The intent of right-sizing your Quality Management System (QMS) is to be compliant but not overly burden your organizational resources and to keep it simple and flexible to meet the product and maturity of the company. This discussion will share how to build a “right-size” QMS to meet regulatory and customer requirements, prepare for device submission, or as part of continuous improvement. This discussion will share the good, bad, and ugly of what, why, when and how to implement your QMS.
- Conceptualize the benefits of a QMS and when it has been sized to your company’s needs [One Size Does Not Fit All]
- Identify QMS foundational elements and the implementation process [Pillars for Success]
- Understanding how your QMS can still be compliant and not have everything implemented [Evolution of the QMS]
- Evaluate common challenges and how to avoid them when developing and implementing your QMS [QMS Obstacles]
- Engage with people who have implemented QMS “right-sizing” successfully [Case Study(ies)] – not sure if we can get someone from industry on panel
- Ensure you are understanding and planning for both FDA QMSR and ISO 13485 [Forward Thinking]