Pristup rizicima u sistemu menadžmenta kvaliteta zasnovan na FMEA metodi

Risk management approach varies depending on activity and size of the organization, and can be achieved from many different aspects. Organization should recognize and properly address its risks and opportunities. Nowadays, business practice shows that this concept is important for successful business and operations of any organization. Furthermore, risk-based thinking is becoming an essen-tial principle of management system standards. Risk management tools and methods that organization should use depend on the adequate interpretation of these standards requirements. This paper presents an interpretation of the ISO 9001: 2015 requirements for the quality management systems, that are related to risk management, as well as some of the solutions based on the process approach combined with the use of FMEA method. This approach provides an excellent basis for enhancing the effectiveness of the quality management system, improving process results, and preventing negative effects.