AVL (Approved Vendor List) Supplier Listing - ISO 13485 Requirements

T

TNHunter

#1
My reading of ISO13485:2003 para. 7.4.1 is that we shall evaluate and select suppliers but that an approved vendors list (AVL) in not required. Definately a good thing to have but not required.

We define our suppliers as either class 1 or class 2 depending on the impact to the product/processes and only require class 1 to be listed on our AVL. In doing this, we feel that we meet both the intent and the requirement of 7.4.1 and our registrar has not found a problem with this.

But one of our customers insists that ALL suppliers,(even down to the local Wal-Mart) be included on the AVL because if not, we cannot control the "product" quality.

Example, cited soap used in the bathrooms. If not on AVL, cannot guarantee that "product procured" will not impact manufacturerd product.

No amount of talking will change this auditors opinion on this. :mad::mad:

Anybody else ever have this experience with AVL's and supplier approvals?
 
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Stijloor

Staff member
Super Moderator
#2
This customer (?) auditor must be sent back immediately to audit school. Your response should be NO. Period. It does not make sense to put a toilet paper and pencil supplier on the AVL (as you call it) list.

Good luck!

Stijloor.
 
D

DrM2u

#3
But one of our customers insists that ALL suppliers,(even down to the local Wal-Mart) be included on the AVL because if not, we cannot control the "product" quality.
You are correct in your interpretation of the ISO 13485 requirements and, having an AVL, you have gone beyond the requirements.

Since the issue seems to be a 'customer' specific requirement, ask if this is a cusotmer's requirement or his. If it is a customer's requirement then challenge the auditor to document such a requirement in their Supplier Quality Manual (or the equivalent) with detailed interpretations of the requirements, and you will be more than happy to abide by their requirements (if the business warrants it, of course). If the auditor states that it is HIS requirement then challenge him to establish if meeting his specific requirement is more important than having a mutually beneficial relationship. Challenge him from a business perspective without threatening not to do business with them. As a last resort you can go above his head to his higher-ups and challenge his qualifications, expectations and interpretations. Maintaining a good and profitable business relationship is more important than apeasing an auditor, IMHO.
 

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wayne.wilson7

Involved In Discussions
#4
ok i would like to throw another spanner into the works. I have had a minor raised against our approved lisiting. I am only showing suppliers for Materials, Tooling and Gauging at present do i also need to show the people we use for machine maintenance?
 

wayne.wilson7

Involved In Discussions
#5
Since completing my senior audit course it has given me more confidence to challenge my external auditors.

I believe you need to challenge this which looks like you laready have, if still he insists i would challenge above and request for a new auditor.

I have requested twice in the past to change auditors so i can get a fresh angle to look at our system.

good luck.

My reading of ISO13485:2003 para. 7.4.1 is that we shall evaluate and select suppliers but that an approved vendors list (AVL) in not required. Definately a good thing to have but not required.

We define our suppliers as either class 1 or class 2 depending on the impact to the product/processes and only require class 1 to be listed on our AVL. In doing this, we feel that we meet both the intent and the requirement of 7.4.1 and our registrar has not found a problem with this.

But one of our customers insists that ALL suppliers,(even down to the local Wal-Mart) be included on the AVL because if not, we cannot control the "product" quality.

Example, cited soap used in the bathrooms. If not on AVL, cannot guarantee that "product procured" will not impact manufacturerd product.

No amount of talking will change this auditors opinion on this. :mad::mad:

Anybody else ever have this experience with AVL's and supplier approvals?
 
S

silentrunning

#6
Is it really worth alienating a customer over this? Myself, I would demonstrated that this is NOT an ISO requirement, but if the customer wants it I will provide it. It's not that big of deal. We also use the 2 tier system and have EVERY entity that gets paid by us on the second tier. Even the county tax collector. It's all done in the computer anyway so it's not any more work. How important is customer satisfaction to you?
 

somashekar

Staff member
Super Moderator
#7
Is it really worth alienating a customer over this? Myself, I would demonstrated that this is NOT an ISO requirement, but if the customer wants it I will provide it. It's not that big of deal. We also use the 2 tier system and have EVERY entity that gets paid by us on the second tier. Even the county tax collector. It's all done in the computer anyway so it's not any more work. How important is customer satisfaction to you?
I would say here not to have too hard an approach nor a too soft approach to the AVL. We are talking about 13485 system, about medical devices and the associated cleanliness, health and hygiene of the people handling the devices, work environment monitoring, contamination control and perhaps any hand washing procedures, cleanroom gowning, Laminar flow benches and its filters etc etc and many more ... that has a significant impact on the product quality and meets international standards.
Certainly a good risk assessment when done can map a supplier evaluation and selection as a criteria to mitigate the risks involved with products purchased that have a bearing on the risk.
Now coming to the soap stuff in bathroom, if it is provided as a employee facility for hand cleaning as a routine after work, then I prefer to keep it out. However if you expect the employees to handwash using that soap and then get to the work bench with a specific reason., then the soap source is specific to me to be evaluated and selected and put into the AVL based on requirement.
It is good to question yourself on this line, and then if convinced to you as a stuff which can be out of your AVL, frankly ask the customer auditor why you must include and how this will improve the product quality ~~~
 
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