Document Detail


ISO 15189 accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory II.
MedLine Citation:
PMID:  19863921     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: Our laboratory was accredited for 531 tests according to ISO 15189 standard (ISO 15189:2003 Medical laboratories--Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories) in 2007. An ambitious and young group of laboratory personnel has spent efforts with commitment and dedication to complete the heavy work of preparation and passed through assessment with success. We herewith share our experience of the accreditation, the stages we have been through; our solutions to obstacles which we came across during the process. DESIGN AND METHODS: Our approaches to topics of environmental conditions, document management system (CentroDMS), use of the laboratory information system (CentroLIS), corrective/preventive actions and measurement uncertainty are summarized in this article. RESULTS: Experience of our laboratory in different areas of ISO 15189 accreditation is presented in summary. CONCLUSION: Accreditation of medical laboratories increases the quality of the results, motivates the laboratory personnel and is beneficial for all interested bodies. Continuous improvement and dedicated people are the key elements for continuation of the quality assurance in an accredited medical laboratory.
Authors:
Gulderen Yanikkaya-Demirel
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Clinical biochemistry     Volume:  42     ISSN:  1873-2933     ISO Abbreviation:  Clin. Biochem.     Publication Date:  2009 Mar 
Date Detail:
Created Date:  2009-10-29     Completed Date:  2009-12-30     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0133660     Medline TA:  Clin Biochem     Country:  United States    
Other Details:
Languages:  eng     Pagination:  279-83     Citation Subset:  IM    
Affiliation:
Centro Laboratuvarlari, Istanbul, Turkey. gydemirel@centro.com.tr
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MeSH Terms
Descriptor/Qualifier:
Accreditation / standards*
Clinical Competence / standards*
Documentation
Environment
International Agencies / standards*
Laboratories, Hospital / standards*
Professional Competence / standards*
Quality Control
Reproducibility of Results
Uncertainty
Weights and Measures

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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