ISO 9001:2015 and Its New Requirement to Address Risk: A Demonstration Case-Study

Abstract

The recent 2015 edition of ISO 9001 brings an innovative risk-thinking approach in its new section 6.1. Comparing with previous editions of the standard, the main innovation is the introduction of risk analysis and identification of 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 work covered three vital management functions, including “Maintenance”, “Human Resources” and "Sales". In this paper, only the last one is thoroughly analysed and discussed. The methods applied allowed identifying and scrutinizing 23 specific activities (functions) associated with around 54 risk factors (failure modes). After being categorised by risk level (or hierarchy of priorities), these risk factors provided a way of finding improvement opportunities. This work shows that either FMEA/FMECA or the adapted QF-HAZOP constitute useful approaches to fulfil the new requirements of ISO 9001:2015 Quality Standard.