ISO 13485 Quality Management System for Medical Devices

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 replaced current harmonized standards EN ISO 13485:2000 and EN ISO 13488:2000. The three-year transition period ended in July 2006. 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 13485:2003.

TÜV SÜD America is an SCC qualified ISO 13485 Registrar for the Canadian Medical Devices Regulations.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 or ISO 13485 standards.

ISO 13485 -- Who is certified to these standards?

• Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union.
  
  
• Companies, such as consulting shops, which design, manufacture, and assemble medical and in vitro diagnostic medical devices, and medical component manufacturers.
  
  
• Manufacturers of In Vitro Diagnostic Medical Devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.

Accreditations
TÜV Product Service is accredited by the ZLG in Bonn, Germany, as a Certification Body for quality management systems to ISO 13485. TÜV also holds accreditation with the Standards Council of Canada (SCC) and Health Canada for the Canadian Medical Devices Regulations. In addition, TÜV is a Notified Body for certification to all relevant EU Directives. With this complete service package, TÜV can assist medical companies in accessing markets nationally, in Europe, and globally.

About ISO 13485
The title of the ISO 13485 standards are as follows:

ISO 13485:2003
Medial Devices - Quality management systems - Requirements for regulatory purposes

EN ISO 13485:2003
Medial Devices - Quality management systems - Requirements for regulatory purposes adopted by the European Community as a European Norm (EN)

What is EN ISO 13485:2003 / AC 2007?
There was no change to ISO 13485:2003, the international standard for Medical devices — Quality management systems — Requirements for regulatory purposes.   The 2003 standard is the current revision.

In June 2007, CEN (European Committee for Standardization) published a corrigendum to the European standard, EN ISO 13485:2003 / AC 2007. This corrigendum only revises the Preface to the European standard as it applies to regulatory uses. The purpose of the change was to replace the old EN 46003. For example, it added references to Module E in several places. This links EN ISO 13485:2003 with Annex VI (final inspection) of the MDD. Therefore manufacturers can now be audited to the 13485 standard under Annex IV. However, there are no changes that directly affect manufacturers.

The latest “EN” standard must be used by Notified Bodies for approving medical devices. TÜV now indicates the following nomenclature on TÜV SÜD Product Service GmbH quality system certificates:  ‘EN ISO 13485:2003 / AC 2007.’ You may see some references to DIN EN ISO 13485:2007. This is the identical document. It is only the German adoption of the EN standard as its national standard.   

For additional service for medical devices, visit the medical section of our website.For more information, contact us.

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