Ownership of ISO 13485:2003 company changing - Anyone to update?

R

rthompson

Starting to get Involved
#1
#1
Greetings All,

The ownership of our ISO 13485:2003(with CMDCAS) and FDA registered establishment will be changing very soon. All else will remain the same including the facility location, QMS, QM, employees, etc. Only the companies tax ID # (EIN) will be changing.
Do I need to notify our registrar?
Has anyone gone through a similar transition?
The management and all employees are remaining in place so there is nothing about this change that would affect quality.
I know this is somewhat of an unusual question and I thank you all in advance for any assistance.
Best,
Rob
 
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A

achorste

#3
#3
We went through a similar change at my last company - the only changes to the QMS were documentation headers etc (and Quality Policy in line with our new parent company). We did inform our registrar who (for a fee) changed our ISO certificates.

Everything went on as normal :D
 
B

brandomenon

#4
#4
achorste said:
We went through a similar change at my last company - the only changes to the QMS were documentation headers etc (and Quality Policy in line with our new parent company). We did inform our registrar who (for a fee) changed our ISO certificates.

Everything went on as normal :D
Click to expand...
Since you mentioned CMDCAS and the above post talks about a new ISO certificate I thought I would also mention that you would need to send a copy of the new ISO cert to Health Canada under section 43.1 of the CMDR.
 
D

Doug Tropf

Quite Involved in Discussions
#5
#5
Check the contract you have with your registrar to see if there are notification requirements. I believe you must notify the FDA within 30 days by completing form FDA 2891.
 
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