The certification of a quality management system, specifically for medical devices, to ISO 9001/ISO 13485(EN 46001)proves advantageous, and in many cases essential, for medical companies which export their products to the global market.

In the European Union, the fulfilment 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 European harmonised medical device quality system standards are EN ISO 13485:2003 and EN ISO 13488:2000. These two standards will replace current harmonised standards EN 46001 and EN 46002 (transition period until March 2004), as published in the Official Journal (OJ) of the European Community on July 31, 2002.

When manufacturers are active in the world market, the focus on global or international standards (e.g., ISO) is not only advantageous - it may be stipulated by certain countries. For example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485 or ISO 13488 after January 2003. Existing licence holders have until November 2003 to demonstrate compliance.

In the U.S., the revised Quality System Regulation (21 CFR 820, Oct. 7, 1996) was based on the ISO 9001 and ISO 13485 quality system standards. US manufacturers in compliance with the FDA Quality System Regulations can assume that their quality system is close to meeting the requirements of the ISO 9001/ISO 13485 standards. Certification by TUV Product Service to ISO 9001/ ISO 13485 provides a third-party verification that your management system meets these requirements.

What does each standard mean?

ISO 9001 is a quality system standard applicable to many industries. ISO 13485/13488 are standards specific to medical device quality systems that supplement the ISO 9001 standard. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, trace ability, record retention, and regulatory actions, which are more critical for the medical device industry. ISO 13485/13488 are very similar to the European Standards EN 46001/46002, but do contain some additional requirements.

About ISO 13485 & ISO 13488

The title of the ISO 13485 and ISO 13488 standards are as follows:

• ISO 13485:1996: Quality systems - Medical devices - Particular requirements for the application of ISO 9001.
• ISO 13488:1996: Quality systems - Medical devices - Particular requirements for the application of ISO 9002.