A CRITICAL ANALYSIS OF ISO/IEC 17025 PRACTICES AT UNIKL MITEC LABORATORY TOWARDS IMPROVEMENT OPPORTUNITIES

Abstract

This research critically examines UniKL MITEC laboratories' compliance with ISO/IEC 17025:2017 accreditation standards. The laboratories have not achieved full accreditation for an extended period, necessitating a comprehensive assessment of their practices. A qualitative and quantitative approach involving interviews, observations, and gap analysis was employed. The self-assessment checklist, designed by the researcher, measured the laboratory's readiness for accreditation certification. Descriptive statistics revealed that the laboratory's compliance with clause 8, focusing on management requirements, is currently at a modest 40%. This signifies a significant gap between their current practices and the minimum compliance level. The study further assessed specific clauses within clause 8, ranging from 8.1 to 8.9, revealing that the least compliance observed was at 37.5%, while the highest was only 42.5%. A Pareto analysis highlighted that clause 8.2 and 8.5 are the major contributors to non-compliance, accounting for over 30% of the cumulative gap percentage. Notably, clause 8.2 exhibited the most significant gap, with 59 individual gap levels identified. The research delves into a detailed cause-and-effect analysis, investigating the root causes of noncompliance within the laboratory's current practices concerning clause 8. Proposed improvements align with management concepts and ISO/IEC 17025 standards. In essence, this research serves as a valuable contribution to enhancing laboratory practices, ensuring alignment with international standards, and identifying opportunities for improvement in management requirements.