Abstract Purpose – The purpose of this paper is to develop an instrument that measures the effectiveness of the ISO 9001 Quality Management System (QMS), based on its components, meaning the ISO 9001 objectives; and to validate this instrument in the food manufacturing sector. Design/methodology/approach – Bearing in mind the definition of "ISO 9001 effectiveness", the ISO 9001 objectives and their indicators are identified in the literature. Based on these indicators, a measurement instrument is developed and then empirically validated through collecting preliminary data from 335 Greek food manufacturing small and medium‐sized enterprises (SMEs). After testing the assumptions of multivariate analysis, exploratory factor analysis as well as first and second order confirmatory factor analysis are applied. Findings – The data collected reveal, as identified in the literature, the three‐dimensional nature of the ISO 9001 objectives (continuous improvement, prevention of nonconformities and customer satisfaction focus). The responding food manufacturing SMEs demonstrate a high level of achievement of these objectives. Further analysis of the data also reveals a valid latent factor reflecting the successful achievement of the ISO 9001 objectives, namely "ISO 9001 effectiveness". Research limitations/implications – The present study focuses on food manufacturing SMEs. Therefore, it is worth validating the measurement instrument on large food manufacturing companies, food service companies, companies of specific food sub‐sectors, non‐food companies and finally on companies operating in different economic conditions to Greece. Practical implications – This measurement instrument can be used by a food manufacturing SME as a self assessment tool and a benchmarking tool. In doing so, suitable strategies can be selected in order for a food SME to improve quality, gain competitive advantage and overcome the current downturn. Originality/value – In this paper, a measurement instrument is developed and validated in food manufacturing SMEs, based on measures describing the ISO 9001 objectives; in other words, ISO 9001 effectiveness.
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