ISO 9001:2015 and risk-based thinking: scientific research insights

Abstract

With the update of ISO 9001 in 2015, one of the established requirements was risk-based thinking (RBT), a significant subject discussed by many authors. This paper aims at finding relevant contributions to the literature on ISO 9001:2015 and risks approach, critically analysing the existing studies and providing new perspectives for researchers and organisations. To achieve it, the authors conducted a Systematic Literature Review (SLR), by establishing the main subject matter of the research (a), locating studies using defined criteria (b), running the analysis and performing a synthesis (c) and reporting the results (d). From the SLR papers, five clusters were structured, leading to the identification of the most frequent approaches and their constraints. Most papers present a fragmented view of RBT and the majority of authors opt for FMEA, but RBT goes beyond simply 'doing risk management'. The best option for organisations departs from usual practices and approaches the issue in an integrated manner, with a systemic combination of widespread methods with daily practices, embedded in organisational culture. The results of this study enhance the existing knowledge on RBT by confronting the actual practices with the requirements of ISO 9001:2015, providing useful insights, from different perspectives on RBT implementation.