Case Study On Audit

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Recommended: ISO 13000 quality management

Introduction
Audit is a systemic and independent documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled (1) .
Audits are carried out annually in all departments to ensure there is conformity to the quality management systems within the hospital according to the international standard ISO 15189. In order to facilitate an effective quality management system, the international standard 9001 provides guidelines for this to occur.
There are 6 types of audits. Horizontal audit is a detailed check of a particular aspect of the process/documentation and implementation of the quality management system against the ISO 15189 standards across many departments. Hemovigilance audits are performed both inside and outside the laboratory by the Hemovigilance office (HVO). Examination / Witness …show more content…

In this case, it was the 2 coagulation samples for paediatric and adult. It was a detailed audit to see if the laboratory is following the management and technical documents. If there are any issues with document or the processing of the sample. This is recorded as non-confirmatory (NC) and corrective prevention action is put into the audit to improve the overall effectiveness of the quality management system and updated to Q-pulse. In the haematology laboratory a vertical audit was carried out twice a year. This includes the processes from when the sample enters the laboratory, labelling, testing and reporting of the results. Audit is carried out by lead auditor who is an independent of those having direct responsibility for the activity being audited, and qualified on the basis of appropriate education, training and/or experience and knowledge of ISO 15189. They have the responsibility for the performance of the audit. Also, witness audit is when an examination procedure is witnessed as it is

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