ISO 9001 Certification and Level Five Hospitals' Performance in North Rift Region, Kenya

Abstract

Level Five public hospitals in Kenya’s North Rift Region continue to experience challenges in service delivery, resource management, patient waiting time and satisfaction, highlighting the need for effective quality management practices. This study examined the effect of customer focus and process approach, as selected ISO 9001 quality management dimensions, on organisational performance in Level Five public hospitals. Anchored on Total Quality Management and supported by General Systems Theory, Kaizen and SERVQUAL, the study adopted an explanatory sequential mixed-methods design. The target population comprised 320 staff from Iten, Kapenguria, Kitale and Kapsabet County Referral Hospitals, from whom 178 respondents were proportionally sampled and randomly selected. Data were collected using questionnaires, key informant interviews and document review, and analysed using descriptive statistics, Pearson correlation, multiple linear regression and thematic analysis. Both customer focus and process approach significantly predicted organisational performance. Customer focus was the strongest predictor (β = 0.298, p < 0.001), followed by process approach (β = 0.251, p = 0.001). The study concluded that ISO 9001 quality management dimensions enhance hospital performance when authentically implemented. It recommended strengthening patient feedback mechanisms, enforcing documented procedures, institutionalising continuous improvement and enhancing the use of routine performance data for decision-making