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
ISO 14001:2015
Development, Production and Sales of IVD tests, Storage & Analysis of biological and environmental samples
GCLP
Compliance for Good Clinical Laboratory Practice
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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> 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 !