Companies that trade medical devices are required by virtue of Ministerial Decision Ε3/833/1999 to have their Quality Management System certified. ISO 13485:2003 is based on the principles of ISO 9001:2008 and is specially designed for medical device companies. The aim of this Quality Management System (QMS) is to ensure:
- Compliance of the firm to the existing Legislation
- Development of a Quality Management System with documents, files and a manual
- Creation of a suitable environment and company operation ensured by specialised personnel
- Interaction with customers to ensure satisfaction
The benefits of the adoption of a Management System are the following:
- Cost reduction
- Higher customer satisfaction and improved reputation of the company in the market
- Increased productivity
- Increased satisfaction of employees
- Continuous improvement of processes
The aim of our company is to design a fully customised, simple and effective system that serves as a true “tool” for improvement.
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