ISO 15189 is an international standard which outlines minimum requirements for quality and competence in medical laboratories. This standard provides guidance on how to safely conduct laboratory testing while ensuring continual improvement and consistency in testing. It is important for laboratories that conduct medical testing and is well-suited for any laboratory that performs quality testing, including clinical, analytical, diagnostic, and forensic laboratories.
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ISO 15189 Overview
ISO 15189 outlines requirements for inspection of the medical laboratory setting prior to and during operation. Inspections should be carried out using a checklist to ensure that all necessary areas of the operating environment have been examined and any discrepancies or potential risks are identified and addressed before testing begins. This type of regulate exercise ensures that all areas of the laboratory meet safety and quality requirements, and no compromising steps are taken in the testing process.
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Inspection Process
For any medical laboratory, one of the most important requirements is for the documentation of processes and results. In order to comply with ISO 15189, laboratories should standardize and document all practices, tests, analysis, and quality control. This is necessary for facilitating traceability and transparency when examining results, and can help ensure that mistakes are not made. Quality control documents should also be created to enable appropriate review and monitoring of results.
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Laboratory Documentation
ISO 15189 is based on the concept of continual improvement, which requires a laboratory to strive to always enhance and develop the quality of its practices and results. This standard outlines the importance of this concept and how a laboratory can implement ways to achieve continual improvement through regular review of its methodology and processes. A laboratory should also engage with external experts to assess and suggest improvements that can be made to the laboratory's practices.
ISO 15189: setting the gold standard for lab quality.
Continual Improvement
ISO 15189 also encompasses requirements for competency and education within the laboratory setting, which includes providing adequate training for employees so that they are equipped to conduct their testing accurately. Good laboratory management practices should also be in place, such as having a Laboratory Quality Manager (LQM) with specialized qualifications, as well as scheduling regular staff meetings to collaborate and discuss any emerging issues.
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Overall, ISO 15189 is an important standard that provides guidance to medical laboratories, helping them to remain compliant with regulations while providing consistent and reliable results. Through the inspection process, regular documentation, continual improvement, and competent staff, a medical laboratory can ensure that it is operating to the highest quality and standards.