ISO 13845 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM

 ISO 13845 standard determines special requirements required for quality system that establishments,which want to prove ability of meeting legislation and customer terms,that is applicable for medical devices consistently, and to provide medical devices and relevant services, should comply with.

General purpose; This Standard identifies specific terms which quality management systems for producers in the manufacturing and trade of medical devices, should provide.  

ADVANTAGES OF  ISO 13845 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM;

» It provides global harmonization of medical devices to quality rules.

» It increases design, production and service quality of medical devices.

» It makes trade easier in this field.

» It increases trust for devices.

» Human health is protected depending on increasing in quality of devices.

» It increases competitive power of yours.

» Satisfaction of customer is ensured.