Advisory Notices - ISO 13485

A

amejel

#1
I'd like to extend my gratitude to the founding and contributing members of this forums as this is my first post. Please excuse me if I've posted this in the wrong section.

I work for a small company that offers metal finishing operations namely for knee/joint replacements' polishing. We receive cast-in parts, we polish them and then we send them back to our clients (the manufacturers). One of our client has recently requested our company to be certified ISO 13485 to maintain the continuity of the business.

My question has to do with the advisory notice (7.2.3 d) ). Our company does not design, nor commercialize any products (That is the entire responsibility of the client). We only offer to outsource the polishing phase of the manufacturing.

My understanding that the advisory notices deal with customer communication related to any future modification that might occur to the product when it is out there in the market. Our client does that since it commercializes its knee parts.

So from that, I believe that I can claim an exclusion on 7.2.3 d) and systematically on bits of 8.5.1 (Procedure relating to advisory notices).

I'll be more than happy to supply more information for those who want to help if it makes it any clearer.
 
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Ajit Basrur

Staff member
Admin
#2
Your understanding is perfectly correct :)

However, there is no exclusion and your role as a subcontractor is to support any investigation that could be required on the medical device and your procedure shall state the responsibility of Advisory Notices rests with the customer who is responsible for placing the device on the market.

I suggest you to take a look at ISO 14969 as well for clarity.

Refer to some threads we have on this subject -

http://elsmar.com/Forums/showthread.php?t=18270

http://elsmar.com/Forums/showthread.php?t=19306

http://elsmar.com/Forums/showthread.php?t=10540
 
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