The quality management processes seek to cope with changes in an increasingly complex and dynamic environment while ensuring that organizations are able to deliver products and services that comply and satisfy their customers (Fonseca, 2015). The ISO 9000 series of international standards has become an important reference and a key management structure for all types of organizations around the world (Fonseca & Domingues, 2017). The update of the ISO 9001: 2015 standard presents a thinking based on risk management and process-based approaches, which highlights the growing emphasis on risk management within quality management programs (Sitnikov et al., 2017).Failure Modes and Effects Analysis (FMEA) is one of the most well-known quality management tools used to deal with risk assessment in continuous improvement programs for products, processes, and services (Kumru & Kumru, 2013). The literature presents a large number of studies that apply the FMEA in several problems, such as: applications to reduce medical errors (
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