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.

随着 2015 年 ISO 9001 的更新，既定要求之一是基于风险的思维 (RBT)，这是许多作者讨论的重要主题。本文旨在寻找对 ISO 9001:2015 和风险方法文献的相关贡献，批判性地分析现有研究并为研究人员和组织提供新的视角。为了实现这一目标，作者进行了系统文献回顾 (SLR)，通过确定研究的主要主题 (a)、使用定义的标准 (b) 定位研究、运行分析和执行综合 (c) 并报告结果(d)。从 SLR 论文中，构建了五个集群，从而确定了最常见的方法及其约束。大多数论文对 RBT 的看法是零散的，大多数作者选择 FMEA，但 RBT 不仅仅是“进行风险管理”。组织的最佳选择是脱离常规做法，以综合方式解决问题，将广泛的方法与日常实践系统地结合起来，嵌入组织文化中。本研究的结果通过将实际实践与 ISO 9001:2015 的要求进行对比，从 RBT 实施的不同角度提供了有用的见解，从而增强了现有的 RBT 知识。