Requirements for the application of quality management in the work of medical laboratories within the standard 15189 "A Case Study at Alawiya Women's and Childbirth Hospital"

Abstract

Abstract:

It is essential to provide health care directly or indirectly based on laboratory tests in order of diagnosing diseases. There is an urgent need for the results of such tests to be accurate and reliable. Therefore, the International Organization for Standardization has prepared special standards for medical laboratories to prove their efficiency, presented in standards 15189: 2012. The aim of the research is to determine the possibility of the Al-alwiya Women's Hospital in meeting the requirements of the standards 15189: 2012, which includes administrative requirements consisting of fifteen items and technical requirements consisting of ten items. The research is important because laboratories should obtain a certificate of reliability to prove the efficiency and accuracy of test results. A special checklist of accreditation designed and approved by Iraqi accreditation board that covers all the requirements of the standards that should be complied with by an operating laboratory.  In the event of a minor non-compliance case, the laboratory can close the case and provide documentations to prove that.  For critical and major non-compliance case, accreditation officer from the accreditation board need to visit the laboratory to ensure closure of the case and compliance with the requirements