Supplier Performance of "non-key" Supplier

S

svijayc

Hello,

I am a newbie to the elsmar forum and I would appreciate any help I can get.

I am a quality assurance lead in a small startup medical device company (< 15 employees) and we are ISO 13485 certified and we are trying to document supplier performance.
We have an approved supplier list which contains suppliers of key components we will track their performance.

We also buy off the shelf products that are not key components from any supplier that can provide us the part. These suppliers are not part of our approved supplier list. I was wondering if we need to track the performance of these supplier as well.

Thanks for all the help

Regards
Shubha
 
S

svijayc

Hello Phil,

Thanks for the reply. We are a virtual manufacturing company so all of our sourcing is done via a contract manufacturer. For parts of our system that are essential to the working of our system we fix suppliers and force them to buy it only from them but for some other material like shipping supplies etc the contract manufacturer will buy from any supplier they deem fit. We define them as class II suppliers.

These class II supplier are not part of our approved supplier list.

I was wondering if there is an ISO requirement to track the performance of these "Class II" suppliers?

Thanks
Regards
Shubha
 

Stijloor

Leader
Super Moderator
Hello Phil,

Thanks for the reply. We are a virtual manufacturing company so all of our sourcing is done via a contract manufacturer. For parts of our system that are essential to the working of our system we fix suppliers and force them to buy it only from them but for some other material like shipping supplies etc the contract manufacturer will buy from any supplier they deem fit. We define them as class II suppliers.

These class II supplier are not part of our approved supplier list.

I was wondering if there is an ISO requirement to track the performance of these "Class II" suppliers?

Thanks
Regards
Shubha

What impact do these Class II suppliers have on your product/service and subsequently on your customers?

Stijloor.
 
S

svijayc

the impact is minimal since their performance is tracked by our contract manufacturer. These "Class II" supplier are not part of our Approved supplier list.


Thanks

Regards
Shubha
 

Marcelo

Inactive Registered Visitor
Hello Shubha and welcome to the Cove.

As the manufacturer, you have the responsibility of ensuring the safety of your medical device.

Regarding suppliers, you told us that the performance isminimla, but did you make a risk analysis of the components to state and back up this? The suppliers are only "non-key" if you determine, using risk management or other established procedure, that they really "non-key". Also, even if your contract manufacturer "tracks" it, it might be that your contract manufacturer does not take into account your responsibilitires regarding the safety of the final product.

There´s been a lot of discussions lately of the relationship of medical device manufacturers and supplers. Onde that is "live is this: http://elsmar.com/Forums/showthread.php?t=37024.

You will find others using the search function.
 
S

svijayc

We have done risk analysis to identify "key" components and "non-key" components. Supplier of "key" components go on our approved supplier list and suppliers of "non-key" components are deemed Class II suppliers.

Since we work in a virtual manufacturing enviornment, the contract manufacturer who is also ISO 13485 certified sources material for us. For "non-key" components the contract manufacturer purchases items from suppliers they deem fit.

I will look at the other threads for answers

Thanks
 
A

Arie0712 - 2010

Hi Shubha

The former replies are correct.
I would just add the following:
You can track or audit the performance of your manufacturer in order to verify its control on his suppliers (regardless to the fact of which product they suggest - of course it is may be more important for 'make' products).

In general, I would suggest you to track the performance of 'off the shelf' items as well.

Arie:)
 
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