CE – Marking Technical File
CE – Marking Technical File PDF Print E-mail
Thursday, 26 November 2009 13:22

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In a globalized environment there is a need to establish minimum requirements for the production and marketing of those products that safety is especially critical.

The European Union has adopted a series of European Directives which lay down standards for specific product categories and make mandatory the CE Mark to release these products in the European Economic Area, either the manufacturer is located inside or outside E.U.

But what is the CE Mark? It is a statement made by a manufacturer that the product complies with European Union standards for safety and health of consumers or the environment, as defined in the relevant European Directives.
Some of products requiring CE marking under the European legislation are listed below:
  • Low Voltage Equipment
  • Simple pressure vessels
  • Games
  • Construction Products
  • Electromagnetic Compatibility
  • Personal Protective Equipment
  • Instrumentation
  • Medical Equipment
  • Appliances burning gaseous fuels
  • Hot water boilers with liquid or gaseous fuels
  • Explosives for civil use
  • Pleasure crafts
  • Elevators
  • Cameras
  • Diagnostic medical devices in vitro
  • Radio and Telecommunications Terminal Equipment
  • People Transport facilities moving with cables
  • Environmentally friendly design of products that consume energy

 

But how can a manufacturer obtain the right to mark his products with the CE Mark? The general steps followed are:

1. Recognition of European Directives related to the product.
2. Recognition of the product category in accordance with the criteria specified in the relevant European Directives.
3. Tests on product samples.
4. Compose technical documentation to prove compliance by the manufacturer with the requirements of European Directives.
5. Depending on the type of product, inspection by the "Notified Body" which will certify the adequacy of technical documentation and proper implementation may be required.
6. Application to the "Competent Authority" for inclusion on the register of manufacturers, after which the manufacturer has the right use the CE Mark.
7. Periodic reassessment of the manufacturer to retain the right to use the CE Mark.

 

PRIORITY, having the experience of more than 800 certified management systems in all sectors of the economy is able to lead manufacturers in identifying their needs for new operating practices covering the requirements of European Directives, to prepare the necessary procedures of technical documentation, train the personnel to implement the procedures, verify the proper maintenance procedures, offer special software eQualSuite for the computerized process management, and guide manufacturers through the application process.