Quality System for Medical Devices EN 46001 ISO 13485

Medical device manufacturers feel the need to install and certify a quality system in order to fulfill the requirements of the existing legal obligations, to ensure customer satisfaction, to improve internal efficiency, and to create a legal safeguard against lawsuits that can be filed. EN 46001 / ISO 13485 Management System include additional special conditions for medical device manufacturers, including ISO 9000 Quality Management System requirements. 

The companies which have to put CE Symbol on their products, are also required to obtain EN 46001 / ISO 13485 certification, when they have to use Annex 1 and Annex 2 modules. ISO 13485:2003 standard specifies the specific demands required by the quality system for the ones who work in the field of the medical devices.

ISO 13485:2003 is based on the ISO 9001:2000 standard and replaces the previous 1996 version of it. Its main objective is to provide the global harmonization of medical  devices to the quality rules. In other words, it is a standard which defines the specific requirements that the quality systems must provide for the manufacturers operating in the field of manufacturing, trade and distribution of medical devices. ISO 13485:2003, although is a special standard written for the Medical Devices, is organized in accordance with the infrastructure of the ISO 9001:2000. However, some specific issues are differentiated from the ISO 9001:2000 standard. Just as the ISO 9001, the new management system, while switching from the notion of the classical quality control to the process / process-based approach, forecasts to establish a direct link between the main objectives of the organization and the productivity.

The new standard can be used by all companies which cover the medical devices or the project, the production, the installation, and the procurement phases of the services related to those. The CEI EN ISO 13485 and 13488:2002 certificates issued on the basis of previous standards (ISO 13485:1996 and ISO 13488:1996) will be invalid at the end of 2006.


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