.
However, the New Approach Directives are somewhat complex and manufacturers may have doubts as to which directives or directives are covered and whether they meet the requirements of these directives. It may even require additional testing, analysis and evaluation of products in order to be safe. Only at this point can support from a certification body.
The manufacturer must prepare a technical file for CE product certification studies. This technical dossier is the first thing an official organization will look into when investigating a product or investigating product complaints or security problems. If the technical dossier cannot be provided or if there is no information and documentation to be included, that is, the technical dossier is not suitable, it will be difficult for the manufacturer to account.
The information and documents required in the technical dossier are contained in each CE marking directive. In the first place, the technical dossier should contain the results of an adequate risk analysis and assessment. In addition, the conditions and scope applicable to the assessment of product design, production and operation should be included in this dossier.
In addition, a technical dossier shall include, as far as practicable, at least: a general description of the product, design and production drawings and diagrams of product components, subassemblies, circuits and the like, an understanding of these drawings and diagrams and the necessary explanations for the operation of the product. , design calculations and examination results, test reports and a list of fully or partially harmonized standards published in the Official Journal of the European Union. In addition, if other national and international standards have been considered, a list of these must be included in the technical dossier. The technical dossier should also include a list of other applicable technical specifications and a description of the solutions adopted to achieve the safety objectives.
There is no requirement in the directives that an accredited test laboratory should be used for testing and analysis. However, if the tests and analyzes are performed in a non-accredited laboratory, the burden of proof is that the laboratory tests are performed correctly. Test reports from an accredited laboratory are already reliable and acceptable and are generally not questioned by the authorities.
As a result, manufacturers play an important role in ensuring that the products offered to consumers are safe. They are responsible for checking and ensuring that their products meet the safety, health and environmental protection requirements of the European Union. It is always the responsibility of the manufacturer to carry out the conformity assessment, to draw up the technical dossier, to declare the European Union conformity and to place the CE Mark on the products. Only after this has been done can a product be traded on the European Union market. Customs authorities must regularly check the safety of products. To ensure compliance with CE marking directives, the technical file, including the declaration of conformity, can be checked at any time.
Our company also provides CE product certification services within the scope of certification services. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.
CE product certification services provided within the scope of certification services are only one of the services provided by our organization in this respect. Many other certification services are also available.
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