Product not in the Registration Scope of a Critical Subcontractor/Supplier

Hi everyone! I have a question regarding our sub-manufacturer. They are ISO 13485 certified, however at the time they were certified they were not manufacturing our product, thus in the second page that says "Scope" our specific product is not included.

How important is this regarding our own regulatory conformity? Do we need them to be specifically ISO certified for manufacturing our specific product?

Thanks for your insight!

jennaleeb said:

Hi everyone! I have a question regarding our sub-manufacturer. They are ISO 13485 certified, however at the time they were certified they were not manufacturing our product, thus in the second page that says "Scope" our specific product is not included.

How important is this regarding our own regulatory conformity? Do we need them to be specifically ISO certified for manufacturing our specific product?

Thanks for your insight!

Click to expand...

Does the scope contain a type of product that yours would fall under, or are you expecting to see your specific product cited?

The product does not fall under a type of product in the scope. I am wondering if this is a red flag.

jennaleeb said:

The product does not fall under a type of product in the scope. I am wondering if this is a red flag.

Click to expand...

Can you help us by telling ...
1. What medical device he makes for you
2. What is his scope on his ISO13485

Hmm perhaps this is a question for our regulatory consultant who can look at the manufacturer's ISO certificate and knows our product well. I was more wondering if this was a problem other people had run into?!

jennaleeb said:

Hmm perhaps this is a question for our regulatory consultant who can look at the manufacturer's ISO certificate and knows our product well. I was more wondering if this was a problem other people had run into?!

Click to expand...

We don't know what the problem is yet - you haven't given enough info.

Certainly it could be a significant issue for you, to be fixed by the supplier working with their NB to get their certificate scope extended.

In the meantime it's as if your supplier is not ISO 13485 certified for the device/item/material they supply to you, thus you would control them more comprehensively.

jennaleeb said:

Hmm perhaps this is a question for our regulatory consultant who can look at the manufacturer's ISO certificate and knows our product well. I was more wondering if this was a problem other people had run into?!

Click to expand...

Its something like chicken or egg first ...
He became your sub-manufacturer because he has ISO13485 with a scope you think covers your product type ~~~
OR
He became your sub-manufacturer because he has ISO13485 and now you are looking into his scope to see if your product type is being covered ~~~
The later, if true, is risky to your sub-manufacturer selection approach, and will have regulatory implications.
Kindly help us with a reply to post #4 ...
Thanks

Jennaleeb
As this a subcontractor they do not necessarily need to be ISO 13485 certificated, as mentioned in other posts, it all depends on what they are doing for you .i.e sterilization, packing, complete manufacture etc. Can you clarify?

Hi everyone - I appreciate the help. I am new to my position (I am a recent grad working at a small start-up) and I think everyone will understand my hesitation to divulge things on the internet before I discuss it with the team. Your responses have definitely raised some concerns that I need to follow up on.

Thank you again for your help! The Cove has been an INFINITELY valuable resource for me.