In order to obtain approval of its quality system, the manufacturer must submit an application for assessment to a body, which must include :
1° The name and address of the manufacturer ;
2° the places of design, manufacture, inspection, testing and storage ;
3° The technical file provided for in Article R. 4313-6 for one model of each machine listed in Article R. 4313-78;
4° Documentation on the quality system;
5° A written declaration specifying that the same application has not been submitted to another notified body.