Medtech Magazine: Is an overly burdensome QMS self-imposed?
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TL;DR: Organizations often develop overly complicated Quality Management Systems due to internal issues like skepticism toward regulations, misunderstanding requirements, and lack of employee input. The article suggests leadership involvement and process owner engagement in procedure development. The article investigates whether organizations inadvertently create unnecessarily complex Quality Management Systems (QMS). It posits that internal factors frequently contribute to this issue, including a skeptical perception of regulatory requirements, inadequate understanding of those requirements, and insufficient input from employees directly involved in daily operations. To address this, the.
Key takeaways
- The article investigates whether organizations inadvertently create unnecessarily complex Quality Management Systems (QMS)
- It posits that internal factors frequently contribute to this issue, including a skeptical perception of regulatory requirements, inadequate understanding of those requirements, and insufficient input from employees directly involved in daily operations
- To address this, the article advocates for demonstrable commitment from senior leadership, including CEO participation in quality and regulatory training
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