at Firalis, all services are performed under certifications of the
HIGHEST INDUSTRY STANDARDS
ISO 9001:2015
Worldwide reference standard for Quality Systems Management
ISO 13485:2016
Quality Management System for the Design & Manufacture of Medical Devices
NF S96-900
French standard for collection, preserving and making available biological resources
ISO 14001:2015
Development, Production and Sales of IVD tests, Storage & Analysis of biological and environmental samples
click on the boxes above to view the associated Quality certificate
QUALITY VALUES of Firalis :
> Responsibility : We set precise roles and functions to prevent and ban conflict of interest.
> Qualification : We train and coach our employees to develop competences and keep up with the best practices.
> Customer Focus : We challenge our customers for utmost clarity and ensure strict confidentiality of all client data.
> Standardization : We perform all work according to written procedures regularly monitored and updated.
> Traceability : We keep a full audit trail of responsibilities and actions at all stages of service/production processes.
QUALITY STANDARDS of Firalis :
> ISO 9001
ISO 9001:2015 sets out the criteria and the structure of a quality management system and is implemented by over a million companies and organizations in over 170 countries and is the worldwide reference for the management of quality systems.
View Firalis' certificate here
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> ISO 13485
ISO 13485 sets all requirements of a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485 is harmonized with requirements set by the European medical device directives 93/42/EEC and 98/79/EC.
Subject certificate is valid and covers the following activities :
-Development, Manufacturing and Placing on the Market of Immuno-assays and Nucleic Acid Detection in Vitro Diagnostic Devices in the Frame of Cardiac, Neurodegeneratives, Immuno-inflammatory and Infectious Diseases.
-Development, Production and Sales of Immuno-assays and Nucleic Acid Detection in Vitro Diagnostic Devices for Research Purposes
-Development, production and sales of intermediate and derived products, antibodies and proteins for research purposes
View Firalis' certificate here
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> ISO 14001 : 2015
ISO 14001 : 2015 sets all requirements of a comprehensive quality management system for the development, production and sales of in vitro diagnistic tests (immuno-assays and nucleic acid detection tests) as well as the storage and analysis of biological and environemental samples.
View Firalis' certificate here
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> NF S96-900
NF S96-900 is a French standard that applies to structures that collect, preserve and make available biological resources in accordance with the legislation in force. This norm was developed following an approach consistent with existing documents and in particular, the standard NF EN ISO 9001 and the guidelines of the OECD. It specifies the requirements for a comprehensive quality management system for the collection, transport, storage of biological resources. NF S96-900 not only helps ensure the quality of the samples to users, but also gives patients the assurance that the samples they agreed to donate for research are used in accordance with their will and their privacy.
PS: NF S96-900 will soon be replaced by the ISO 20387 certification (implementation ongoing)
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> Compliance for Good Clinical Laboratory Practice (GCLP)
To answer sponsors' needs to outsource analysis of biomarker samples (to a GCLP supplier), Firalis established processes compliant with the GCLP guidelines (EMA/INS/GCP/532137/2010, Feb 2012; WHO Good Clinical Laboratory Practice, 2009).
For more information, contact Firalis' Quality Team !