ISO 13485

It is occurred taking ISO9001 standard basic, is international standard which occurs special requirements .

They meet legal requirement as well as medical tool producers which want to have advantages in competition, have to demonstrate to adjust quality management system requirements.

Medical tool producers should meet legal requirements, provide customer satisfaction, to increase internal productivity and establishing of quality management and certification should be made to occur legal assurance against appeals.

EN 46001 / ISO 13485 quality management system includes requirements of ISO 9000 quality management system and addition special requirements.

Medical tool producers have to succeed obstacles of legal to enter Europe Community and Nothern American market. Some type of medical tool producers must establish quality management system suitable to ISO 13485 standard as legal in Canada and some Countries.

TO BE MONITORED WAY FOR ESTABLISHMENT OF 13485 QUALITY MANAGEMENT SYSTEM

1. Taking of standard training
2. Determining of strategy and work team
3. Occurring of quality Manuel
4. Occurring of supporting of procedures
5. Applying of system
6. Application for certification