Using a Vendor's (Supplier's) Quality System

N

Noblelobo

#1
Hello,

I am new to quality systems. I am working with a start up and my task is to build the quality system.

I am using a software we bought that includes a template of the ISO 13485 and modifying to best fit our company. I have lots of questions, but the one that is at the top of my list is about using a vendors quality system as part of our quality system.

The main component of our device is software. We do not build software, and none of us are computer programmers. We have contracted a company that specializes in creating software for medical device companies. Their quality system appears to be rock solid.

I did some research and asked someone at the FDA if it was ok to rely on a vendor's QS. They said it was ok as long is it was part of our quality system and procedures.

My questions is: Where in the manual or system would I put this? would it be part of the Quality manual itself? or do I put it under a SOP?

I am not sure if this is the correct forum for this thread, so please move if needed.

Thank you,

GR

PS. We are building a mobile telemetry monitor from components that are already approved. We are outsourcing the creation of the software that is going to link everything.
 
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somashekar

Staff member
Super Moderator
#2
Re: Using a vendor's quality system...

Welcome to the Cove Noblelobo .... (GR)
You would simply put the vendor's quality system as one of the controls of your out sourced process as required in the clause 4.1 of ISO13485.
No SOP required here. This can be stated in the manual if you wish to OR detailed within your procedure for purchasing (7.4)
 
Last edited:

somashekar

Staff member
Super Moderator
#3
Re: Using a vendor's quality system...

I have moved this thread to "ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems"
 

yodon

Staff member
Super Moderator
#4
Re: Using a vendor's quality system...

While what Somashekar notes would work, I would question why you would want to do it. The Quality System is supposed to be reflective of how YOU manage your business.

If the question is about adopting your vendor's procedures for developing software, that should NOT be in your QS since you don't develop software. You are contracting out for that service so your QS would describe how you manage software vendors (as part of purchasing controls, for example).

If you're wanting to adopt more generic procedures (e.g., CAPA) then even if it works for you, you still need to perform it internally so make it yours. If there was an error in their system then you would be adopting a system with an error! If they correct the error, how would you know to update? If they call out specific roles that you don't have, will you create roles just to adapt to the QS? If their QS assumes some skills for some roles, will you have those skills? Will you even know what the skills are?

I would not recommend adopting at all. I think it's just too big a risk. Use the good ideas but make them fit your company.
 

sagai

Quite Involved in Discussions
#5
Re: Using a vendor's quality system...

I am 100% with the principles pointed by Yodon.
I am just looking out of my head and I do not understand how the supplier qms could be an option for a manufacturer. Doing the job you have described can be as complicated as a surgery operation in this way and at the end likely you will spend more than you would have done alone.
Regards, Szabolcs
 
N

Noblelobo

#6
Our problem is that we are creating a system that uses already FDA approved devices, minus the software that links them. This software is being developed by a software consulting firm. We have no experience with software and do not plan on making our software anytime soon. We do not really manufacture anything. We will be contracting everything out. The devices that are already approved will shipped to our facility, we will hook them up to a mobile phone via blutooth, and the software installed in the phone and our servers link up everything.
 

somashekar

Staff member
Super Moderator
#7
Our problem is that we are creating a system that uses already FDA approved devices, minus the software that links them. This software is being developed by a software consulting firm. We have no experience with software and do not plan on making our software anytime soon. We do not really manufacture anything. We will be contracting everything out. The devices that are already approved will shipped to our facility, we will hook them up to a mobile phone via blutooth, and the software installed in the phone and our servers link up everything.
They said it was ok as long is it was part of our quality system and procedures.
As the s/w is a major component and is outsourced, a good quality agreement that is established independent of other prevailing agreements between you and the outsourced s/w consulting firm, in itself can be said as being part of your quality system and procedures.
 

sagai

Quite Involved in Discussions
#8
Hi,
I would raise some considerations.
1.,
Regardless you are "hook them up to a mobile phone via blutooth" I think the "system" is subject to market clearance, due to obvious reason, it has it is own intended use.
So I think you will be the manufacturer with all the consequences and it is not limited to ISO13845 only.
2.,
I would spend an investigation on whether or not the SW component manufacturer subject to establishment registration.
3.,
the totally outsourced SW development
Well, if you can not claim control on the r&d QMS, I think you should validate all released sw version prior building into your system (possible you do not want to do that).
I think, the only way not to take that lane, if you can ensure the conformance of your SW vendor QMS to cGMP and to ISO13485. To do so, you should ensure that in the quality agreement, you should state that, and you should check them in the course of customer audit and follow up and control the whole process.
If you do not have such knowledge, involvement of third party expertise could help, well, lot of option could be, it depends on your intent.

Regards
Szabolcs
 
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