ISO 13485:2003 Quality Management System for Medical Diveces Industry


It is a very important guide for sterilization and hygiene, as products can show health, safety-safety and minimum requirements. Special requirements apply for sterile medical devices. It is also a guideline for the identification of risk groups of medical devices
This standard specifies the requirements of a quality management system that can be used by an organization to design, develop and supply services related to the design and development, production, installation and service of medical devices. It encompasses more comprehensive and specific quality system requirements than ISO 9001, which must be met by organizations seeking to demonstrate their ability to meet the customer and regulatory requirements applicable to medical devices in a consistent manner to provide medical devices and related services. It is based on the ISO 9001 standard. The main aim is a standard that defines the specific requirements that must be met by the quality systems for manufacturers operating in the field of manufacturing and trading of medical devices.
Benefits of the ISO 13485 standard
• ISO 13485 provides CE MARKING on medical devices,
• Adapts to Ministry of Health regulations,
• Adapts to the legislation of the European Union,
• Increase confidence in customers,
• Acceptance at national and international level.