Hi, this is my first post.
I working for a company that was buyed by a Multinacional.
We make plates for IVD.
The Multinacional has the customer service and sales department, and we only produce whatever the Multinacional wants.
Then, we manufacturing the product with our quality system (9001-13485) for the factory and they sell the products to customer with other quality system (9001)and diferent places.
Who is the responsible of the emission of advisory notices to the customers? Who for notifications?
Can we introduce the procedures in our systems to meet the standard while sales department do the work?

Thanks a million

Welcome :bigwave:

We had discussed this earlier - Advisory Notices - Who is responsible for dealing with Advisory Notices? (http://elsmar.com/Forums/showthread.php?t=19306)

If you feel this has not answered your query, pl come back with fresh questions :)

Thanks Ajit. I read this before.
If I can understand, the commercials will implement the notices and notifications, because they really put the device in the market.
But we are the same company. My company was bought one year ago.
The scope is different for both systems.
ISO 13485 says that: The organization "shall" stablish documented procedures for the issue and implementation.
This force us to do all this work or we meet this points just with the exchange of information between us?

Thanks again

I think this depends on whether you are now, after being bought, only a manufacturing facility of the multinational mother company (looks like it) or you are an independent branch under that company, and also how the multinational company and your facility are organized. It is more an internal decision.

Hi Atila73,

In my opinion, you, as a manufacturing facility may issue advisories associated with your product to your mother company with a note that these further need to be issued to the customer/s.

And as Treesei has said, "it is more an internal decision", and will largely depend on your system of internal communication as well as customer communication.

Thanks a million for all.
We decided they send the communications and we make the investigations.
I think that is ok because we have a really good communication system.