What is Conformity Assessment?
Within the framework of the New Approach Policy adopted in 1985 in European Union countries, products bearing CE marking have free circulation. The CE mark proves that the products are manufactured in accordance with the relevant directives and standards for human health and safety. It is understood that the products with CE marking are healthy and reliable in terms of human health, plant, animal and environmental conditions. It is not possible for products entering the European Union New Approach Directives cascade published today but without CE marking to enter the European Union market and even to be accepted in world markets.
In determining whether products comply with the New Approach Directives, it is important that manufacturers have produced in accordance with the directives and relevant standards. In the case of production in accordance with the standards, it is assumed that the production has been made in accordance with the relevant directives. For this reason, manufacturing companies must make production in accordance with the standards.
In fact, the CE marking attached to the products is not an indication of the quality of these products. The CE mark only means that all requirements of the relevant regulations are complied with during production activities. However, a natural consequence of this situation is the quality of these products. The main purpose of the CE marking system is to ensure that products are healthy and reliable and to allow free movement between the member states of the European Union. Although the CE marking has emerged in European Union countries, it is a system that is applied all over the world today.
Conformity assessment is an important step in the implementation of the CE marking system. Conformity assessment studies are carried out in eight separate modules, which include different procedures applied for the widest possible product range.
These modules may be of interest to the design work or production work of the products, or both. In general, however, a product is subject to a module conformity assessment during design and production. The New Approach Directives show the extent to which the conformity assessment process will be implemented, which is considered to provide the required level of protection.
Conformity assessment studies based on the eight identified modules can be based directly on the manufacturer or on the third party notified body. It may also be related to the design stage of the product, the production stage or both. The manufacturer is responsible for conducting the conformity assessment for both stages if the design and production work is left to a subcontractor.
These modules are determined depending on the type of product and the risks it carries. Some products are considered low risk and some products are considered as high risk, especially considering the type and importance of the product, the nature of the risk, the economic infrastructure of the sector and similar factors.
New Approach Directives introduce different procedures according to product groups depending on their content.
What is the Declaration of Conformity?
In accordance with the CE marking system, the manufacturer or its representative within the European Union must issue a declaration of conformity or declaration of conformity as part of the conformity assessment processes contained in the New Approach Directives.
The declaration of conformity should essentially cover the following information:
- All applicable directives
- Manufacturer
- Representative in the European Union
- Notified body if necessary
- Product description
- Where possible, references to harmonized standards and other normative documents
In accordance with the New Approach Directives, the declaration of conformity is an obligation when the product is placed on the market. This obligation belongs to the manufacturer or its representative within the European Union.
The declaration of conformity or declaration of conformity means that the product has been manufactured in accordance with the basic requirements of the relevant directives or that it has met the basic requirements of the directive as a result of the type examination.
The European Union declaration of conformity must be retained for at least 10 years starting from the date of manufacture of the product, unless otherwise provided in the relevant directive. This responsibility lies with the manufacturer or its authorized representative in the European Union. In some cases, it is the responsibility of the importer or the supplier of the product.
The scope of the European Union declaration of conformity is determined separately in the directives according to the type of product concerned. The standards issued by the Turkish Standards Institute regarding the declaration of conformity are as follows:
- TS EN ISO / IEC 17050-1 Conformity assessment - Supplier declaration of conformity - Part 1: General requirements
- TS EN ISO / IEC 17050-2 Conformity assessment - Supplier declaration of conformity - Part 2: Supporting documentation
These standards cover the general rules and supporting documents for the declarations of the supplier companies that declare the conformity of the products they provide with certain standards when requested or required. This standard replaces the EN 45014 standard in force.
The declaration of conformity in accordance with this standard shall contain sufficient information to enable the follow-up of all products covered. For example, a declaration of conformity should contain the following information:
- Name and address of the manufacturer or its authorized representative issuing the declaration
- Complementary information about the product, such as product name, type, model number, group or serial number, resources and part numbers
- Legal regulations applied in production activities
- Clearly, precisely and precisely defined, referenced standards and other normative documents such as national technical standards and specifications
- Other complementary information that may be provided, such as the type or category of product, as far as possible
- Date of declaration of conformity
- Titles and signatures of authorized persons
- In addition, a statement on the declaration of conformity explaining that this statement is issued only under the responsibility of the manufacturer or its authorized representative.
- If the notified body is involved in the conformity assessment process, the name, address and identification number of that body
If more than one New Approach Directive is applied to a product, all declarations of conformity of the manufacturer or its authorized representative may be collected in a single document.
