Abstract
Healthcare organisations face many challenges regarding market competitiveness, client expectations and regulatory demands. Quality management systems (QMS) have emerged as effective support tools for managers and the demand for ISO certification has increased. However, the process of diagnosing the QMS before certification is often complex, time-consuming and expensive. This article proposes a framework for QMS evaluation consisting of a diagnostic tool for blood banks. The methodology combines a set of international quality standards, change management principles and process mapping tools. It can be applied through internal audits, thus it is useful for organisations that seek relevant certification to define the next steps to be taken for improvement. A case study in a Brazilian blood bank illustrates the results of the framework. The pilot of the diagnostic tool was successful in identifying gaps that required further development by presenting maturity levels for each requirement of the international standards.
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