Shanghai Change Enterprise Management Consulting Co., Ltd.
Tel:021-64938244,64934915
Fax:021-64934398
Unified national service hotline:400-888-2590
Mobile:18019093972
Mail:690608054@qq.com
URL:www.shchange.com.cn
Shanghai Change Enterprise Management Consulting Co., Ltd.
Tel:021-64938244,64934915
Fax:021-64934398
Unified national service hotline:400-888-2590
Mobile:18019093972
Mail:690608054@qq.com
URL:www.shchange.com.cn
According to the compliance model system, most directives allow manufacturers and their representatives to choose one or a combination of models to show compliance with directives. Generally speaking, there are three ways of conformity.
1. Self-declaration
Applicable to products that do not require verification. Self-declaration needs to be evaluated by the manufacturer or verification agency in accordance with the applicable directives and harmonization standards. In addition, the self-declaration needs to include the preparation of the declaration form and attach the CE mark.
2. Verification
a) Compulsory verification (EC type verification) Most products and machinery do not require mandatory verification; however, some specific products require a verification certificate issued by the EU certification body; there are also some specific products, such as machinery and medical products , An EC type verification certificate is required.
b) Voluntary verification (type verification, test mark) manufacturers often entrust EU verification agencies to conduct tests and verifications to prove that they meet market needs, and provide positive and factual proof of product liability, and they also have technical file information The accuracy of the test report and the confirmation of the test report are also beneficial to product marketing. Spontaneous verification also requires the manufacturer to prepare a declaration of conformity and additional CE marking. BSCI factory audit.
3. Technical documents
All compliance modes require technical documents, which should include the following:
Declaration of conformity (and/or verification certificate of regulated product);
Manufacturer’s name, address and product identification;
The name and address of the agent in Europe;
List the harmonized standards followed, and/or measures to meet the basic safety and health requirements·Product description (model, product name, etc.);
Operation Manual;
The overall plan of the product;
testing report;
Design details, operation description, component list, test theory basis, circuit diagram, including all necessary items to meet basic requirements such as health and safety.
The manufacturer or the EU representative is solely responsible for the correctness of the technical documentation and the declaration of conformity. The manufacturer must implement internal operations to ensure that the product maintains its compliance. After the next batch of products are manufactured, the technical documents should be kept in an area for at least ten years for inspection.
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