Modeling critical success factors for ISO/IEC 17025 implementation: a DEMATEL-based approach

Abstract

Purpose The Management System Standard ISO/IEC 17025 aims to enhance the performance, service quality, accuracy and credibility of measurements in accredited testing and calibration laboratories. This study focuses on modeling the critical success factors (CSFs) that contribute to the implementation of ISO/IEC 17025, categorizing them into cause-and-effect groups and determining their causal relationships to support successful adoption of the standard. The study also compares the viewpoints of technical personnel and laboratory managers to identify potential differences in how these expert groups form the underlying cause-effect structure of the CSFs. Design/methodology/approach To address the study objectives, Decision Making Trial and Evaluation Laboratory analysis was applied separately to the 2 groups of experts, using data from 23 questionnaires collected in Greece across three types of laboratories: civil engineering, chemical and calibration. The analysis focused on a set of CSFs, which were drawn from a classification developed through a systematic literature review and validated by domain experts. Findings The key causal factors for successfully implementing ISO/IEC 17025 include strong leadership and strategic commitment, motivation for accreditation, regulatory compliance, customer focus and adequate financial and organizational resources. These elements form the foundation for the successful adoption of the standard. Conversely, the primary effect factors (i.e. those that are driven by the causal factors) include the core technical requirements set by ISO/IEC 17025 – such as quality assurance and control, method verification and measurement traceability and technical resources – in addition to performance management and improvement. Comparing the perspectives of the two expert groups in the study, while both largely agree on the key cause-and-effect factors that optimize laboratory performance, they perceive the dynamics driving these relationships differently. Managers tended to emphasize the regulatory framework, customer needs, and strategic planning related to the laboratory's sustainability and financial objectives. In contrast, technical personnel placed stronger emphasis on the standard's technical aspects as the primary effect factors and highlighted leadership and motivation for accreditation as the most critical causal influences. Notably, the factor operational integrity and impartiality was identified as significant factors by both groups; however, technical personnel viewed them primarily as causal and mediating factors, while managers considered them mainly as effect factors. The overarching conclusion of this study is that accreditation alone does not ensure a laboratory's credibility, as the technical requirements of ISO/IEC 17025 are influenced by a combination of managerial factors, as well as organizational integrity and independence. Practical implications The findings of this study encourage laboratory management to treat ISO/IEC 17025 as a strategic framework rather than a technical checklist, emphasizing leadership commitment and the effective allocation of resources to support reliable measurement results. Social implications Public policymakers can use the insights of this study to refine regulatory oversight and procurement practices, reinforcing the independence and quality culture needed to protect public safety and the integrity of tested materials. Originality/value This study is the first to systematically model the CSFs for implementing ISO/IEC 17025 while also comparing the resulting structures between technical personnel and laboratory managers.