Risk-based thinking according to ISO 9001:2015 standard and the risk sources European manufacturing SMEs intend to manage

Abstract

Purpose The purpose of this paper is to theorize and prioritize the main categories of risk sources for the European manufacturing small- and medium-sized enterprises (SMEs) in accordance with the International Organization for Standardization (ISO) 9001:2015 requirement “risk based thinking.” Furthermore, the research analyses how these organizations intend to manage the risks and their effects. Design/methodology/approach A first exploratory interview with 28 experts from international certification bodies and manufacturing companies which revealed 11 risk sources has been performed. Then, quality managers from European manufacturing SMEs were surveyed to determine whether or not they intended to manage the risk sources suggested by the experts. A 95 percent confidence interval was performed to evaluate the range of plausible values for the population. The quality managers were also asked to comment on each category of risk source. Findings The research shows that the most taken into account categories of risk sources were the internal production of nonconforming products followed by poorly trained workers with a lack of skills and awareness, supplier nonconforming products and lack of risk-based assessment. The least taken into account category was nonconforming technical results in the design process. The quality managers’ qualitative comments also brought to light interesting issues which represented avenues for new research. Research limitations/implications The limitations of this research lie in the first exploratory interview with the 28 experts. This process could be improved by means of a larger sample of experts. Furthermore, these experts could have included risk source categories which could fall outside of an ISO 9001 quality management system (QMS) scope and application. Practical implications Quality managers in SMEs can now address the new ISO 9001:2015 requirement knowing what the priorities from a statistical point of view are. This implication is also relevant to QMS consultants who are implementing ISO 9001:2015 QMS together with their customers. Originality/value The novelty of this research is that it has been tried for the first time to theorize what the main categories of risk sources in accordance with the risk-based thinking requirement are for European manufacturing SMEs.