Abstract
Maturity modeling is an old tool that has many uses in establishing an effective and efficient quality management system (QMS) for medical device companies. Using a structured set of levels to measure maturity across multiple categories, it can be used to assess current maturity status and create a roadmap for improvement. There are many scales and categories that can be customized for individual functions/processes or for the overall QMS. Maturity modeling is an excellent tool for process owners to improve process effectiveness and overall results. Maturity modeling and assessment can be used to demonstrate standards of excellence, identify gaps and training needs, create aspirational goals for improvement, and provide a basis for recognition and reward. Additionally, the FDA is currently piloting the use of maturity modeling appraisal as part of their Case for Quality.
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