ISO 15189 accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory II

Abstract

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.