ZAO NeoCor plans, develops, documents, maintains and continuously improves its Quality Management System and operates in accordance with the requirements of GOST ISO 13485-2017. The Quality Management System is applicable to the design and production of biological prostheses for cardiovascular surgery.
The Quality Policy determines the ways the company achieves its goals:
- holding and strengthening company's position in the Russian market of cardiovascular surgery biological prostheses through the system managing interaction with surgeons and clinics, that use prostheses in cardiovascular surgery;
- marketing safe and effective medical devices through:
- design and development of new medical devices and improvement of existing products, obtaining comprehensive documented evidence of the declared parameters, efficiency and safety;
- risk-based approach application through the system of forecasting, registration and risk assessment of possible hazardous situations related to medical devices application and traceability of measures to reduce the risk level;
- maintaining the world-wide novelty level in cardiovascular prostheses design through cooperation with the Research Institute for Complex Issues of Cardiovascular Diseases, (Siberian Branch of Russian Academy of Sciences);
- educating and further training personnel to ensure consistency of the company's activities results and developing effective solutions for their improvement;
- enhancing employee culture with regard to application of Quality Management System principles through regular clarification of ISO 13485 requirements to employees in the context of the procedures, which employees are involved in.
Company managers undertake to meet the Quality Management System requirements and to maintain its efficiency and responsibility for the Quality Policy implementation.
NeoCor engages its entire personnel, from top managers to every employee, to continuously ensure products quality.