CE Technical File Preparation

CE technical file preparation is one of the most important stages in the CE Certificate acquisition process. Organizations that want to put their products on the market with the CE mark enter into a certification process, either directly by their own declaration or under the supervision of notified bodies, depending on the scope of certification. Companies applying for a certificate have to do documentation work on issues such as product design, use, tests, compliance verification, declaration of conformity, etc. in this process. Every transaction should be documented and put in the CE technical file. This file is like a summary of the CE certification process and contains information and documents confirming compliance with the directives and standards for which the certification is made. The scope of the CE technical file, which is obligatory to be prepared in each CE certification process, may vary depending on the product to be certified and the scope of the regulation. You can ask all your questions about CE technical file preparation to Aşan Danışmanlık, and you can get detailed information about CE certification steps.

What is CE Technical File?

CE Certificate, which is a prerequisite for supplying products to the EU market, has also been made compulsory for many product groups in our country. Companies obtain CE certification in order to declare that their products meet basic health and safety criteria and comply with product-specific regulations and standards. In the certification process, some documents need to be prepared as a requirement of the regulations and referenced standards. In this context, documents such as the design and production information of the product, the results of the tests and analyzes, the user and safety manuals of the product, the list of the standards and regulations used, the EC declaration of conformity, etc. are brought together to make a documentation work called a technical file. The content of the CE technical file, which is obligatory to be prepared for each product, varies depending on factors such as the type and characteristics of the product, the scope of the regulation, the reference conformity assessment procedure (modules), etc. Manufacturers have to prepare this file, submit it to the relevant authorities and keep it for 10 years in order to obtain the CE Certificate.

How to Prepare CE Technical File?

The technical file is a living document that covers the entire CE certification process. In other words, every work done from the beginning of the process must be documented and included in this file. Although it varies depending on the product and the directive, we can say that a typical CE technical file consists of the following information and documents:

- The intended use of the product; brand and model information, serial and batch number, if any and necessary
- Information about the manufacturer; address, telephone, authority, facility, etc.
- Design documents of the main product and sub-components; technical drawings, schematics, electronic and hydraulic circuits etc.
- Instructions for manufacture, transportation and storage of the product
- Usage, maintenance, installation, repair and repair manuals (whichever or whichever is necessary / mandatory)
- List of regulations and standards referenced and referenced in the certification process
- Reports showing the results of risk analysis, safety and/or performance tests and other studies, if any
- Quality, calibration and usage instruction information of all machinery and equipment used in the production of the product
- EC declaration of conformity
- Information on the notified body;
- Studies carried out under the supervision of a notified body; testing, analysis, inspection, inspection etc.

CE Technical File Consultancy Service

Manufacturers who want to obtain CE Certificate and put their products in the domestic or European market must complete the CE technical file preparation studies. Aşan Danışmanlık provides organizations with the training, consultancy and certification solutions they need in this process. You can get help from Aşan Danışmanlık in all matters related to the CE technical file and complete the certification work quickly and easily. Aşan Consulting plans the certification process from the beginning to the end and provides professional support in the preparation of the information and documents in the technical file.

Aşan Consulting is at your side for CE Technical File Preparation
 
Although the CE Certificate is not a quality or guarantee document, it is a document of primary importance for the product to be presented to the European Union market. In our country, CE Certificate has been imposed directly or indirectly for many product groups with various regulations. Since CE technical file preparation is one of the key steps of this process, companies need consultancy services when they want to obtain CE Certificate and prepare technical files.

Aşan Consulting has proven itself in CE technical file consultancy and has provided consultancy services to many companies from different sectors.