Very early on, quality has become one of GenoScreen's priorities. This choice ensured that the company’s organizational structure and processes fully meet our customers’ and partners’ requirements. It also means that we comply integrally with all the local and international regulations applicable to GenoScreen’s services.
GenoScreen’s management has committed to guaranteeing:
- the quality and reliability of the services provided.
- the high-performance levels and reliability of the products sold.
- the accuracy of the results provided.
- long-term customer satisfaction.
- flexible services that meet the customer’s requirements.
- continuous improvement of the company’s organizational procedures.
This commitment to quality testifies to the values that structure our activities:
- Customer satisfaction.
- Continuous improvement of the quality of the company’s services and products.
- High performance through innovation.
ISO 13485: 2016 certification, Medical devices - Quality management systems - Requirements for regulatory purposes
GenoScreen is ISO 13485 certified for the "design, development, manufacture, marketing and distribution of in-vitro diagnostic kits. ». This certification completes the ISO9001 certification.
ISO 9001 certification : 2015 certification, Quality management system - Requirements
Authorization to handle highly pathogenic microorganisms and toxins (MOT)
GenoScreen has been authorized by the French drug safety agency to store, process and use highly pathogenic microorganisms and toxins (MOTs). This authorization guarantees that MOTs are handled safely and tracked fully.
Accreditation for highly pathogenic microorganisms and toxins (MOTs) by the ANSM (valid until 26/04/2023), in accordance with the French governmental decree #2010-736 dated June 30, 2010.
Illumina Propel certification
GCLP : Good Clinical laboratory Practice
Good Clinical Laboratory Practice (GCLP) is a well-established international quality system for laboratories that analyze clinical trial samples in accordance with Global Good Clinical Practice (GCP) regulations.
The requirements of this quality system guarantee patient's rights, preserve their confidentiality and ensure the reliability, quality and integrity of the work and results produced. The evaluation of our Metabiote® protocol: analysis of microbial communities by targeted metagenomics was performed in accordance with the EMA standard (28 February 2012) EMA / INS / GCP / 532137/2010