Certification of Quality Management Systems
Quality Management Systems (QMS) may be certified in a statutory or voluntary context. The reference standards used by companies in the medical device sector are:
- NF EN ISO 13485:2004
- ISO 13485:2003
- ISO 9001:2000
At a statutory level, compliance with harmonized European standard EN ISO 13485 guarantees conformity to all statutory requirements covering quality assurance systems (complete, production, product).
Certificates are issued in accordance with the international certification rules specified in standard EN 45012 or the ISO 62 guidelines (COFRAC accreditation no. 4-0038).
Certification of Environmental Management Systems
Environmental management systems (EMS) are certified in a voluntary context. The reference standard used is ISO 14001.
On a commercial level, conformity certification of an EMS is a major asset for obtaining access to the international market, submitting tenders and subcontracting.
For information on the LNE/G-MED certification process, see the section Obtaining certification