Research Question (RQ): Does the introduction of the FMEA method in the organization reduce the number of customer complaints? Are the results of the introduction of DFMEA and PFMEA functions and processes immediately shown, or show improvement only after a certain period of time. Purpose: Evaluation of the real situation and preparation and implementation of the quality method for identifying and assessing the risks and opportunities that will be met by all the requirements of the new standard ISO 9001: 2015 and consequently the handling of complaints. The aim of the research is to determine how the introduction of FMEA in the organization effects on the customer complaints. Method: We used an organization database containing the number of DFMEA and PFMEA functions introduced and the number of complaints from 2015 to 2017. For analysis we used descriptive statistics, multiple regression, Pearson correlation coefficient and dependent ANOVA test. Results: The introduced methodology for identifying and assessing the risks of the FMEA (comprehensive quality tool) in the field of research and development, i.e. DFMEA and for the field of processes i.e. PFMEA. We have confirmed a significant reduction in customer complaints due to the introduction of DFMEA and PFMEA functions and processes. The improvement has been shown two years after its launch. Organization: For an organization, this is a big step in terms of advancement towards TQM. It means the transition to a new standard or a new quality system ISO 9001:2015, and thus the introduction of a process approach, the operation of the PDCA cycle, and the introduction of risks and opportunities at all levels in the organization or in all areas to think on the basis of risk. Society: The results are more favorable for the use of our products, because of the more reliable production, the companies are more competitive, productivity increases, the costs of non-quality are reduced, and emissions are reduced to the environment. Originality: The introduced method for identifying and assessing FMEA risks, although not required by the ISO 9001: 2015 standard. Limitations/Future Research: As part of our research, we were limited to only one company where the introduction of the FMEA method was remunerated. In order to get a wider picture of the results of the FMEA introduction, the research should be extended to several companies that have already introduced the FMEA method.