International ISO 13485:2003 standard specifies requirements for a quality management system, which are to be met by organizations specializing in development, design, manufacturing and installation of medical devices and associated services. 

ISO 13485:2003 is based on the principles of ISO 9001:2008 and, thus, has a similar structure. However, it features additional requirements for medical devices and aims to promote inclusion of harmonized standards for medical devices into quality management systems. The requirements and standards apply to all organizations that are present on the market of medical devices and associated services. 

Requirements to quality management system stipulated by this standard are supplementary to technical specification, which means that adoption of ISO 13485:2003 is voluntary. 

•All business processes are optimized according to the quality management system, which focuses on development, design, manufacturing and use of medical devices and associated services;

•Enhanced company image;

•Enhanced company competitiveness;

•Better investment opportunities;

•Increased profits;

•Expanded product market.

•Documentation required quality management system development;

•Analysis of the existing documentation;

•Audit of the company;

•Employees training;

•Certification of the quality management system according to ISO 13485 standard.