Quality

Quality at SAXOCON

Our quality management system is certified (certificate pending) according to the ISO 13485 international standard, audited by BSI International. Furthermore, we comply with the OECD Principles on Good Laboratory Practice. Our Quality Policy reflects our quality ambitions, and all employees receive training in our quality management system processes.

We provide top-tier toxicological and biological safety consultancy to companies operating in the medical devices, pharmaceuticals, food, cosmetics, and chemicals industries. Our certified quality management system and deep knowledge of state-of-the-art standards and regulations allow us to help our clients navigate a complex regulatory environment.

Our quality management system is designed to keep our focus on the client, ensuring high-quality deliveries through controlled procedures and a thorough understanding of client needs.

Quality by design is central to our approach to quality management and is integral to every aspect of our work. We recognise that quality does not just happen, nor is it a mere add-on, to be deployed as a final check at the end of a process. For us, good quality, like good design, is achieved through planning and is reflected in all the services developed by our multidisciplinary teams.

Client feedback is at the core of our quality assurance processes. We continually adapt and improve our services according to client needs, focusing on actual client requirements and not pure bureaucratic processes.

If you are interested in learning more about how our quality management system can support your business, please do not hesitate to reach out.

About ISO 13485


ISO 13485 is a QMS standard derived from the internationally recognised ISO 9000 quality management standard series. ISO 13485 is one of the most comprehensive quality standards, having strict requirements for quality control and documentation, from design to final product. ISO 13485 is the QMS standard accepted as the basis for the CE marking of medical devices under the European Medical Devices Regulation (MDR) and the US FDA.