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Site removal from MDSAP multi-site Certificate

#1
I have a multisite MDSAP cert where one site is a Legal Manufacturer and the other sites are supporting outsourced tasks, such as design & development, manufacturing, storage & distribution.

I am wondering, what happens when I decide to remove a site from the MDSAP Cert because we no longer perform the tasks or another site adopts the workload; for example a storage & distribution is contracted out to a 3rd party logistics company or two separate manufacturing sites combine into one.
What actions are triggered when sites are removed from the existing scope? How do we show or do we need to show that the site that was providing certain outsourced tasks is no longer needed because....
 
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somashekar

Staff member
Super Moderator
#2
I have a multisite MDSAP cert where one site is a Legal Manufacturer and the other sites are supporting outsourced tasks, such as design & development, manufacturing, storage & distribution.

I am wondering, what happens when I decide to remove a site from the MDSAP Cert because we no longer perform the tasks or another site adopts the workload; for example a storage & distribution is contracted out to a 3rd party logistics company or two separate manufacturing sites combine into one.
What actions are triggered when sites are removed from the existing scope? How do we show or do we need to show that the site that was providing certain outsourced tasks is no longer needed because....
Its a change.
A planned change.
As a part of the plan, informing your change plan to the CB must be included and allow them to ask more questions.
You may end up with a mid term scope change audit or the change is considered in the annual survelliance audit.
Have you taken up these with your CB ?
 
#3
Thank you for a prompt reply. I haven’t talked to my CB. Wanted to get an idea before proposing the change to plan for a least disruptive/costly change- i.e. to avoid an extra audit! Any specific criteria that would trigger a mid term audit or how to avoid it?
 

somashekar

Staff member
Super Moderator
#4
Thank you for a prompt reply. I haven’t talked to my CB. Wanted to get an idea before proposing the change to plan for a least disruptive/costly change- i.e. to avoid an extra audit! Any specific criteria that would trigger a mid term audit or how to avoid it?
The type of change you are suggesting would need a series of activities and a well made risk management plan for the change implementation. This way, you will be maintaining the integrity of the quality management system, when changes to the quality management system are planned and implemented. (see ISO 13485:2016 .... clause 5.4.2)
If the plan is such that the changes comes into force thru your planned actions, a month or two before your survelliance audit, you could indicate the same in your CB communication and direct the audit planning to consider the change in the upcoming survelliance. It's up to you and your CB to jointly assess and agree that the way to go forward is by considering scope change in survelliance audit period. Make sure that this is in line with your business requirements as well. Good Luck...
 
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