Firalis Molecular Precision

Our Quality Management System

Complying to quality standards is central to our work.
We uphold the highest standards in all of our operations because we understand the importance of quality in scientific research fields.

Several of our activities are conducted using our parent company’s quality management system.

It has been certified/accredited for some general and technical standards for years.

ISO 9001:2015

Certificate N° 2014/58992.7

It sets out the criteria for a quality management system. This standard is based on some quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement.

Using ISO 9001 helps ensure that customers are provided with good-quality services.

ISO 14001:2015

Certificate N° 2022/100533.1

It specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. Consistent with the organization’s environmental policy, the intended outcomes of an environmental management system include enhancement of environmental performance, fulfilment of compliance obligations and achievement of environmental objectives.

ISO 13485:2016

Certificate n° 2014/58993.6

It specifies requirements for a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

This includes design and development, production, storage and distribution, installation or servicing of a medical device as design and development or provision of associated activities (e.g., technical support). 

ISO 20387:2018

Certificate N°2024/108791.1

It’s an international standard that specifies requirements for the competence, impartiality, and consistent operation of biobanks involved in the collection, processing, storage, and distribution of biological materials and associated data for research and development purposes.

It provides guidelines to ensure the quality, reliability, and traceability of biological samples, thereby fostering confidence in research outcomes and facilitating collaboration among biobanks and researchers worldwide.

Compliance with ISO 20387 signifies adherence to best practices in biobanking, ultimately enhancing the credibility and trustworthiness of biobank services and the integrity of scientific research.

CAP Laboratory Accreditation

CAP Number : 9211908 / AU-ID : 2161952

The CAP Accreditation is a program offered by the College of American Pathologists which assesses the quality and accuracy of medical laboratories and ensures they meet rigorous standards for testing and diagnosis. 

We are the first bioanalytical laboratory in France to achieve CAP Accreditation which underscores our dedication to upholding the highest standards of quality, accuracy, and reliability in laboratory services.

We are committed to delivering high quality in every aspect of our bioanalytical services, aimed at advancing precision medicine in every therapeutic area.