Approved Vendor (Supplier) List Issues - Class II medical device maker

[DonkeyKong]

Does anyone have a feeling on Approved Vendor issues with the new QSR FDA regs?....I was wondering if it fell along the same lines as the ISO 2000 standard where you keep documents concerning "vendor approval/audit" and a "approved vendor list". Are the FDA requirements much, much more stringent?....I am in a battle at work right now trying to simplify our system.....

We are a class II medical device maker of medical device items..

Any help would be much appreciated.

Thanks,
DK

[RosieA]

I am no longer in the Medical Devices world, but when I was three years ago, there were no differences between how I dealt with the approved supplier requirement as an ISO issue and as a CGMP issue. I never had any FDA comments or findings on it either.

Is there something specific (like wording) triggering your question?

[Aaron Lupo]

DonkeyKong said:

Does anyone have a feeling on Approved Vendor issues with the new QSR FDA regs?....I was wondering if it fell along the same lines as the ISO 2000 standard where you keep documents concerning "vendor approval/audit" and a "approved vendor list". Are the FDA requirements much, much more stringent?....I am in a battle at work right now trying to simplify our system.....

We are a class II medical device maker of medical device items..

Any help would be much appreciated.

Thanks,
DK

With the new FDA regs?

If you look at 820.50

3) "Establish and maintain records of acceptable suppliers, contractors and consultants."

Now does it say you need an approved suppliers list, no but I think it would make it a heck of a lot easier on the people in the company if you did have a list so they know who they can order from. Just a thought.