The certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market.
In the European Union, the fulfillment of EU Directives (e.g., Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU directive requirements is the establishment and independent assessment of the quality system.
The current European medical device quality system standard is EN ISO 13485:2003, which will replace current harmonized standards EN ISO 13485:2000 and EN ISO 13488:2000 with a three year transition period ending July 2006.
ISO 13485:2003 provides a harmonized set of quality management system requirements for medical device manufacturers. Based on a process approach to quality management, it focuses on what the manufacturer does to provide safe and effective medical devices.
Your ISO 13485 certificate can help you enter almost any market in the world. It is currently recognized in most major markets (including the EU, US, Canada, Japan, and Taiwan), and will very likely become widely adopted by other regulatory authorities around the world. You can get it all with one single audit!
While it is based on ISO 9001:2000, ISO 13485 does not include the customer satisfaction and continual improvement clauses - so an organization certified to ISO 13485 does not automatically meet the requirements of ISO 9001 unless it is assessed against that standard separately. Compliance with ISO 13485 also does not equate compliance with regulatory requirements, although in many cases it can facilitate the audit process for those requirements. |
