CE0120 (SGS) marking and EN ISO 13485. The FII’s quality management system is established to fulfil the requirements of standards NF EN ISO13485 2003, appendix II of European directive 93 / 42 / CE of 12/07/1993 modified by the European directive 2007 / 47 / CE of 05/09/2007, of appendix 1 of decree 95-292 of the 16/03/95 transcribing in French right the European directive 93 / 42 / CE, the book II 1st title of the part V of the public health code.
The FII quality management system articulates around the following axes:
- The technical know-how;
- The women and the men qualification;
- An organization centred on the satisfaction of needs customers and formalized through written procedures;
- A regular evaluation of the efficiency of this organization by internal audits;
- The improvement of our processes, our means, our manufacturing techniques.





Quality



