Quality & certifications - High standards and excellence for the benefit of our customers
At GenoScreen, quality is a fundamental requirement. Quality has always been at the core of everything we do, guided by the highest industry standards. Our genomics, molecular microbiology, and bioinformatics services and products are supported by a reliable quality management system recognized nationally and internationally.
Ensuring reliability, compliance, and customer satisfaction through certified quality
We are committed to providing services and products that are:
High-quality, reliable, and efficient
Fully compliant with regulations
Tailored to the needs of clinical laboratories, research centers, industry players, and public institutions
Our quality approach is based on:
Continuai improvement of our internai processes
Close collaboration with our clients
Technological innovation to enhance performance
Adaptability to regulatory and scientific developments
Our quality objectives for reliable and compliant services
Our quality commitments are clear and tangible:
Delivering innovative and reliable services
Continually improving our processes
Ensuring lasting customer satisfaction
Complying with national and international standards
Tailoring our services to the specific needs of each client
Our quality certifications and standards
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ISO 13485:2016 Certification – Quality Management Systems for Medical Devices
Certification date: October 31, 2025
Expiration date: November 7, 2027
GenoScreen holds ISO 13485:2016 certification for the design, development, manufacture, marketing, and distribution of in vitro diagnostic kits.
This certification guarantees the safety, quality, and traceability of our medical devices, meeting international regulatory standards (Europe, FDA, and beyond).
ISO 9001:2015 Certification – Quality management system for all products and services
Certification date: October 31, 2025
Expiration date: November 7, 2027
Our ISO 9001:2015 certification confirms the quality of all our activities: • Design and development of genomic solutions
• Sequencing and analysis services
• Scientific training and expertise
It applies across all our service divisions and ensures controlled, fully documented processes.
GenoScreen applies Good Clinical Laboratory Practice (GCLP) standards to ensure rigorous and compliant analysis of samples in clinical trials.
This ensures:
• Compliance with GCLP standards
• The quality, reliability, and integrity of clinical data produced
• Protection of patient confidentiality and rights
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Compliance with national and international regulations
Protective measures against plant pests (EU Regulation 2016/2031, 26 October 2016)
Our authorization, formalized by a prefectural decree, covers the receipt and handling of soil samples from non-EU countries in accordance with the derogatory measures of EU Regulation 2019/829. The authorization was issued by the Regional Directorate for Food, Agriculture and Forestry (DRAAF), Plant Health Service.
Directive 2009/41/EC and Decree No. 2011-1177 on the contained use of genetically modified organisms
Expiration date: December 18, 2029
Our authorization covers the possession and use of Class 1 genetically modified organisms (GMOs) for research, development, or educational purposes, in accordance with Article L.532-3 of the Environmental Code.
Authorization for highly pathogenic microorganisms and toxins
Expiration date: December 18, 2029
GenoScreen is authorized by the French National Agency for Medicines and Health Products Safety (ANSM) for the possession, handling, and use of highly pathogenic microorganisms and toxins (HPT). This authorization ensures the safe management of HPTs and full traceability of their handling and transfer.
HPT Accreditation (Highly Pathogenic Microorganisms and Toxins) from ANSM (valid until 21/03/2030): Authorization for the possession, acquisition, handling, and use of HPTs in accordance with Decree No. 2010-736 of 30 June 2010 on microorganisms and toxins (list defined in Article L5139-1 of the French Public Health Code
, as specified by the Order of April 26, 2023).
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Further recognitions and certifications
Crédit Impôt Recherche
GenoScreen is CIR program-accredited for the 2025–2029 period, reflecting the high quality of its research and development (R&D) activities in genomics and bioinformatics.
Oxford Nanopore Technologies Certified Service Provider
We are a certified service center for Oxford Nanopore (GridION) long-read sequencing technology, ensuring:
• High-quality analyses
• Advanced technical expertise
• Personalized support for your long-read sequencing projects
Frequently Asked Questions
What quality certifications does GenoScreen hold?
GenoScreen is certified ISO 9001 :2015 for all its genomic, bioinformatics, and molecular microbiology activities, and ISO 13485:2016 for the design and production of in vitro diagnostic kits. The company also follows GCLP principles for activities related to clinical trials.
Why is ISO 13485 certification important?
ISO 13485 certification ensures that the medical devices produced by GenoScreen meet strict standards of quality, safety, and regulatory compliance. lt is essential for both European and international markets.
Is GenoScreen authorized to handle pathogenic microorganisms?
Yes, GenoScreen has a MOT authorization issued by the ANSM, allowing it to hold, use, and exchange highly pathogenic microorganisms and toxins under strictly controlled conditions.
Are GenoScreen's services suitable for clinical trials?
Yes, GenoScreen follows Good Clinical Laboratory Practices (GCLP) to ensure the quality, integrity, and traceability of analyses performed in clinical trials.
