ISO13485:2003 Medical Sector Quality Management Standard

It is an international standard established by basing on ISO 9001:2000 standard, and contains specific conditions for medical devices. This standard covers the quality management system requirements for an organization that must prove its ability to provide medical devices and consistently meet customer requirements and regulatory requirements applicable to medical device related services. The main purpose of this standard is to facilitate the medical device legislation requirements harmonized for the quality management systems.

This Standard was established to configure manufacturers, distributors, importers and exporters, and the organizations that provide these services. This system complies with EU Medical Devices Directive and is implemented along with the CE brand.

HISTORY OF ISO 13485 SERIES

- ISO 13485:2003 published on 15.07.2003

- EN ISO 13485:2003 published on 24.07.2003

- EN ISO 13485:2003 harmonized on 02.04.2004

- However, the new EN ISO 13485:2003 only supersedes EN ISO 13485:2000 and ISO 13488:2000, and the transition period is three years.

- EN 46003 will remain in effect in conjunction with EN ISO 9003.

- The European foreword of EN ISO 13485:2003 says that EN 46003 should be immediately configured for the process oriented insertion.