At bioMérieux, we should never forget that every day, somewhere in the world, a clinician makes a decision for a treatment, or a food product is released for consumption, based on the quality of a test we are providing. Our tests must provide an optimum level of performance because our customers are themselves responsible for the quality of the test results they provide to those who depend on them. This is why we consider Quality to be everybody’s responsibility.
New companies, new subsidiaries, new products: the scope of our growth and the complexity of our actions mean that as a company, we have to move very quickly while maintaining the highest standards of control in an extremely regulated environment. We have to provide one set of standards and one set of processes throughout the world.
bioMérieux’s Quality Policy guides our internal processes and drives good business outcomes and efficiencies. In line with Regulatory requirements, it also draws upon input from the company’s sites and subsidiaries worldwide to ensure that the policy is understood and embraced by all employees.
It helps us to:
- enhance public health worldwide
- understand and meet our customers’ needs
- share goals and responsibilities with all employees
- improve our processes and performances
Quality by design
We have our minds set on doing better every day and when it comes to our Quality Policy, we adopt a holistic approach. Our goal is Quality by design in everything we do: our aim is not to create Quality by checking, but Quality right from the start by integrating it into every aspect of our work.
We have a Global Quality Management System to control our processes and manage risk. This approach helps assure fulfilment of regulatory requirements. It leads to decreased production cycle times, reduced product nonconformities and an optimized supply chain. Products can thus be launched rapidly on the market to satisfy the needs of our customers.
Quality is everybody’s responsibility
Quality is not the job of the Quality Organization only: it is a shared responsibility by all employees, affecting everybody from R&D and Manufacturing to Sales and Marketing, as well as Support functions. Performance indicators engage all employees in the achievement of quality objectives. Continuous improvement initiatives are in place, and best practices are exchanged among the company’s teams worldwide.
Recognizing the essential role that diagnostics plays in public health, it is our responsibility to help customers do their job by understanding their needs and making sure that we meet them. Our Quality Policy is key to achieving this.
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International Standards
We adhere to strict international quality regulations and standards. Careful attention to quality at R&D and production sites is essential to satisfying the requirements of regulatory agencies such as the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), the U.S. Food & Drug Administration (FDA) and other agencies such as LNE/G-MED, DNV, LRQA, BVQI and TUV.
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Quality Policy
“The shared goal and responsibility of each bioMérieux employee is to understand customers’ needs and, by continuously improving our processes and performance, to meet or exceed their expectations, with high quality, innovative products and services that enhance public health worldwide.”
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