EN ISO 13485

Standard EN ISO 13485 sets out requirements for a quality management system when an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet the requirements of users and prescribed requirements applicable to medical devices and related services.

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Medical Devices – Quality Management System is an internationally recognized standard for quality management systems in the medical device industry. The main goal of standard EN ISO13485 is to accelerate harmonization of legal requirements of the medical devices with the quality management system. It can be applied independently of other standards; it is largely based on the structure of standard ISO 9001, but includes some specific requirements for medical devices such as risk analysis, production of sterile products and traceability.

It sets out requirements for a quality management system where organization needs to demonstrate its ability to manufacture medical devices and related services to meet customer requirements and applicable legislation.

This standard is intended for use in organizations for design and development, manufacture, installation, service and sale of medical devices. It supports medical device manufacturers in designing quality management systems to establish and maintain the efficiency of their procedures. This ensures consistent design, development, production, installation and delivery of medical devices that are safe for their purpose.

Legal access of products to the market is important to all manufacturers of medical devices. EN ISO 13485 is often required by national legislation as part of the approval process for medical devices, e.g. EU Directive for Medical Devices 93/42/EEC, In Vitro Diagnostic Directive 98/79/EC, Medical Directive for Active Implants 90/385 /EEC.


By implementation and certification according to EN ISO 13485:

  • commitment to quality of medical devices is demonstrated;
  • there is improvement in overall performance of the process;
  • access to more markets are increased;
  • knowledge is acquired on how to review and improve processes throughout the organization;
  • efficiency is increased and costs are decreased;
  • it is proven that safer and more efficient medical devices are produced;
  • knowledge of regulatory requirements and customer expectations is proven;
  • profit increases;
  • productivity increases;
  • competitiveness increases;
  • customer satisfaction increases;
  • internal relations improves;
  • compliance with the requirements of the international market is proven;
  • international verification of good business practice is acquired;
  • a framework for continuous process improvement is created.