ANNEX XFull quality assurance

2.1.The manufacturer or his authorised representative shall lodge an application for assessment of his quality system to a notified body of his choice.

The application shall contain:

  • the name and address of the manufacturer and, where appropriate, his authorised representative,

  • the places of design, manufacture, inspection, testing and storage of the machinery,

  • the technical file described in Annex VII, Part A, for one model of each category of machinery referred to in Annex IV which he intends to manufacture,

  • the documentation on the quality system,

  • a written declaration that the application has not been submitted to another notified body.