The purpose of the study is firstly, to empirically validate the conceptual structure of the effectiveness of the ISO 9001 quality management system (QMS) in manufacturing companies and secondly, to determine the critical factors that have a significant impact on the QMS’s effectiveness. A research study was carried out through a structured questionnaire in a sample of 163 ISO 9001 certified Greek companies. Exploratory and confirmatory factor analyses are applied to extract and validate latent constructs, while their relationships are determined through structural equation modelling. The analyses confirm the conceptual factorial structure of the ISO 9001 QMS’s effectiveness which consists of three dimensions – the ISO 9001 objectives (prevention of non-conformities, continuous improvement and customer satisfaction focus). The analysis also confirms the five dimensions of the critical factors for ISO 9001 QMS effectiveness identified in the literature (internal motivation, external environment pressure, company attributes, employee attributes and quality system attributes). However, only the company internal motivation, company attributes and employee attributes have a significant impact on the ISO 9001 QMS’s effectiveness.
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