The Relationship between ISO/IEC 17025 Adoption and Operational Performance of Testing and Calibration Laboratories

Abstract

This paper examines the relationships between the demand for market needs, preparedness of the laboratories, leadership, quality culture and operational performance. It addresses the critical success factors, namely, the internal and external factors, quality cultures (i.e., rational and developmental) and operational performance in addressing the effectiveness of the ISO/IEC 17025 implementation in testing and calibration laboratories. Using a data set of 163 respondents who are in charge of daily operations of the laboratories in 29 countries, reliability and validity analyses were conducted on the study instruments. The results showed that all the Composite Reliabilities values for the selected items have exceeded the minimum value of 0.7. Structural Equation Modeling (SEM) was used to analyse the interrelationships of the variables involved with Partial Least Squares method adopted to compute the path model. The results showed that external factors exerted positive impacts on internal factors, while internal factors had positive impact on leadership and rational culture, respectively, which subsequently influenced the laboratories’ operational performance.  However, the external factors’ influence on leadership and developmental culture were not significant. Leadership not only had a strong influence on the creation of both types of culture, but it also had a great impact on the operational performance of the laboratories. Both rational and developmental cultures had significant impacts on the laboratories’ operational performance.