Evaluation of ISO 9001:2015 System Implementation Based on Gap Analysis and Root Cause Analysis
Case Study: Electronic Manufacturing Industry
Abstract
Intensifying competition in the electronic manufacturing industry requires companies to maintain consistent product and process quality. The ISO 9001:2015 Quality Management System has become a crucial strategy widely adopted for this purpose, as it provides a systematic framework to control processes, reduce variation, and enhance customer trust. In practice, however, its implementation often stops at the stage of certification formality without an in-depth evaluation of its effectiveness, potentially creating a gap between system documentation and actual practice. This study aims to assess the compliance level of ISO 9001:2015 implementation and to trace the root causes of nonconformities within critical clauses, employing a descriptive-evaluative case study design with a mixed methods approach. Gap Analysis was applied to measure the compliance level across clauses 4 through 10, while the 5 Whys method was used to analyze the root causes of nonconformities in the lowest-scoring clause. The findings reveal that the overall compliance level reached an average of 94.04%, indicating that the quality management system has been effectively maintained. Nevertheless, the support clause (Clause 7) was identified as the critical clause with the lowest score of 88.60%, particularly regarding human resource competency and awareness. Root cause analysis revealed that the main constraint lies not in the absence of a training program, but in the lack of a structured training curriculum. Accordingly, this study recommends developing a competency-based training curriculum accompanied by multilevel evaluation as a practical improvement measure for the company. This study underscores the importance of integrating quantitative evaluation with qualitative analysis to support the effectiveness and sustainability of ISO 9001:2015 implementation in the electronic manufacturing industry.
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