Quality Management System – Work Smarter Not Harder

As we all know if you sell a medical device in the US you need to have a QMS. But….that doesn’t mean your SOPs must regurgitate 21 CFR 820 and implement vague SOPs leaving everyone scratching their heads trying to figure out what they are supposed to do. This type of QMS will only lead to confusion and compliance gaps.

Your QMS should fit your device needs and document what you do. Don’t try to squeeze your QMS into a system that doesn’t work for you.  Its best to build your QMS to fit what you need. What I mean by this is:

• If you use contractors for most of your services, then document in your Quality Manual what parts of 820 apply to your QMS and what parts do not. 

• Set realistic KPIs that are measurable.  Don’t set KPIs such as “reduce complaints by 25% each year”. This may lead to a compliance gap because if you don’t meet that goal then you are not following your Quality Manual.

• If your device is a single use wound dressing you wouldn’t need an SOP for installation and servicing. Just explain in your QM that these sections don’t apply.

• If your process doesn’t follow your SOP, then change your SOP to document what you really do and train the staff on the updated SOP.

Remember your QMS is a living system that is meant to be updated. A QMS is not a “set it and forget it” system.