سيستم مديريت کيفيت ايزو ۱۳۴۸۵ برای سازندگان تجهيزات پزشکی

The certification of a quality management system, specifically for medical devices, to ISO 9001 and 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 published July 24, 2003. This standard will replace current harmonized standards EN ISO 13485:2000 and EN ISO 13488:2000 with a three year transition period ending 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 or ISO 13488. Existing license holders must demonstrate compliance after November 1, 2003 with their license renewal application. Canada has also adopted the new ISO 13485:2003 standard and will require all ISO 13485 certificate holders to transition to the new standard by March 14, 2006. TÜV America is an SCC qualified ISO 13485 Registrar for the Canadian Medical Devices Regulations. Click here to view SCC's Transition Policy for ISO 13485:2003.

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.

What does each standard mean?
ISO 9001 is a generic quality system standard applicable to many industries. ISO 13485:1996 and ISO 13488:1996 are standards specific to medical device quality systems that supplement the ISO 9001:1994 and 9002:1994 standards. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are critical for the medical device industry.

On July 15, 2003, a new ISO 13485:2003 standard titled, ISO 13485:2003 Medical Devices - Quality management systems - Requirements for regulatory purposes, was published and began a three-year transition period. The ISO 13485:2003 is a stand alone standard. During the transition period, manufacturers may seek compliance to either the 1996 or 2003 version of the standard.

The transition of ISO 9001:1994 to ISO 9001:2000, ending December 15, 2003, does not affect the validity of the ISO 13485:1996 standard because it is not linked to the expiration date of ISO 9001:1994. As long as the ISO 9001:1994 standard is referenced in a valid standard (ISO 13485) it is the basis for these standards, independent from being expired or not.

ISO 9001 / 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 and 13488. 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.

Overall, TÜV is the leading ISO 13485 Registrar in North America.*

About ISO 13485 & ISO 13488
The title of the ISO 13485 and ISO 13488 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)

ISO 13485:1996
Quality systems - Medical devices - Particular requirements for the application of ISO 9001:1994

ISO 13488:1996
Quality systems - Medical devices - Particular requirements for the application of ISO 9002:1994

The ISO standards are copyrighted material and must be purchased from an approved vendor. To purchase these documents, visit our TÜV Store.

What is the difference between ISO 13485 and ISO 13488?

  • ISO 9001:1994 and ISO 13485:1996 are applicable to manufacturers and service providers that perform their own design activities.

  • ISO 9002:1994 and ISO 13488:1996 are for manufacturers and service providers without design activities.

  • ISO 13485:2003 includes provisions for both manufacturers and service providers with/without design activities.

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