The quality management system for enterprise-producers of medical devices (standards ISO 13485-2004 (ISO 13485:2003))

The system of ISO 9001 are the requirements for companies of various industries, including manufacturing enterprises for medical devices. Traditionally, in the scope and standard of international level (ISO 13485:2003), and the Russian standard (GOST R ISO 13485-2004 - "medical devices. Quality Management System. System Requirements for regulatory purposes"). Requirements and standards set forth in these documents apply to those enterprises the healthcare industry, whose activity consists in the supply, development, maintenance, assembly and manufacture of various medical products.

The purpose of these standards - the introduction of effective quality management systems in enterprises which are engaged in supplying and manufacturing of diagnostic devices and instruments, medical and anesthetic techniques, etc. The updated or newly established Quality Management System for the medical industry companies will be capable of guaranteeing high quality products and to prevent all possible hazards that exist in the manufacture of medical devices and products.

Those companies that have certified quality management system in accordance with the requirements of ISO 13485:2003 or ISO 13485-2004, immediately acquire significant competitive advantages, namely:

•     Simplification of procedures for certification and licensing of finished products;
•     Simplification for enterprise in the international market;
•     Detailed the conditions of export of medical products;
•     Increased chance to win various tenders and competitions;
•     Creating a positive company image in the eyes of its micro-and macro-(customers, partners, shareholders, government, investors, etc.);
•     Formation of the business community a reliable partner of the image;
•     Increase the investment attractiveness of the enterprise.

Documentary confirmation of the passage of an enterprise quality management system certification is done by issuing a certificate. This document is valid for three years, but it must reaffirm each year. Confirmation is done by the inspection control. The presence of an enterprise certification allows him to demonstrate all the interested parties officially certified by the quality of their products (medical devices) and all works and services included in the area of ​​quality management system certification. May only issue a certificate of the accredited body.

The company "Euro ISO" is an accredited certification centers providing consulting market in the whole range of work for the passage of the enterprises in the certification process system of voluntary certification of integrated management systems "Alliance Certification." Specialists of our company will give you all necessary information on the contents of the stages of certification and the cost of the work.