Quality at Firalis

quality firalis

QUALITY COMMITMENT AT FIRALIS SAS :

"Providing our clients with services and products of the highest quality standards."

At Firalis, continuous development is an objective for all our employees. We all are involved in this quality effort and participate actively in the constant improvement of our Quality Management System (QMS). The values driving the work performance and the quality system improvement are:

  • Responsibility : Set precise roles, functions and responsibilities. Ban conflict of interest.
  • Customer focus : Commitment to understanding customer inquiries using the best appropriate means of communication to ensure clarity and effectiveness of our response or our proposal.
  • Standardization : Performance of work in accordance to written procedures regularly monitored and updated.
  • Traceability : Full audit trail of responsibilities and actions, at all stages of a process.
  • Training : Managing, coaching, training and supporting employees; keeping up with the best practices and latest developments needed to carry out the work with the highest quality standards.

At Firalis, quality is assured through the implementation of the most relevant standards in our industry:

ISO 9001

ISO 9001:2008 sets out the criteria and the structure for the quality management system, ISO 9001:2008 is implemented by over one million companies and organizations in over 170 countries and is the worldwide reference for the management of quality systems. Click to see the certificate


ISO 17025

It is the most important standard for calibration and testing laboratories around the world. Laboratories accredited to this international standard have demonstrated their technical competence and ability to produce precise and accurate data over time and in line with the best practice of the art.

Firalis is one of the few CRO’s in Europe whose testing laboratory is accredited with a flexible scope (Portée B) which gives its laboratory the ability to implement under accreditation methods that it has developed or adapted (full scope on www.cofrac.fr ). Click to see the certificate


ISO 13485

ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, representing the requirements for 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.  Click to see the certificate


NF S96-900

NF S96-900 is a French standard which 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.


Good Clinical Laboratory Practice 
(GCLP)

In order to answer the needs of sponsors willing to outsource the analysis of biomarker samples to a GCLP supplier, Firalis has established processes compliant with GCLP guidelines (EMA/INS/GCP/532137/2010, Feb 2012; WHO Good Clinical Laboratory Practice - WHO 2009) . Click to see the full document

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