Product Quality and Safety
We know that the quality of our diagnostic tests helps determine the treatment prescribed by a healthcare professional or the microbiological safety and time to market of a food or pharmaceutical product. We make every effort to guarantee the quality and safety of our products.
New companies, new subsidiaries, new products: the scope of our growth and the complexity of our business activity in a highly-regulated environment mean that, as a company, we have to move very quickly while complying with the highest standards of control everywhere in the world.
Our Quality Policy
Right from the start, bioMérieux’s Quality Policy is integrated into every aspect of our work. It guides our internal processes and drives positive business outcomes and efficiency.
We have developed a Global Quality Management System to oversee our processes and manage risk. This approach not only meets regulatory requirements, but it also decreases production cycle times, reduces product nonconformities and optimizes our supply chain. As a result, our products can be brought to market faster in order to satisfy the needs of our customers.
In line with regulatory requirements, our Quality Policy also depends on the participation of our sites and our subsidiaries throughout the world so that it is understood, applied and recognized by all employees.
Quality is not the job of the Quality Organization alone. It is a responsibility shared by all employees, affecting everybody from R&D to Sales, Manufacturing and Marketing, as well as the Support functions.
Performance indicators engage all employees in the achievement of quality objectives.
Continuous improvement initiatives are in place, and our teams worldwide share best practices.
The In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) went into force on May 26th, 2017. It replaces the In Vitro Diagnostic Medical Device Directive 98/79/CE (IVDD).
The date of application of IVDR is May 26, 2022 – meaning after that date, the new IVD devices placed on the market must be IVDR Compliant.
A recent amendment by the European Parliament allows some existing products to continue to be placed on the market in compliance with IVDD under certain conditions.