Our company just got registered to ISO 13485 - and many thanks go to the helpful people who gave advice on this forum!

We will soon be manufacturing a class II device for sale in Canada and the US. We wish to outsource much of the manufacturing to a contractor who has a 9001:2000 registration. Ideally, this includes having them buy raw materials, make parts, do final inspection, and ship part of a device directly to the customer. I understand that we are required to demonstrate control of their processes.

There are quite a few quality related and legal stipulations that need to be clear between our two parties. I want to get the ball rolling with these guys quickly. I'm worried that if I try to write such an agreement from scratch, I'll end up having to pay a lawyer $122342239852520 and frightening the contractor by imposing unnecessary requirements. I imagine that this type of relationship and this type of agreement must be fairly common.

My question is: Does anyone know where can I find more guidance - or a template - on the type of agreement that typically exists between two such parties?

Thank you!

Our company just got registered to ISO 13485 - and many thanks go to the helpful people who gave advice on this forum!

We will soon be manufacturing a class II device for sale in Canada and the US. We wish to outsource much of the manufacturing to a contractor who has a 9001:2000 registration. Ideally, this includes having them buy raw materials, make parts, do final inspection, and ship part of a device directly to the customer. I understand that we are required to demonstrate control of their processes.

There are quite a few quality related and legal stipulations that need to be clear between our two parties. I want to get the ball rolling with these guys quickly. I'm worried that if I try to write such an agreement from scratch, I'll end up having to pay a lawyer $122342239852520 and frightening the contractor by imposing unnecessary requirements. I imagine that this type of relationship and this type of agreement must be fairly common.

My question is: Does anyone know where can I find more guidance - or a template - on the type of agreement that typically exists between two such parties?

Thank you!Sounds like something large, like an MRI or patient handling system.;)

There are quite a few quality related and legal stipulations that need to be clear between our two parties. I want to get the ball rolling with these guys quickly. I'm worried that if I try to write such an agreement from scratch, I'll end up having to pay a lawyer $122342239852520 and frightening the contractor by imposing unnecessary requirements. I imagine that this type of relationship and this type of agreement must be fairly common.


You need a lawyer. I don't mean to be rude, but what makes you think that you're qualified to draft important contracts, especially if you come to the Cove looking for guidance? Don't get me wrong, we welcome your questions and participation, but I can just about guarantee you that if you don't involve a qualified business attorney, someday you'll wish you had.

Thanks for the replies.

I understand I need a lawyer, and I fully intend to consult one before anyone signs anything. But a lawyer won't know anything about quality system requirements.

I guess to focus my question a bit - I'm interested in the quality system requirements I place on my subcontractor. I'm looking for guidance on what are the most important or most often overlooked aspects of such an agreement.

I'm simply saying I don't want to totally re-invent the concept of "virtual manufacturing" from scratch for no reason, when this must be a common activity.

Naturally, every situation is different, and I will need to keep that in mind and not simply apply a generic template to a unique situation.

Thanks for the replies.

I understand I need a lawyer, and I fully intend to consult one before anyone signs anything. But a lawyer won't know anything about quality system requirements.

I guess to focus my question a bit - I'm interested in the quality system requirements I place on my subcontractor. I'm looking for guidance on what are the most important or most often overlooked aspects of such an agreement.

I'm simply saying I don't want to totally re-invent the concept of "virtual manufacturing" from scratch for no reason, when this must be a common activity.

Naturally, every situation is different, and I will need to keep that in mind and not simply apply a generic template to a unique situation.Two things come to mind immediately:

You need to be notified of any change that might affect the finished device. Look at 21cfr820.50(c) (FDA)
You will need to verify the purchased product in some way. See 21cfr820.80(b)

Another issue you are facing is that the CMDCAS auditor can require that they audit your supplier if it is not registered to ISO 13485 by a CMDCAS Registrar. You can find information on this in the guidance document, GD210/RevDR - ISO 13485 and ISO 13488 quality system audits performed by CMDCAS recognized Registrars. It's attached in post #3 (http://elsmar.com/Forums/showpost.php?p=61381&postcount=3) of the thread, CMDCAS vs. ISO13485 - Additional requirements to normal ISO 13485 for CMDCAS audits? (http://elsmar.com/Forums/showthread.php?t=7145)

Great stuff. I'm glad to get the replies. I was hoping to avoid having a registraar audit the subcontractor, of course. Our lead auditor said that the trend was less and less to audit subcontractors, wherever it is avoidable.

I imagine our organization will be carrying out audits of our subcontractors as a means of ensuring that are requirements are being met (e.g. all verification testing and purchasing controls are conducted properly). But I'm not sure if that is customary or how often it is necessary.