Preparation Of Technical Files

A technical file provides a technical justification for your claim to conformity on which your CE marking is based. CCQS can help you compile a Technical File that will meet the requirements of any client or enforcement officer. The process of compiling a Technical File also provides a structured way of assessing conformity. CCQShas a great deal of experience in making risk assessments and compiling checklists against harmonised standards, Essential Health and Safety Requirements.

Technical File

A technical file is the Technical Justification for the claim to CE conformity. Different Directives have different requirements for Technical File content, but fundamental content is:-

  • A technical description of the equipment including mechanical drawings and schematics.
  • Copies of user instructions.
  • Test reports
  • Checklists against essential requirements of Directives
  • Checklists against requirements of standards.

It is not mandatory for a manufacturer to hold a Technical File at all times, but without actually going through the process required to compile a Technical File, it is hard to decide whether your equipment is actually in conformity.

The only persons who have a right to demand a copy of a Technical File are enforcement authorities such as HSE inspectors or customs officials. They may request a copy of the Technical File fi they have any doubts about the conformity of some equipment.

Purchasers of equipment have no legal right to demand that a copy of a technical file is provided to them, but many larger purchasers have started to include a contractual requirement that a copy of a Technical File is provided to them as an assurance.

There is no mandatory format for a Technical File, but CCQS has a Technical File folder template which has been found to meet the requirements of most projects. It is available for free download here.

 


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