Supplier or outsourced? Medical Device installation, sales, training

K

Kuhalit

#1
Good morning:

For medical device:

If you have Service Provider for Installation, sales, Training of customer, 1st Level Support:

Is this Outsourcing or just purchasing a supplier
7.4 or 4.1?

What is the Definition, what is easier to handle?

Please discuss and make suggestions (or what is the MUST??)

And, by the way, do you "risk manage" every outsource process? (must or may)?

Thank you!
 
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sagai

Quite Involved in Discussions
#2
That's pretty much outsourced for me and of course your are purchasing and they are suppliers. My recollections is that the liability for these are on the Manufacturer regardless someone else does the work itself.
One extreme exception would be if you only buy the time of the people on a time and material, etc. basis.
Cheers!
 

harry

Trusted Information Resource
#3
......................... If you have Service Provider for Installation, sales, Training of customer .......................
Let's take 'training of customer' as an example. The training supplier is the party you outsourced your 'training of customer' process to.

One of the ways that you control your outsourcing of the 'training of customer' process is by evaluating your training supplier to make sure that they meet your requirements.
 
K

Kuhalit

#4
Thank you for answering:

OK, I try again, maybe my Explanation wasn't good.

For me, according to purchasing a supplier is treated per 7.4.
I can choose one with or without QM-System certificate and I do whatever I think, I Need to ensure the Quality of the delivered product.
Actually, he can do it according to his procedures if he owns a QM-System.
OR He has None, then he must use my procedures.


BUT if I outsource a process to someone. this is different. Because: He shall work UNDER MY QUALITY SYSTEM. He must do the Trainings as I do, and the Installation and the sales. He will get all the procedures.

Actually I am confused.
What is the difference between "Purchasing" 7.4 and 4.1 Outsourcing??
 

sagai

Quite Involved in Discussions
#5
Let's put my thoughts one by one.


For me, according to purchasing a supplier is treated per 7.4.
Yes!

I can choose one with or without QM-System certificate and I do whatever I think, I Need to ensure the Quality of the delivered product.
Yes, product or service, agree!

Actually, he can do it according to his procedures if he owns a QM-System.
Question ... of what they can do?
the product/service that they provide you? Yes!

OR He has None, then he must use my procedures.
Nope man!
It is a common confusion I think. Please do not intimidate another business entity with your QMS unless they volunteer to do so!


BUT if I outsource a process to someone. this is different.
nope.
i do not think if it would be different.

Because: He shall work UNDER MY QUALITY SYSTEM.
Nope, not at all.

He must do the Trainings as I do, and the Installation and the sales. He will get all the procedures.
Nope, I would not suggest again to enforce your qms to others.
What you actually do need is to set your expectation on the product/service and other things including quality goals as well. It is mostly determined in a statement of work.
The other bit is to consider is in order to make sure that they complies with the expectation you have set, the common approach is to audit them on a regular basis.

What is the difference between "Purchasing" 7.4 and 4.1 Outsourcing??
Purchasing is a general approach you do purchasing whereas outsourcing is a business layer on it when certain compulsory regulatory relevant process outsourced to third party.

hope it helps.
Cheers!
 
K

Kuhalit

#6
OK. Thank you. Doesnt FDA requires to give Installation spec (e.g.) to your reseller, who does Installation?
 
M

MIREGMGR

#7
FDA has no specific requirement for what specs you provide to parties that are part of your sales/distribution channel. FDA however regards you as responsible for whatever those parties do in regard to sales, delivery and installation. You have full responsibility for your device's safety and effectiveness as it is used clinically. Thus it will be to your benefit to provide whatever specs or other controls are appropriate to assure that installation occurs as you determine it should.
 
#8
Actually I am confused.
What is the difference between "Purchasing" 7.4 and 4.1 Outsourcing??
Thinking of difference between this and that will confuse you, for the 4.1 and the 7.4 are not set to explain any differences.
When you outsource any process, you are purchasing (Evaluating and selecting a agency to whom you can outsource, defining the criteria technically and commercially, providing necessary outsourcing information, ... and such per the 7.4)
If I am doing the installation, sales and training as a part of my organization process till today and going further wish to get this services from outside of the organization, I am thinking purchasing and applying the needed controls on the agency who is providing these services such that what is provided (outsourced) is as good as my organization executing it.
 
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