Quality & Accreditations

For Biofortis, quality is perceived as an daily improvement  tool. Quality is also a collaborative approach: trust and quality are part of a global objective. In order to answer it's customer needs, Biofortis is flexible and reactive. 

The implementation of our quality results from:
- Our scientific rigor and level of accreditation

- The desire to meet the needs of our customers

 

A CRO and a certified laboratory

To confirm its commitment to quality, Biofortis is certified ISO 9001.

The quality approach is extended to all Biofortis activities, namely:
- Setting up, implementing, following up and interpretating clinical studies, mainly in the field of human nutrition (turn key clinical studies).

- Specialized analyses in the field of metabolic disorders (in particular lipid disorders). The certification ISO 9001 guarantees the quality level of services.

 

Authorized place of biomedical research

Biofortis has been authorized by French health autorities to realize biomedical research in the field of nutrition, on healthy volunteers (adults and children).


Quality controls

Biofortis ensures the accuracy of laboratory tests by participating in a program of external quality control and inter-laboratory tests:

Digital PT is a program of external quality controls for the central laboratory. As such, the Biofortis central laboratory is on the list of laboratories certified by the international clinical CRMLN (Cholesterol Reference Method Laboratory Network).
- The Biofortis central laboratory also participates in external quality control programs for biological and biochemical analysis with the CAP (College of American Pathologists)
- The Biofortis laboratory participates in inter-laboratory tests with BIPEA (International Bureau for analytical studies) for analysis of GMOs, with the FAPAS
- (Food Analysis Performance Assessment Scheme) for GMOs and allergens analysis and the DLA for the analysis of allergens.
 - GMO testing services are covered by COFRAC accreditation under the ISO17025 rules and following the specific norms:
    - NF EN ISO 24276 “General requirements and definitions”
    - NF EN ISO 21571 “Nucleic acids extraction”
    - NF EN ISO 21569 “Qualitative method”
    - NF EN ISO 21570 “Quantitative method”
(Reference 1-2317, see www.cofrac.fr for detailed description of the scope of accreditation)

Biofortis is committed to providing a suitable offer in accordance with customer expectations by maintaining optimal conditions. Our values of integrity are our roots and determine the scientific rigor of implementing, monitoring and reporting by all our employees.