The industrial competition with which we are confronted forces us to evolve constantly. To be competitive is a requirement and to satisfy all needs of our costumers is a necessity.
The future of our company depends on the four fundamental factors, which are the prices, the deadlines, the innovations and the quality. The quality is the essential factor that will enable us to durably affirm our reputation to our costumers and to conquer new markets.
Moreover, the European manufacturers of medical devices are subjected to many regulations that must be respected to be authorized by competent authorities to manufacture and market their products.
It is for these various reasons that we have decided to set up a program of Quality Management to satisfy the customer requirements according to regulations of ISO 9001:2000 and ISO 13485 :2003 for the European Union and CFR 820 for medical devices concerning the United States.
Everyone see all the necessary efforts which the installation of such a system requires for our company and this is only possible through a collective Quality management. An overall engagement is an essential condition for our success. We convey our staff to the necessity to satisfy the requirements of our customers and of the regulations.
The Quality manual formalizes the Quality system of our company as well as the provisions taken to ensure our customers Quality of our products and services. It is a document that must be continuously improved to be efficient and it is an overall responsibility to take part in this.
Within the Head of the company, Nicole Levy, Quality Manager, has the essential role to define and maintain the Quality System, by drawing up defined quality’s goals. She also ensures an overall good understanding and application of all the arrangements taken. All the actions taken by the Quality Manager are assured by our support.
Our future efficiency depends on the effort that we will all make to prepare, respect and especially to improve the Quality system of our company. To ensure that this policy in understood by everyone, effectively implemented and maintained on all levels of our company, we regularly carry out management reviews and internal audits.
We undertake ourselves to put the necessary means for the installations of the dispositions retained by the Quality Manager.
- Administrative and Commercial Management
- Fabienne Levy
- Technical Management
- Fabienne Levy Nicole Levy