Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

All,
The branch of the company I currently work for is 13485 certified, has CE marked products, and is FDA registered. This facility relies on contract manufacturing for our commercial products and provides, among other things, customer service, order entry, product shipment, etc. to our users in the field. The corporate office has been downsizing some departments as part of an ongoing cost containment effort, and the next target for reduction appears to be the elimination of our customer service department at this facility, with responsibilities potentially shifted to the corporate office which is located in another state. After review of the criteria for reporting a 'substantial' change to our notified bodies, it appears as though this departmental elimination would qualify as a significant impact on our current facility QMS since it (a) affects complaint handling, contracts and customer orders, product returns, shipping, traceability, etc., and (b) changes the composition of the QMS that was originally assessed and certified, all of which appear to be required to be reported to our Notified Body.

My questions are as follows:
1. Am I correctly interpreting the substantial change criteria for our situation based on your collective experiences?
2. Has anyone else in the forum encountered a similar situation? If so, what was your experience with how the notified body handled the situation (subsequent audit of the location of the transferred responsibilities, audit of the remaining facility now that the scope of the QMS has changed from the original certification, other actions)?
3. What internal activities and / or documentation (outside of the required QMS documents) did you undertake to support this change and the subsequent alteration to the facility's QMS?

Thanks in advance for your input and expertise!

This message was posted by a user wishing to remain anonymous

Most companies work on the same QMS system; if your company is indeed working on the same QMS system, the changes that you are discussing while deemed significant are not going to incur significant work from your end. In fact, if your headcount has reduced, you could be in line for reduction in audit days and hence, cost. Regardless, when in doubt, always report changes to your Notified Body. The worst they can do is disagree with your assessment of change being insignificant.
Original Message:
Sent: 22-Mar-2017 11:47
From: Anonymous Member
Subject: Notifications to Notified Bodies on QMS changes

This message was posted by a user wishing to remain anonymous

All,
The branch of the company I currently work for is 13485 certified, has CE marked products, and is FDA registered. This facility relies on contract manufacturing for our commercial products and provides, among other things, customer service, order entry, product shipment, etc. to our users in the field. The corporate office has been downsizing some departments as part of an ongoing cost containment effort, and the next target for reduction appears to be the elimination of our customer service department at this facility, with responsibilities potentially shifted to the corporate office which is located in another state. After review of the criteria for reporting a 'substantial' change to our notified bodies, it appears as though this departmental elimination would qualify as a significant impact on our current facility QMS since it (a) affects complaint handling, contracts and customer orders, product returns, shipping, traceability, etc., and (b) changes the composition of the QMS that was originally assessed and certified, all of which appear to be required to be reported to our Notified Body.

My questions are as follows:
1. Am I correctly interpreting the substantial change criteria for our situation based on your collective experiences?
2. Has anyone else in the forum encountered a similar situation? If so, what was your experience with how the notified body handled the situation (subsequent audit of the location of the transferred responsibilities, audit of the remaining facility now that the scope of the QMS has changed from the original certification, other actions)?
3. What internal activities and / or documentation (outside of the required QMS documents) did you undertake to support this change and the subsequent alteration to the facility's QMS?

Thanks in advance for your input and expertise!