ISO 13485

Medical Devices-Quality Management System

ISO 13485 is a standard that stipulates the requirements for the quality management system of organizations providing design and development, production, installation and additional services of medical device. In addition, this standard can be applied to external organizations that provide services such as sterilization, calibration, and sales. It can provide the basis for a quality management system to organizations that provide medical devices and related services.

The importance of ISO 13485

Medical devices have a direct impact on human life and health, so they must ensure a higher level of stability than any other product. Therefore, the medical device industry must meet domestic regulatory systems, international standards and other requirements.

In order to meet the requirements of the EU Medical Device Directive, a quality system must be established, and some countries, such as Canada, require ISO 13485 certification for product sales.

With ISO 13485 system certification, A manufacturers who manufacture medical devices can demonstrate that their system meets the comprehensive requirements for quality management systems and the specific requirements for medical devices.

This standard helps following :

1. Management of all processes of the organization through ISO 13485 quality management system
2. Improvement of Work environment
3. Proactive quality management
4. Improving the awareness of the quality management system for all employees
5. Reduce cost and increase efficiency