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CE Technical File Preparation

CE Technical File Preparation Consultancy Service

Manufacturers who want to get CE Certificate should get CE technical file consultancy from companies that have expertise and competence in this field. The CE technical file is a comprehensive file containing the information of the company applying for the product and document to be CE marked / branded. The correct preparation and presentation of this file is very important for the correct documentation. The technical file must be kept for a certain period of time (10 years) to be submitted to the relevant authorities and organizations when necessary by the manufacturer, even after the CE Certificate is obtained. For this reason, many companies seek CE technical file preparation consultancy and want this process to be concluded in the most accurate, fast and easy way.

What is CE Technical File?

CE technical file preparation is the most important stage of the CE certification process. In this file, there are many critical information such as technical information about the product, the standards referenced in design and production, documents showing the product´s compliance with the relevant CE regulations, company inspection reports, tests and calculations of the product, and risk analysis studies. In addition, general explanations, quality standards, maintenance and calibration reports of materials and devices used in production; Instructions for processes such as production, storage, logistics, etc. are also included in the CE technical file.
Today, CE Certificate is issued for many product groups such as machinery, medical devices, toys, building materials, elevators, gas appliances, etc. The technical file preparation, which is the most important step of the certification process, confirms that every process, application and operation of the product is carried out within the framework of the relevant regulations. In this context, we can say that the CE technical file preparation constitutes a very large part of the certification process in terms of scope. Although the content of the technical file is common for many product groups, it should be noted that a different CE technical file preparation process is required for each product, as the standards, methods used, tests and analyzes of the product differ. You can learn the answers to many questions such as what is the CE technical file, how to prepare the CE technical file, what should be in the CE technical file, by contacting Aşan Danışmanlık and get detailed information about the process.

How to Prepare CE Technical File?

Companies aiming to obtain CE Certificate for their products should first of all have knowledge about legal regulations. Firms, in accordance with which regulation the CE Certificate should be prepared; then it should determine the standards that the product must meet, the tests that should be done on the product, etc. He/she should learn which conformity assessment module covers the product, which design and production stages this module covers, and whether there is a need for a certifying body within the scope of the relevant module. It should also be noted that if a certifying body is needed, on-site inspections can be organized at the company´s production and/or test sites.
All this information and the studies to be carried out become a part of the CE technical file preparation phase. In this context, we can say that technical file preparation is a living and constantly evolving work. Every work done from the beginning to the end of the certification process is reported directly or indirectly in the technical file.
We can summarize the documents to be included in a CE technical file as follows:

1 -Basic information such as product name, brand, model and intended use
2- Product design information; technical drawing of the product, calculations made in the design, analysis etc.
3- Information such as field of activity, product range, address, telephone, e-mail, etc. of the company that produces the product
4- Test studies and their reports showing that the product does not pose any danger to human health, animals and the environment and confirming its reliability
5- Documents of machinery and equipment used in the design and production of the product; maintenance plans, calibration reports, etc.
6- Instructions for operations such as design, production, quality control, packaging, storage, shipment, etc., belonging to the manufacturer
7- Certificates of the company (quality, occupational health and safety, hygiene, environment, energy, etc.)
8- User manual of the product
9- If the product to be CE certified consists of more than one piece and an installation is required after being sold, an assembly manual should also be included in the CE technical file.
10- A detailed list of the standards used
11- EC Declaration of Conformity; Regardless of whether the notified body is involved in the process, the manufacturer must also include this declaration 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. Having knowledge and experience in all aspects of CE technical file preparation, Aşan Danışmanlık becomes the most reliable business partner of companies in this process. Organizations that want to receive CE technical file preparation consultancy service can get detailed information by contacting Aşan Danışmanlık.