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ISO 13485 Standards for Quality Management System on Medical Devices
The certification of a quality management system, specifically for medical devices, to the ISO 13485 standard 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 standard or the ISO 13485 standards.
ISO 13485 -- Who is certified to these standards?
About ISO 13485
EN ISO 13485:2003
What is EN ISO 13485:2003 / AC 2007?
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 SÜD 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.
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