[Conceiving and implementing an ISO 9001:2000 quality management system: quality improvement and efficiency increase over 3 years at the Dept. of Ophthalmology, Sultan Qaboos University in Oman].

Background: Oman is a developing country of the Middle East with a University Hospital in a national health system. Problems related to documentation, structure, and procedure prevailing in a multicultural environment result in a lack of productivity. The aim of this study was to test the feasibility of introducing a quality management system according to ISO 9001:2000 into a university department of ophthalmology with special reference to quality and efficiency data over 3 years.

Materials And Methods: Standardized types of documentation (35 documents, 183 forms and formats, and 453 registers) under a formal roof (booklets for work instructions, quality management, procedures) were conceived in 2001 and implemented, and were evaluated by descriptive statistics over the years 2002-2005 with respect to quality and efficiency. In 2005, the departmental QMS was merged into the QMS of the whole hospital.

Results: Establishment of "responsibility clusters" with structured surveillance tasks, procedural improvements, and continuous audits resulted in a significant quality improvement already during the implementation until ISO 9001:2000 certification in 2002, and over the following 3 years. The data were assessed by non-conformities documented monthly (total inpatients: -50%, outpatients: -20%, operating theater: -100%, teaching: -10%; p <0.05) and increased efficiency assessed by the most important performance indicators (before QMS vs a median of 3 years with QMS): major surgery: +459%, inpatient stay: -49.7%, occupancy rate: +63.9%, technical diagnostics: +292.9%, postgraduate teaching total: +740%, research output total: +330% (p <0.05).

Conclusions: It is feasible to introduce the quality management system according to ISO 9001:2000 into a developing country in the Middle East. It has an immediate effect on the increase of efficiency (measured by performance indicators) and quality in all systems providing the possibility for regional benchmarking.