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The present article has focused on risk-based thinking in the production process according to the updated ISO/FDIS 9001/2015 Quality Management System – Requirements. One of the crucial changes of this update is incorporation of the risk-based thinking into quality management system of organizations. This article deals with this current issue of correct understanding of the actions to address risks in the processes influencing the customers. On the basis of the new updated standard and case studies focused on application of the method of the FMEA Process (Failure Mode and Effects Analysis) as well as the method of Quality Assurance Matrix in the production process, suitability of using these methods for risk assessment in the production process has been assessed. The result is utilisation of these methods of FMEA and QAM for identification, analysis and risk assessment in the production process taking into consideration the requirements of the respective standard.

Risk-based thinking in the production process using the methods of Quality Assurance Matrix and the FMEA Process