If a manufacturer manufactures its products in accordance with European Union standards and wants to put the CE mark on their products, there are ways to follow this. First of all, the product to be marked CE marked, published by the European Union New Approach Directives 23 product range.
Then the manufacturer needs to prepare a technical file. In this file CE marking product design, production processes and operational information. Technical fileshould be prepared to show how well that product meets the relevant basic requirements. This test file should be kept for ten years starting from the date of product launch, if there is no other provision in the relevant regulation.
The technical file forms the basis of the CE marking studies. As will be explained soon, the technical file must be prepared even if the manufacturer produces a product that is not in the risky class and therefore uses the CE marking authority. If the product enters a risky class, the relevant certification body will already want to see the technical file.
CE Marking System it is very important that the product in question is not included in the risk group. In the CE marking application, the European Union has classified the products according to their risk groups from A to H as follows:
- A: Internal production control
- A1: oversee internal production control and product testing
- A2: Internal production control and product controls with unexpected visits
- B: European Union type examination
- A: European Union type compliance in internal production control
- C1: overseeing European Union type compliance and product testing in internal production control
- C2: European Union type compliance in internal production control and product control with random visits
- D: European Union type conformity based on production quality assurance
- D1: Production quality assurance
- E: European Union type conformity based on product quality assurance
- E1: Quality assurance of final product inspection and testing
- F: European Union type compliance based on product verification
- F1: Compliance based on product verification
- G: Compliance based on unit verification
- H: Compliance based on full quality assurance
- H1: Compliance based on full quality assurance and design review
For low-risk products, the CE conformity assessment is carried out by the manufacturer itself and a declaration declares that the product complies with the mandatory safety, environmental, health and consumer protection standards.
For high-risk products, the products must be inspected by notified bodies. According to the results of this inspection, the manufacturer can put CE marking on the product.
One of the organizations that provide consultancy services on CE Marking System is TURCERT certification organization. For more information on what to do to install this system, or even to obtain a CE Certificate, you can contact the experienced managers and employees of the TURCERT certification body.