The standard ISO 13485 is an international standard dedicated to the conception, fabrication and marketing of medical devices to ensure its quality and compliance to regulation. i2S provides, for many years now, a variety of vision devices for the medical domain. After gaining success and experience, i2S strongly invested in quality process in order to serve its clients better. The quality management system of i2S for the medical devices is certified ISO 13485 since 2015 by the Bureau Veritas’s organisation control. This certification covers the whole processes of the development conception, production and client service. This certification complements the ISO 9001 certification. It’s about an initiated process to respond to the needs of several medical projects in the course of this period like the programs for Biorad and bioMérieux, within each other.
ADVANTAGES of ISO 13485 FOR THE CLIENTS OF I2S
By dint of this certification, i2S has the power to expand its services for the clients working in the field of medical instrumentation. For many years now, i2S have been designing vision systems for major international OEMs and for new startups in this field alike. With this certification i2S:
- has the guarantee of a level of quality of its described product that is measured and consistent with time;
- continuously improves the process of conception and production of its products;
- manages the efficiency and controls in permanence the performances of the chain in its body;
- satisfies regulatory requirements and responds to the expectations of their clients by facilitating the approval of products;
- expands the access to the international markets because the standard ISO 13485 guarantees identified proper practices which are generalized and shared by the committers.
OBJECTVES OF ISO 13485
The main objective of ISO 13485 : normalize and standardize a way to guarantee the ability to trace in any point of the chain, to insure a level of quality and of proven and consistent reliability. Thus, it includes many particular requirements specific to medical devices, while referring to the essential requirements of ISO 9001.
CONCLUSION
This certification ISO 13485 of i2S demonstrates its capacity to regularly provide medical devices and associated services that meet the needs of its clients and to the regulatory requirements applicable to medical devices and associated services. This currently makes i2S a privileged partner in France for vision systems in the medical domain.