Assessment of factors that contribute to non-compliance during SANAS audits in the Midlands business unit from 2020 to 2023

Abstract

Accreditation of medical laboratories is a critical requirement for ensuring quality, reliability, and compliance with international standards such as ISO 15189. In South Africa, the South African National Accreditation System (SANAS) evaluates laboratories to maintain standards of competence, accuracy, and patient safety. Despite accreditation, non-conformances (NCs) remain a recurring challenge during audits. This study assessed the factors contributing to non-compliance during SANAS audits in the National Health Laboratory Service (NHLS) Midlands Business Unit from 2020 to 2023. A descriptive, retrospective, non-experimental quantitative research design was employed. The study population included all SANAS-accredited laboratories in the Midlands BU (N=7). Data were extracted from SANAS audit records, with a focus on NCs raised during the 2020–2023 period, and triangulated with perceptions from purposively selected internal auditors through an online survey. Descriptive statistics were used to analyse trends, and thematic grouping identified recurring NC categories. Results showed that NCs fluctuated across the period, but persisted in core areas, including documentation and SOP management, training and competency assessment, corrective and preventive action (CAPA) monitoring, and weaknesses in management review meetings. Analytical and post-analytical deficiencies, such as equipment maintenance lapses, QC miscalculations, and inconsistent communication of critical results, were also noted. Survey findings reinforced these themes, with auditors reporting incomplete training records, delayed CAPA implementation, and systemic weaknesses in document control and accountability structures. The study concludes that non-conformances during SANAS audits in the Midlands BU are driven by systemic quality management challenges compounded by human factors such as SOP non adherence. Strengthening CAPA processes, enhancing training and competency frameworks, embedding SOP discipline, and reinforcing management accountability are recommended to sustain ISO 15189 compliance.