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[Recommendations for implementing the UNE-EN-ISO 15189 quality standard in the clinical microbiology laboratory: bacteriology and serology].

Authors: María Dolores, Rojo; Juan Manuel, Aguiar; Emilia, Cercenado; Fernando, de Ory; Manuel, de la Rosa;

[Recommendations for implementing the UNE-EN-ISO 15189 quality standard in the clinical microbiology laboratory: bacteriology and serology].

Abstract

The UNE-EN-ISO 15189:2007 standard specifies the management and technical requirements that clinical microbiology laboratories must meet to achieve optimal quality when performing microbiological analyses. With implementation of this standard, a laboratory can receive the accreditation and formal recognition of an authorized body, certifying that it is apt for performing an assay or group of assays. In Spain, laboratories that apply these standards can be accredited by the Entidad Nacional de Acreditación (ENAC, Spanish accreditation body). The purpose of this review is to familiarize clinical microbiology laboratory specialists with the UNE-EN-ISO 15189:2007 standard through a practical approach focussed on bacteriology and serology studies. We briefly define the scope and specify the requisites required for managing the quality of the procedures and processes involved in performing tests on human specimens, for document control, and for management of instruments and equipment, personnel, information systems, supply systems, and external services. Lastly, evaluation approaches are indicated to achieve continuing improvement of the processes carried out and the services the laboratory provides.

Keywords

Quality Control, Bacteriological Techniques, Practice Guidelines as Topic, Humans, Serologic Tests, Laboratories

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Powered by OpenAIRE graph
Found an issue? Give us feedback
selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
6
Average
Top 10%
Average
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