Validating the theoretical underpinnings of the ISO 9001:2015 quality management system standard : a multi-country study : a thesis presented in partial fulfilment of the requirements for the degree of Doctor of Philosophy in Engineering at Massey University, Manawatu, New Zealand

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Massey University
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ISO 9000 family of quality management system (QMS) standards — particularly ISO 9001, which stipulates QMS requirements for compliance — have received a great deal of attention by academia and practitioners. Every year, thousands of organisations obtain ISO 9001 certification worldwide, and a plethora of studies have examined the effectiveness of ISO 9001 implementation, empirically or otherwise. One existing knowledge gap is the absence of a comprehensive study that examines the theoretical validity of ISO 9001. Another is ascertaining how ISO 9001 compliance requirements are accepted across countries and regions, given that ISO 9001 is meant for sociotechnical systems. Using responses received from 240 ISO 9001 certified manufacturing companies in five countries, this study empirically examined the theoretical validity of ISO 9001:2015, which is claimed to underpin Plan-Do-Check-Act (PDCA) at the overall QMS level. The theoretical model of the study which posited that “Leadership Driven QMS Planning (LDQMSP) (reflected via clauses 04 through to 07 of the standard) leads to implementing the planned processes (reflected via clause 08), and checking the effectiveness of these processes (reflected via clause 09) and taking appropriate action (reflected via clause 10) leads to QMS Results” was found to be a good fit to data, based on goodness of fit criteria used in partial least squares structural equation modelling. As regards national culture effects and regional effects (Australasia, South Asia, and Greece), the empirical test results found that national culture (or region) plays only a very minor role in making ISO 9001 based continual improvement (PDCA) of the QMS being more acceptable to certain cultures than to others; power distance (PDI) and individualism (IDV) showed positive and negative effects (but small) respectively on Plan (LDQMSP), Do, Check, Act, and QMS Results as hypothesised. However, uncertainty avoidance (UAI) failed to show a significant effect (α = 0.05). Similarly, the mean scores of Plan (LDQMSP), Do, Check, Act, and QMS Results of South Asia were found to be higher than those of Australasia, although these effects were small. Thus, the findings support the universal relevance and acceptance of the standard, although the study was limited to ISO 9001 certified manufacturing firms of five selected countries. Contributions of the findings were highlighted, and further research directions were suggested.
ISO 9001 Standard, Quality control, Standards