Quality Management and Quality Assurance in Medical Laboratories

Author:

Tsimillis Kyriacos C.1,Michael Sappho2

Affiliation:

1. Cyprus Accreditation Body, Cyprus

2. Ministry of Health, Cyprus

Abstract

This chapter deals with issues of quality management and quality assurance in medical laboratories. Basic terms and their role in quality assurance in laboratory examinations are analyzed and discussed. Clarifications on certification and accreditation are given with a comprehensive analysis of the procedures they refer to and their implementation for particular tasks. The implementation of the international standard ISO 15189 is presented with reference to some recent developments. The chapter has been prepared to help medical laboratories in an introductory understanding of quality assurance issues and encourage them to proceed with the implementation of the standard ISO 15189 and not as a detailed guide. Some practical considerations rising from the experience of a small country such as Cyprus are also discussed.

Publisher

IGI Global

Reference26 articles.

1. Archondakis, S., Stathopoulou, A., & Sitaras, I. (2011). ISO 15189:2007: Implementation in a laboratory information system. In A. Moumtzoglou & A. Kastania (Eds.), E-Health Systems Quality and Reliability: Models and Standards (pp 64-72). Hershey, PA: IGI Global.

2. Eleftheriadou, M., & Tsimillis, K. C. (Eds.). (2013). Accreditation for microbiological laboratories (2nd ed.). Retrieved February 2, 2014, from www.eurachem.org

3. European cooperation for Accreditation. (2002). EA-4/10 G: Accreditation for microbiological laboratories. Retrieved February 2, 2014, from www.european-accreditation.org

4. European Cooperation for Accreditation. (2008). EA-4/17 M: EA position paper on the description of scopes of accreditation of medical laboratories. Retrieved February 2, 2014, from www.european-accreditation.org

5. Hubca, A., Koniotou, R., Gligic, L., Noten, V., Zdilna, P., Kastrop, P., & Greven, I. (2013, June). Comparison ISO 15189:2007 vs ISO 15189:2012. Paper presented at the meeting of the EA WG “Healthcare”. Frankfurt, Germany.

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1. Training needs to understand quality assurance;Accreditation and Quality Assurance;2014-12-12

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