Environmental and quality management system

Throughout the years the management system of SOFIC has obtained quality and environmental certifications, which are regularly renewed following successful audits.

ISO 9001 : quality management system.
ISO 13485 : quality management system for the design, development and manufacture of medical devices.
ISO 13485 with CMDCAS : quality management system for the design, development and manufacture of medical devices (certificate approved by the Canadian authorities).
ISO 14001 : environmental management system.
EC Certificate : products complying with the requirements of Council Directive 93/42/EEC, Annex II, Section 3.2.

ISO 9001 Certificate n°FM 32741 ISO 13485 Certificate n°80441 ISO 13485 with CDMDCAS Certificate n°FM 86084 ISO 14001 Certificate n°EMS 39265

Click on the icon to download copy of our certificates

Compliance with the repositories of SOFIC environmental and quality management system is assessed during audits led by the British Standards Institution (BSI), our Notified Body.
Each certification is assessed every six months, whereas 80 per cent of companies choose annual assessment.

Controls and tests

To ensure compliance of products with both regulatory and customers’ requirements, controls and tests are carried out at every stage of the production process :

controls upon receipt of raw materials,
individual control of cannulas,
assembling, labelling and packing controls,
release of sterile products by the Quality Manager upon receipt of biological indicators or sterility certificates.

Quality assurance

The deliveries of products come along with :

a declaration of conformity,
on request, biological indicator revelation results or sterility certificates for ETHYLENE OXIDE STERILIZATION.
on request, a GAMMAY RAY STERILIZATION CERTIFICATE.