Title: Diagnosis framework for quality management system in blood banks: a Brazilian case study

Authors: Vinícius G. De Lemos; Vítor Z. Bernardo; Matheus De S. Dall'Agnol; Leonardo P. Ruli; Andrew M. Bacelar; Ana C. Honda; César J.C.M. Da Costa; Mateus C. Gerolamo

Addresses: Department of Production Engineering, University of São Paulo, Trabalhador São Carlense Av., 400, 13566-590 – Center, São Carlos, SP, Brazil ' Department of Production Engineering, University of São Paulo, Trabalhador São Carlense Av., 400, 13566-590 – Center, São Carlos, SP, Brazil ' Department of Production Engineering, University of São Paulo, Trabalhador São Carlense Av., 400, 13566-590 – Center, São Carlos, SP, Brazil ' Department of Production Engineering, University of São Paulo, Trabalhador São Carlense Av., 400, 13566-590 – Center, São Carlos, SP, Brazil ' Department of Production Engineering, University of São Paulo, Trabalhador São Carlense Av., 400, 13566-590 – Center, São Carlos, SP, Brazil ' Department of Production Engineering, University of São Paulo, Trabalhador São Carlense Av., 400, 13566-590 – Center, São Carlos, SP, Brazil ' Blood Bank of the Holy House of Mercy of São Carlos, Paulino Botelho de Abreu Sampaio St., 535, 13561-060, São Carlos, SP, Brazil ' Department of Production Engineering, University of São Paulo, Brazil

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.

Keywords: diagnosis framework; quality management system; QMS; quality diagnostic; blood bank; ISO 9001:2015; Brazil case study.

DOI: 10.1504/IJPQM.2021.113611

International Journal of Productivity and Quality Management, 2021 Vol.32 No.2, pp.265 - 277

Received: 26 May 2018
Accepted: 07 Jun 2019

Published online: 03 Feb 2021 *

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