CE certification – concept
The “CE” mark is a safety certification mark and is regarded as a passport that the manufacturer opens and enters the European market. CE stands for the European certification logo (CONFORMITE EUROPEENNE). Products bearing the “CE” mark can be sold in EU member states without meeting the requirements of each member state, thus realizing the free circulation of goods within the EU member states. In the EU market, the “CE” mark is a compulsory certification mark. Whether it is a product produced by an enterprise within the EU or a product produced by another country, in order to freely circulate in the EU market, the “CE” mark must be affixed to indicate the product. It meets the basic requirements of the EU Directive on Technology Coordination and Standardization. This is a mandatory requirement for products in EU law.
CE certification can be said to be the most advanced product conformity assessment model in the world. It is the first to introduce the module concept. The evaluation of a product with CE mark is composed of an evaluation module and an evaluation program consisting of these evaluation modules. In general, the evaluation module has the following types:
- Self-declaration (self-declared by the producer and providing key technical information on the product)
- Type testing (comprehensive product testing by the EU notified body)
- Factory review of the production of the product by the notified body
- Factory review of the production and quality management system of the notified body
- The notified body reviews the intermediaries such as traders for the quality management system.
- The notified body reviews the batch products imported into the EU
- The notified body conducts a comprehensive review including type testing for products that have not been type tested in the EU.
Different instructions specify which modules should be used to form the evaluation procedure. For example, the Low Voltage Directive (LVD) and the Electromagnetic Compatibility Directive (EMC) may consist of A; the Gas Appliance Directive (GAD) consists of B-C, B-D, B-E or B-F.
The following can be explained in detail:
First, factory self-control and certification
Module A (internal production control) 1. For simple, high-volume, non-hazardous products, only for manufacturers applying European standard production. 2. The factory conducts self-assessment and self-declaration. 3. The technical documents are submitted to the state agency for ten years. On this basis, the review and inspection can be used to determine whether the product complies with the instructions, and the producer must even provide the product design, production and assembly process for inspection. 4. Do not need to declare that the production process can always ensure that the product meets the requirements.
Module Ab 1. The manufacturer did not produce according to European standards. 2. The testing organization conducts random tests on the special parts of the product.
Second, review by the testing organization
Module B (EC type review) The factory sends samples and technical documents to the testing organization they choose, and the testing organization issues a certificate. Note: Only B is not sufficient to constitute the use of CE.
Module C (consistent with type [sample]) + B factory for conformance statement (consistent with certified version), stated for ten years.
Module D (production process quality control) + B: This mode focuses on the production process and final product control. The factory produces according to the method approved by the testing organization (quality system, EN29003). On this basis, the product is declared to be consistent with the certification type (consistent Sexual declaration).
Module E (Product Quality Control) + B This mode only focuses on the final product control (EN29003), and the rest is the same as Module D.
Module F (Product Test) + B factory guarantees that the production process will ensure that the product meets the requirements and a declaration of conformity. Accredited testing organizations verify the conformity of their products through a full inspection or a sample inspection. The testing organization issues a certificate.
Module G (tested one by one)
The factory declaration complies with the requirements of the directive and submits the technical parameters of the product to the testing organization. The testing organization issues the certificate after checking the products one by one.
Module H (Integrated Quality Control) This model focuses on design, production process and final product control (EN29001). The rest is the same as Module D+Module E. Among them, mode F+B, mode G is suitable for products with particularly high risk products.