Covering an acquired company in our ISO 13485 certification

S

SGquality

Quite Involved in Discussions
A quick question on ISO 13485 certification:

My company (an ISO 13485 certified) acquired another medical device design company (also ISO 13485 certified) and both our certification bodies are different.

Need your advise on the following questions:

1. Though we acquired this company, the financials are not aligned and both are operating as individual companies, and may be another 2 years before merging under one umbrella. In this scenario of different operating companies, can we take this new company under our ISO certification prior to merging them financially?

2. How do we approach certification bodies with this request?

Thank you as always :agree:
 
Ronen E

Ronen E

Problem Solver
Moderator
SGquality said:
1. Though we acquired this company, the financials are not aligned and both are operating as individual companies, and may be another 2 years before merging under one umbrella. In this scenario of different operating companies, can we take this new company under our ISO certification prior to merging them financially?
Click to expand...

Finances are irrelevant. In my opinion you can either keep running under two separate certifications, or merge under your certification if you also align the two QMSs.

SGquality said:
2. How do we approach certification bodies with this request?
Click to expand...

When you are ready to consolidate, just notify the purchased company’s CB that you wish to drop (not renew) their certification, and coordinate with your own CB to have the extended certification (covering both companies) processed and issued prior to that discontinuation.
 
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