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Latest update : 22.08.2016
LNE / G-MED: certification of company management systems
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Certification of Quality Management Systems

The reference standards used by companies in the medical device sector are:

  • NF EN ISO 13485
  • ISO 13485
  • ISO 9001

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).

> Rules for G-MED certification of quality management system

COFRAC accreditation
Certificates are issued in accordance with the international certification rules specified in standard ISO 17021 (COFRAC accreditation no. 4-0038).
Scope available on www.cofrac.fr

 

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

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