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Supplier Approval of electronic document storage service

B

bobbyv

#1
Hi All,

If we use a network or cloud based storage provider to store our quality system documentation and records such as Sharefile or Sharepoint for example, are they considered a "Supplier" under the definition of suppliers in ISO13485?
Do we need to perform supplier selection and supplier re-evaluation processes for them?

Cheers,

Bobbyv:bigwave:
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi All,

If we use a network or cloud based storage provider to store our quality system documentation and records such as Sharefile or Sharepoint for example, are they considered a "Supplier" under the definition of suppliers in ISO13485?
Do we need to perform supplier selection and supplier re-evaluation processes for them?

Cheers,

Bobbyv:bigwave:
A supplier is an entity you pay, and get something in return from.

Unless the network storage is internal (on a server that belongs to you and is maintained by you) I'd say the answers to your questions are yes and yes.

Cheers,
Ronen.
 
B

bobbyv

#3
Hi Ronen E,

The reason I ask this questions is that I understand a "Supplier" to mean any entity that impacts directly on the quality system.
Where does one draw the line with "IT" or "computer" related suppliers? Does this mean that we also need to approve microsoft since we write our quality documents in Word, or Adobe or Dell.....?
Approving "Suppliers" will never end. Surely we have to draw a line in the sand.

cheers,

Bobbyv
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi Ronen E,

The reason I ask this questions is that I understand a "Supplier" to mean any entity that impacts directly on the quality system.
Where does one draw the line with "IT" or "computer" related suppliers? Does this mean that we also need to approve microsoft since we write our quality documents in Word, or Adobe or Dell.....?
Approving "Suppliers" will never end. Surely we have to draw a line in the sand.

cheers,

Bobbyv
I'd dare say that a supplier responsible for the maintenance and accessibility of all (or most) of your quality documentation has a direct bearing on your product quality.

With reference to Microsoft, the bearing is a little less direct. Wherever software like MS Word has a direct bearing on your product quality, the application at your org should be validated. There are "canned" solutions for validating the application of mainstream software - search the Cove for threads on that topic.

About drawing the line - my approach is: where it's not obvious that there's no direct bearing, assume that there is and treat it accordingly.

Cheers,
Ronen.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#7
Ronen already covered your question (usually does)...

Another thing to consider beyond Approving the Supplier is your backup plan...Approved doesn't mean perfect...
Not just software and file backup, but your backup plan for when your Web connection is lost. That's not your cloud host, that's your service provider...

E-Docs are great when you can get at them...but what about when a truck takes out the pole out front and you have no connection?
Depending on your doc count and workflow, a terminal in-house with redundant files can help (and is cheap)...but if you have a low file count anyway, a master hardcopy file can also work.

The way the world is moving, you are required to have safety documents like SDS's available at all times, power or not.
 
B

bobbyv

#8
Hi Ninja,

Agreed!
Usually there is a local copy syncronized to PC as well.
Cheers,

BoobyV
 
M

michajel86

#9
I would say "yes" only in case they are responsible also for maintenance IT and has direct inpact on one of your supporting process (acc. to process map). In such case it is external service that has to be controled by appropriate manner . The selection of external partner has to be done acc. to local laws and its evaluation depends on your QMS . This shall be prescribed in internal documentation - procedures .
You can evaluate for example ,
comunication level ,
user satisfaction .
Response rate ,
"issue solving" period ..etc.
Depends on agreements / contract..:bigwave:
Michal.
 
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