What falls under the 'Customer Property' according to ISO 13485:2016

Christie

Regulatory Affairs
#3
Thank you Marc!

As our company manufactures Sutures and Mesh; What can I include while making SOP on "Customer Property" (Supplier Agreement and Certificates, Supplier Self Assessment Reports, Artwork and Labels demanded by Customers).
What else I am missing here?
 

Edward Reesor

Trusted Information Resource
#4
Here's an example I have experienced: You say you manufacture sutures and mesh. You have a customer that would like to have it integrated into one of their kits/products and your company is willing and has the means to package it for them. They send their parts to your company and you provide the final packaging and labeling to have the final configuration sent back to them. Their material and products has to be isolated (so not to be mixed in with other products) and cared for using the same quality system as you use for your own products.
 

Christie

Regulatory Affairs
#5
Here's an example I have experienced: You say you manufacture sutures and mesh. You have a customer that would like to have it integrated into one of their kits/products and your company is willing and has the means to package it for them. They send their parts to your company and you provide the final packaging and labeling to have the final configuration sent back to them. Their material and products has to be isolated (so not to be mixed in with other products) and cared for using the same quality system as you use for your own products.
Thanks Edward! There's no case like this.

So, Can I just add these (Supplier Agreement and Certificates, Supplier Self Assessment Reports, Artwork and Labels demanded by Customers) to Customer Property?
 

Edward Reesor

Trusted Information Resource
#6
I have a separate folder for Supplier Agreements with specific suppliers as sub folder within the Quality System folder. This also contains their own quality certificates (their own 13485 certs, for example) as I find it easier to track expiration dates for certifications during my internal audits. For customers, I also have a separate folder with all the relevant information (labels, artwork, etc) in the Technical File for the specific device. I hope this helps.
 

Al Rosen

Staff member
Super Moderator
#7
I don't consider supplier agreements and copies of ISO certs as customer property. Supplier agreements are your contracts. Copies of ISO certs are external documents. Customer property is owned by your customer. For example, material provided by your customer to be used in your product to be delivered to the customer or product returned for evaluation or repair.
 

yodon

Staff member
Super Moderator
#8
It may well be that you have no customer property that falls under this (I agree with @Al Rosen regarding agreements and such). Does your customer give you anything that requires your custodial care? Other examples might include a label printer, a special gage, a computer, maybe even some special documentation.
 

Tagin

Trusted Information Resource
#9
I agree with Al that the items listed are not 'customer property' in the ISO sense. They may be covered, though, in different sections of 13485, depending on the specific contents of the documents:
  • Supplier Agreement and Certificates - 4.2.3,4.2.4, 4.2.5, 7.2.1
  • Supplier Self Assessment Reports - 8.2.1, 4.2.5
  • Artwork and Labels demanded by Customers - 4.2.3,4.2.4, 4.2.5, 7.5.1e
Note, for example, that if the customer instead provided the physical labels, then that would be customer property.
If they instead provided, say, a silkscreen stencil for your company to use to make labels, that would be customer-supplied tooling.
 

Marc

Fully vaccinated are you?
Staff member
Admin
#10
If they instead provided, say, a silkscreen stencil for your company to use to make labels, that would be customer-supplied tooling.
The label design would probably fall under customer intellectual property as well since the customer provided the design.

Edit add: My ex- worked for a company which printed labels, boxes, etc. The customer provided the artwork and as such was the customer's property.
 
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