Perdigão, FilipeJacinto, CelesteLopes, SandraMatos, Ana Sofia2019-03-012019-03-0120172077-7973PURE: 3725776PURE UUID: 816d6570-f719-4cd8-8eb4-05d65a8037caScopus: 85042761669ORCID: /0000-0002-1292-0782/work/49897056ORCID: /0000-0002-4659-0275/work/69844142http://www.scopus.com/inward/record.url?scp=85042761669&partnerID=8YFLogxKThe authors are grateful to Lusosider, namely to the personnel of quality, safety, and environmental department and the several heads of other departments, for their helpful collaboration in this study. This research work was partially sponsored by UNIDEMI Research Unit (ref. PEst-OE/EME/UI0667/2014).The recent 2015 edition of ISO 9001 introduces a risk-thinking approach in its new section 6.1. Comparing with previous editions of the standard, the main innovation is the need to address risk and identify improvement opportunities within quality management processes. The aim of this work was to show how the new requirements can be fulfilled. This was achieved through a case-study in an industrial company, by applying a structured analysis to a specific management process. This paper describes a practical example, demonstrating how this type of analysis can be applied to any management process within a companies' quality system. Two methods were used; the first was Failure Mode and Effect Analysis (FMEA/FMECA), and the second was a Hazard and Operability Study (HAZOP). In the latter case, the authors used the designation QF-HAZOP to highlight the fact that this is a HAZOP study applied to the analysis of Quality Functions. The current work is restricted to the study of main process (management function) "Sales", for which the analysis of a particular sub-process, "Sales plan development", is herein presented and discussed step-by-step, to give insight of details. Within "Sales plan development", the results revealed 10 failure modes that, in turn, can originate from 17 potential causes that were organized into 4 "sets of causes" because certain failure modes share the same causes and require similar improvement actions; these are also pinpointed in this paper. With regard to the main process "Sales", this analysis disclosed 38 sets of causes that were categorized by risk level, i.e., by their risk priority number (NPR), using a Pareto Diagram, to establish intervention / improvement priorities. It was also found that, apparently, either FMEA/FMECA or the adapted QF-HAZOP produce similar results. Both constitute useful approaches to fulfil the new requirements of ISO 9001:2015 Quality Standard.102394751engFMEA / FMECAHAZOPISO 9001:2015QualityQuality managementRisk analysisRisk-based thinkingManagement of Technology and InnovationOrganizational Behavior and Human Resource ManagementStrategy and ManagementArtificial IntelligenceInformation Systems and ManagementSDG 9 - Industry, Innovation, and Infrastructurejournal articlehttps://www.scopus.com/pages/publications/85042761669