European Union is currently a political and economic organization consisting of 28 member states with a total population of more than 500 million. One of the four basic freedoms granted by this union is the free movement of goods.
CE Marking signifies that the products meet all the requirements of the EU technical regulations and can be circulated among the member states of the EU without facing any technical barriers.
We see capital letters CE on many products in free movement in the European Economic Area. This marking, meaning Conformity with Europe, demonstrate that the products have been audited/assessed in terms of minimum safety, health and environmental requirements. You would see CE marking on a new telephone, food processor, TV set or crayons purchased in the European Community. CE marking also indicates fair competition among manufacturers as it enforces accountability and conformity with the same requirements.
A manufacturer who affixes CE marking to his products, declares that the products are in conformity with all necessary requirements (regulations and standards) and can be sold in the economic area. CE Certificate secures two great advantages for the business world and consumers. The business world acknowledges that products bearing CE marking can be sold in the European Economic Area without facing any barriers, and consumers feel assured that products they purchase meet all essential health, safety and environmental requirements.
It is the manufacturer’s responsibility to carry out conformity assessment of products, to prepare technical files, to acquire CE marking where necessary, to draw up EU Declaration of Conformity, and to affix CE marking to the products.
All conformity assessment procedures (modules) including testing, inspection and/or CE certification must be completed before the product is placed on the market. Manufacturers should confirm the regulations covering their products, and if necessary, should apply to notified bodies designated to give conformity assessment services.
The EU Declaration of Conformity should contain the following information related to the product, manufacturer or representative, notified body where applicable, and harmonised standards:
- Unique identification of product,
- Name and address of manufacturer or authorised representative,
- Statement of sole responsibility of the manufacturer of this declaration,
- Identification of product allowing traceability, clear product photograph where appropriate,
- Relevant European Community directive,
- References to the relevant harmonised standards and/or specifications,
- Where applicable, the name and ID number of the notified body, description of the module and CE certificate information,
- Additional information, signature, name and function of designated signatory, and place and date of issue.
The mark must take the form as seen in the below picture. The proportions must be respected even if the dimensions are changed. The CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents.
WE GIVE CE CERTIFICATION SERVICE FOR THE FOLLOWING EU DIRECTIVES
The EU Directives for which SZUTEST gives testing, auditing, inspection and certification services as the Notified Body No. 2195 or with its partners are as the following:
The essential property of the EU legislation is to ensure high level of health and safety limits of products bearing CE marking. The essential requirements apply to the hazard inherent to a product. That is why, if not laid out in the harmonised standards, manufacturers must perform risk analysis and include the results in their technical files.
While essential requirements indicate the results to be achieved and the hazards to be eliminated, they do not give a clue on technical solutions or how to eliminate these hazards. Manufacturers can reach real solutions and application details using the related harmonized standards or specifications.
EU harmonization legislation imposes on the manufacturers the obligation of preparing a technical file containing information that proves the conformity of their products to the essential requirements and to keep this file for 10 years. The technical file which is under the manufacturer’s or the authorised representative’s responsibility can be a part of the quality system documentation in the quality-system based conformity assessment procedures.
Though the information to be included in the technical file is detailed in every regulation, it is generally the information and documents on the definition, purpose of usage, design, production and operation of the product. You can find detailed information on our website.
Conformity assessment modules cover both the design and production phases. While some cover only one phase, others can do both. Conformity assessment modules consist of 8 main categories:
- Module A, A1, A2 – Internal production control
- Module B – EU-type examination
- Module C, C1, C2 – Conformity to EU-type based on internal production control
- Module D, D1 – Conformity to EU-type based on quality assurance of the production process
- Module E, E1 – Conformity to EU-type based on product quality assurance
- Module F, F1 – Conformity to EU-type based on product verification
- Module G – Conformity based on unit verification
- Module H, H1 – Conformity based on full quality assurance
Notified bodies perform calibration, testing, auditing, inspection and certification activities indicated in the conformity assessment procedures when a third party attestation is required. Notified bodies are designated by notified authorities (related ministries) in terms of the applicable directives, and communicated to the EC.
Notified bodies can deliver conformity assessment services within the EU or in third countries. They must provide information to the notification authority and to market surveillance authorities and carry out their activities impartially, independently, indiscriminatingly and competently. They should have accreditation as proof of their competence.
Accreditation is the attestation of the national accreditation body (TURKAK) of a conformity assessment body to have the technical competence to carry out the related conformity assessment activities as stated in the harmonised standards. The legal framework of the accreditation requirement in EU has been drawn by Regulation 765/2008. Accreditation is very important in ensuring product conformity through well working and trustworthy conformity assessment activities.
SZUTEST has been accredited by TURKAK on the following standards within the scope of EC 765/2008 and 2008/68/EC:
TS EN ISO/IEC 17020 Conformity assessment — Requirements for the operation of various types of bodies performing inspection
TS EN ISO/IEC 17021-1 Conformity assessment – Requirements for bodies providing audit and certification of management systems
TS EN ISO/IEC 17024 Conformity assessment – General requirements for bodies operating on certification of persons
TS EN ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
TS EN ISO/IEC 17065 Conformity assessment – Requirements for bodies certifying products, processes and services