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Cerfitication Process & Documentation

Help to write for CE Mark Technical Construction File

Application documents

  1. Application
  2. Technical Construction File (TCF)

TCF shall, wherever applicable, contain at least the following elements

  1. a general description of the product,
  2. conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.
  3. descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,
  4. a list of the harmonized standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonized standards have not been applied. In the event of partly applied harmonized standards, the technical documentation shall specify the parts which have been applied,
  5. results of design calculations made, examinations carried out, etc., and
  6. test reports.
  7. User & Installation manual
  8. Risk analysis & assessment report
  9. DOC (Declaration of Conformity)
  10. Warranty information

Related Quality System(Factory inspection)

  1. Quality manual
  2. Procedures related to product (Manufacturing, Inspection & Test method, CE Marking method, DOC Form & Issued, Document & records management procedure, etc)
  3. Procedures & Instruction list