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"Practical considerations for laboratories: Implementing a holistic quality management system"

A quality management system (QMS) is an essential element for the effective operation of research, clinical, testing, or production/manufacturing laboratories. As technology continues to rapidly advance and new challenges arise, laboratories worldwide have responded with innovation and process changes to meet the continued demand. It is critical for laboratories to maintain a robust QMS that accommodates laboratory activities (e.g., basic and applied research; regulatory, clinical, or proficiency testing), records management, and a path for continuous improvement to ensure that results and data are reliable, accurate, timely, and reproducible. A robust, suitable QMS provides a framework to address gaps and risks throughout the laboratory's workflow that could potentially lead to a critical error, thus compromising the integrity and credibility of the institution. While there are many QMS frameworks (e.g., a model such as a consensus standard, guideline, or regulation) that may apply to laboratories, ensuring that the appropriate framework is adopted based on the type of work performed and that key implementation steps are taken is important for the long-term success of the QMS and for the advancement of science ... (Full article...)
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