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Quality Management System

Quality Management System

The international experience and national practice show that the progress and competitive capability of the enterprises are directly associated with the functioning of the Quality Management System. 
 
The international experience of the quality management in the area of medical product manufacturing is concentrated in DSTU ISO 13485 (ISO 13485) Standard to the fullest extent possible.(ISO 13485). Quality Management System
The Quality Management System effectively functioning at the enterprise and complying with the International and National Requirements is a tool for control and permanent improvement of the product quality and enterprise activity indices. The very system itself assures competitive advantages thanks to the focusing of the Company’s activity on the intention to satisfy and exceed the Customer requirements forming a reliable and impressive image of the enterprise.
 
The Quality Management System certified according to DSTU ISO 13485 (ISO 13485) becomes an essential prerequisite when entering into the Contracts with the Customers as a guarantee of the stable quality and safety of the Manufacturer’s production as well as the compliance of production with the National Technical Regulations and the International Directives.
 
This is precisely why, the Quality Management System is certified at the ABM Technology Medical Product Plant according to the International Standard ISO 13485:2016 by IMQS.p.A., Italian Certification Body. Besides, the Quality Management System is certified according to Ukrainian Standards DSTU ISO 9001:2015 and DSTU ISO 13485:2015. The Quality Management System in ABM Technology LLCcovers all processes from the manufacturing planning to product shipping to the Customer making it possible to assure stable quality at the European level. The high quality of products manufactured by ABM Technology LLC is confirmed by the Certificate of Conformance to the Technical Regulations on Medical Products approved by Decree of the Cabinet of Ministers of Ukraine No. 753.
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Our products sum up a long-term experience of the employees in the area of development of medical products for dental implantology and osteosynthesis being realized in the new inventions. Currently, the ABM Technology Medical Product Plant has already received patents for useful model of dental implant as well as the industrial prototypes of dental implants and suprastructures.
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