Systematic Identification and Validation of Critical Success Factors for ISO/IEC 17025 Implementation

Abstract

In the broader context of quality management, testing and calibration laboratories are increasingly adopting ISO/IEC 17025 accreditation as a key benchmark for achieving operational excellence. This management system standard outlines the essential requirements laboratories must meet to demonstrate their technical competence and produce accurate, reliable results. This study aims to identify and validate the Critical Success Factors (CSFs) for effective ISO/IEC 17025 implementation. It begins with a systematic literature review focusing primarily on ISO/IEC 17025, supplemented by insights from other established standards such as ISO 9001 and ISO 14001 to enrich the findings. This study employed an interview-based qualitative approach to validate and refine the identified CSFs. This entailed conducting 34 semi-structured interviews with a diverse group of industry professionals—including technical managers, quality managers, auditors, and clients—from calibration, chemical, and civil engineering testing laboratories. The findings led to the establishment of 16 CSFs, including leadership and strategic commitment, motivation for accreditation, allocation of financial and organizational resources, and the provision of technical infrastructure. Also crucial are the management of human resources—competency, training, and engagement—and key quality management elements such as effective system design, method verification, measurement traceability, quality assurance, control, and performance improvement. Additional factors include fostering a quality-oriented culture, ensuring operational integrity and impartiality, managing supplier relationships, focusing on customer needs, and adhering to regulatory compliance. Recognizing these CSFs enables organizations to focus on pivotal areas, streamline monitoring processes, and align with strategic objectives. This study represents the first in-depth exploration into the CSFs for ISO/IEC 17025 implementation within testing and calibration laboratories, thereby contributing directly to enhancing their quality and operational performance.

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