Our Quality Management System
We uphold and maintain the highest standards in all of our operations to provide accurate, precise and reliable results with our Bioanalytical Testing services.
We prioritize quality in every aspect of our bioanalytical services.
At Firalis Molecular Precision, we are quality-focused and we pay close attention to our clients’ research needs. We make sure to provide the expected results, meeting pressing turnaround times and respecting quality requirements.
Our commitment to quality, scientific rigor, and cutting-edge technology makes us a trusted and reliable partner for our sponsors.
Through rigorous method validation and strict adherence to accreditation and certification standards, we guarantee that our facilities, equipment, laboratory experts, and practices meet the highest benchmarks for quality.
Our robust Quality Management System (QMS) undergoes ongoing compliance and continuous improvement, thereby enhancing our operational efficiency and service delivery.
Learn more about Firalis Molecular Precision's commitment to quality
The standards we adhere to
ISO 9001:2015
Certificate N° 2014/58992.9
ISO 9001 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.
Adhering to ISO 9001 ensures that our sponsors are provided with the highest quality services to make informed decisions and advance their research projects.
ISO 14001:2015
Certificate N° 2022/100533.3
ISO 14001 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance.
Consistent with Firalis Molecular Precision’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° 2014/58993.7
ISO 13485 is an internationally recognized standard for quality management systems specific to the medical device industry. It demonstrates our ability to develop, manufacture, and place in the market immuno-assays and nucleic acid detection in vitro diagnostic devices. The standard covers diagnostics for cardiac, neurodegenerative, immuno-inflammatory, and infectious diseases.
By adhering to ISO 13485, we guarantee quality, reliability, and regulatory compliance across all stages of product development and delivery.
ISO 20387:2018
Certificate N°2024/108791.1
ISO 20387 is 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 R&D purposes. It provides guidelines to ensure the quality, reliability, and traceability of biological samples.
Compliance with ISO 20387 implies our adherence to the best practices in biobanking, to store and manage our sponsors’ biological samples efficiently in the strictest conditions.
CAP Laboratory Accreditation
CAP Number : 9211908 / AU-ID : 2161952
The CAP Accreditation is a program offered by the College of American Pathologists assessesing the quality and accuracy of medical laboratories and ensuring that they meet rigorous standards for testing and diagnosis.
We are the first bioanalytical laboratory in France to achieve CAP Accreditation which highlights our dedication to upholding the highest standards of quality, accuracy, and reliability in our bioanalytical laboratory services, enabling informed decision-making and better patient care.
French Research Tax Credit (CIR) Accreditation
A tax incentive program in France that is designed to encourage research and development (R&D) activities by companies.
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP ensures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible and accurate.
Our commitment to GCP principles provides our clients with the confidence and support needed for successful clinical research outcomes. Our team undergoes regular GCP training to stay informed of the latest regulations and industry best practices.
