CE Certificate is an arrangement that ensures the free movement of a product within the borders of the European Union (EU). Products with this document meet certain criteria and comply with the requirements of the directive in the category in which they are located. The abbreviation of Conformité Européenne, which is a French expression (compatible with Europe), CE is one of the first documents that are looked at when entering a product into EU countries.
One of the biggest misconceptions about the CE Certificate thinks that this document expresses a quality standard. However, the CE Certificate shows that it does not contain any harmful content on issues such as human, animal, environment and safety, not the quality of the product. It states that the manufacturer gives guarantee in this regard and provides the necessary conditions in terms of the material and production methods of the product. Organizations who want to have CE Certificate can get CE Certification service from organizations that are accredited in this regard.
What is CE Certification Service?
In order for a product to have a CE mark, a certain process must be followed. The difficulty and duration of this process depends on the characteristics of the product. For example, there is no need to get support from any CE Certification organization for a low-risk product. All necessary testing, analysis, documentation and certification process for the product are done by the manufacturer himself. However, the products that are in high risk class should be contacted with the CE Certification Bodies approved by the EU and completed the necessary accreditation process.
Even if the manufacturer does the CE Certification on his own, he has to carry out all the necessary tests regarding the product and prepare the documents in the legislation. The manufacturer should be able to provide this information as soon as possible in processes such as export, sales, distribution, stock etc., when a problem arises with the product or when any person or institution involved in this process requests information. For this reason, one of the most important parts of the CE Certification process is the technical file preparation, before the product is released to the market. Even if there is no certification service on the subject, support can be obtained from a consulting firm for the preparation of this file and all other procedures.
CE Certification Scope
There are many products that are in the scope of certification. There is a CE directive for each product or product group. Some of these directives are:
Medical devices directive (93/42 / EEC)
• Machinery directive (2006/42 / EC)
• Personal protective equipment directive (Regulation (EU) 2016/425)
• Measuring instruments directive (2014/32 / EU)
Safety components directive for elevators and elevators (2014/33 / EU)
• Simple pressure vessels directive (2014/29 / EU)
Toy safety directive (2009/48 / EC)
• Marine equipment directive (2014/90 / EU)
For detailed information about these directives and other directives that are subject to CE Certification, the European Commission´s (EC) website can be visited.
How is CE Certification Made?
If it is desired to obtain a CE Certificate for a product, it is useful to get support from a consulting firm on the subject. These companies, who are experts in their fields and have provided consultancy services to many businesses in this field, ensure that the process is completed in the shortest time and accurately. Together with the consultancy firm, after making the necessary preparations for the certification process, it can apply to the certification body.
We can list the basic steps of the CE Certification process as follows:
• Contacting the consulting firm
• Preparation of all technical information about the product
• Determination of CE directive related to the product
• Determination of the risk class of the product according to the directive
• Research of national or international standards related to the product
• Determination of the tests, analyzes and technical controls to be performed according to the risk group of the product.
• Getting support from accredited test institutions for tests to be carried out on the product; Preparation of reports after tests
• Preparation of a production document and a list of work orders related to the production of the product, if it is not yet ready.
• Creating the user manual of the product
• Preparation of the CE declaration of the product
• Creating a technical file containing all necessary documents (This file should be kept for at least 10 years, whatever)
CPoints to Consider in E Certification
There are many organizations providing training, consultancy and certification services on CE Certificate. Each of these organizations has a different service policy and tariff. Unfortunately, it is not possible to say that each of them does business within the legal lines. In other words, there are organizations that provide CE Certification service to many companies although they are not accredited. At this point, it will be beneficial for organizations that will receive services to choose companies that offer reliable and quality services. Otherwise, when it is understood that the CE mark is not legal, situations such as product picking from the market and penalty for the manufacturer may arise. Therefore, support should be obtained from companies with legal permissions and experience.
Keywords: CE Certification
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