Impact of ISO 9001:2015 Quality Management System Implementation on Reducing Operational Deviations

Abstract

The ISO 9001:2015 standard represents one of the most important international frameworks for quality management systems, as it provides an organizational methodology that helps institutions improve the efficiency of operations and enhance continuous improvement in institutional performance. Despite the widespread application of this standard, some institutions still rely in internal auditing on traditional methods that focus on reviewing records after problems occur, which may lead to delays in detecting operational deviations and weaken the ability to take preventive actions at the appropriate time. This study aims to analyze the impact of the level of implementation of the requirements of the ISO 9001:2015 standard in reducing operational deviations within institutions, through the use of a statistical model based on multiple regression analysis to determine the dimensions that are most influential in reducing cases of non-conformity. The study adopted the descriptive analytical approach, and data were collected using a questionnaire distributed to a stratified random sample of 100 respondents from employees working in four companies operating in the field of inspection and conformity assessment in Libya. The sample included technical managers, quality managers, internal auditors, in addition to engineers and technical supervisors associated with the implementation of operational processes and the application of the quality management system within these companies. The data were analyzed using SPSS through the mean and standard deviation, in addition to multiple regression analysis and analysis of variance (ANOVA) to verify the significance of the statistical model. The results showed the existence of a significant effect of the dimensions of the implementation of the quality management system represented in leadership, planning, operational process efficiency, and continuous improvement in reducing operational deviations within institutions. The results also showed that the dimensions of operational process efficiency and continuous improvement represent the most influential factors in reducing cases of non-conformity. These results indicate the importance of strengthening the implementation of the requirements of the ISO 9001:2015 standard and employing statistical methods to support internal auditing processes and improve the ability to detect operational deviations at early stages.