CE certification evaluation model

CE certification can be said to be the most advanced product conformity assessment model in the world today. It is the first to introduce the concept of modules. The assessment of a product applicable to the CE mark consists of assessment modules and assessment procedures composed of these assessment modules. Generally speaking, there are the following types of assessment modules:

A: Self-declaration (self-declaration by the manufacturer and providing key technical information of the product)

B: Type test (comprehensive product testing by the EU notified body)

C: Factory inspection by the notified body for product production

D: Factory audit by the notified body for product production and its quality management system

E: The notified body reviews the quality management system of traders and other intermediaries

F: The notified body reviews the batch products imported into the EU

G: The notified body conducts a comprehensive review, including type testing, of products imported into the EU that have not yet undergone type testing.

Different directives specify which modules should make up the evaluation procedure. For example, the Low Voltage Directive (LVD) and the Electromagnetic Compatibility Directive (EMC) can be composed of A; the Gas Appliance Directive (GAD) can be composed of BC, BD, BE or BF.

The following can be explained in detail:

1. Factory self-control and certification Module A (internal production control)

1. For simple, large-volume, non-hazardous products, only applicable to manufacturers that apply European standards.

2. The factory conducts self-assessment and self-declaration.

3. Technical documents shall be submitted to national institutions for storage for ten years. On this basis, review and inspection can be used to determine whether the product complies with the directive. The manufacturer shall even provide the design, production and assembly process of the product for inspection.

4. No need to declare that its production process can always ensure that the product meets the requirements.

1. The manufacturer did not produce according to European standards.

2. The testing agency conducts random tests on special components of the product.

2. Review of Module B (EC type review) by the testing agency

The factory sends samples and technical documents to the testing agency of its choice for review, and the testing agency issues a certificate.

Note: B alone is not sufficient to constitute CE use. Module C (same as type [sample]) + B

The factory makes a declaration of conformity (consistent with the certified type) and the declaration is kept for ten years. Module D (production process quality control) + B:

This model focuses on the production process and final product control. The factory produces according to the method approved by the testing agency (quality system, EN29003), and on this basis declares that its products are consistent with the certified type (declaration of conformity). Module E (Product Quality Control) + B

This mode only focuses on final product control (EN29003), and the rest is the same as Module D. Module F (Product Testing) + B

After the factory ensures that its production process can ensure that the product meets the requirements, it makes a declaration of conformity. The recognized testing agency verifies the conformity of its products through full inspection or sampling inspection. The testing agency issues a certificate. Module G (testing one by one) The factory declares that it meets the requirements of the directive and submits the product technical parameters to the testing agency. The testing agency issues a certificate after checking the products one by one. Module H (comprehensive quality control) This mode 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.

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