Technical File

PREPARATION OF THE TECHNICAL FILE

Manufacturers must organize, maintain and keep products technical documentation (Technical File). Documentation includes:

  • Project details

  • Manufacturing details

  • Operations details

  • Information on material compliance with the Directive

  • Product general description

  • Design/manufacturing drawings (diagrams, components, etc…)

  • Explanation notes

  • List of applied standard

RISK ANALYSIS

The technical documentation shall include an appropriate analysis and risk assessment against the essential requirements of the main Directives. This risk assessment is a key part of the technical file to demonstrate compliance with the essential requirements. The technical file must include an assessment of risk cases, even when the manufacturer ensures compliance through self-declaration. Inlab supports manufacturers in these delicate and not simple evaluations.

MANUALS AND LABELS

Together with the manufacturers and according to reference guidelines and regulations, InLab realizes:

  • user, maintenance and installation manuals

  • datasheet

  • product labels