Licensee as a Supplier on the ASL

#1
In an internal audit conducted by a consultant, we got a major NC for not listing the licensee as a supplier on the ASL. As we do not purchase goods or services from the licensee, we don't consider them a supplier. Under ISO 13485, is this a correct assumption? The licensing agreement is governed separately under a legal agreement and in fact, we don't pay them.
 
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#3
No - not at all. The licensee came up with formulations and then essentially, gave the recipe to us to make for commercial distribution.
 

Ajit Basrur

Staff member
Admin
#4
No - not at all. The licensee came up with formulations and then essentially, gave the recipe to us to make for commercial distribution.
So the licensee does provide "service" - was this a one-time or would the licensee be involved on an ongoing basis?
 

Ajit Basrur

Staff member
Admin
#6
So the licensee provided the start up "recipes" and maybe once every 2-3 provides another. Definitely on an infrequent basis.
Definitely not a Major NC.

ISO 13485 requires "Records of the results of evaluation, selection, monitoring and re-evaluation of supplier capability or performance and any necessary actions arising from these activities shall be maintained" and maintaining an ASL is not mandatory. Take a look in your Purchasing procedure and the exact verbiage around what type of suppliers need to be in your ASL.
 
#7
Definitely not a Major NC.

ISO 13485 requires "Records of the results of evaluation, selection, monitoring and re-evaluation of supplier capability or performance and any necessary actions arising from these activities shall be maintained" and maintaining an ASL is not mandatory. Take a look in your Purchasing procedure and the exact verbiage around what type of suppliers need to be in your ASL.
Thanks for your input. Helpful
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#8
Wow. a Major for that?
Was it major on its own or was it part of a group of findings in the same subject area/element?
 

Ronen E

Problem Solver
Staff member
Moderator
#9
No - not at all. The licensee came up with formulations and then essentially, gave the recipe to us to make for commercial distribution.
Just yo clarify, I think that that entity is a "licensor" (one who gives a license) rather than a "licensee" (one who received a license). Of course, that terminology doesn't affect the adequacy of the answers given.
 
#10
Wow. a Major for that?
Was it major on its own or was it part of a group of findings in the same subject area/element?
The internal auditor (who was a longtime consultant to the organization) gave us a major on that alone. We argued with her about it since the circumstances had been the same for 8 years (to the beginning of our certification). So far today, we are doing good with the ISO auditor.
 
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