|
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.
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 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)
The
ISO standards are copyrighted material and must be purchased from an approved
vendor. To purchase these documents, visit our
TÜV Store.
Other Standards
ISO 9001
ISO 9000, originally published in 1987 by the International Organization
for Standardization, is a generic quality systems standard that specifies,
in very broad terms, the necessary components of a quality management
system. Rather than being specific to any one industry, ISO 9001 details
the basic requirements of the quality function for all industries. ISO
9001 provides the tools to grow a better business through continuous
improvement and refined processes.
ISO 14001
ISO 14001 is an internationally recognized environmental management system
conformance standard. Very similar in structure to the ISO 9000 quality
management system standard, ISO 14001 outlines' key requirements to which
companies should comply in order to operate in an environmentally responsible
manner. Utilizing ISO 14001, companies can help merge environmental programs
into one coherent system to efficiently manage all environmental activities.
For more information,
contact us.
|
