We Design and Develop - All of our Manufacturing is Outsourced - ISO 13485 Question

[amyjpowers]

Hi, quality folks,
I work for a design and development/R&D facility that develops a natural medicinal salve for treatment of wound care. It's considered a class II medical device. We are an organization of less than 15. I came on board 2 months ago and was tasked with setting up a QMS where no formal systems exist.

As we continue to develop our QMS in preparation for ISO 13485 registration in the future I've run into a couple of snags....or maybe I'm over thinking.....like that's NEVER happened!

We design and develop. The output of our design system is manufacturing specifications that will be sent to our (pending) contract manufacturing organization (CMO). We'll have a Feedback System in place and our lab will be involved with testing/approvals before final manufacturing can take place. Since all of our manufacturing is outsourced, and without "shirking" any responsibility, is it necessary for us to maintain systems for:

• Control of Production and Service Provision
• Monitoring and Measuring of Product
• Control of NC Product

It appears to me that the CMO will have it's own requirements regarding these systems. I'm wondering if a "blurb" of some kind in our Quality Manual will satisfy any external parties.

All thoughts are greatly appreciated.

[sagai]

13485 certification alone makes not too much sense, for EU you have to have a CE marking approval (in US the 51ok market clearance) next to it in order to be able to sell your classII device.
Where are you planning to market this device?
Is this device will be marketed under the name of your company?
Regards
Sz.

[DannyK]

Based on your post I am assuming that the product will be labelled with your company name.

If that is the case, you have to indicate in your quality system the way you control the outsourced processes.
Do you perform audits at your CMO?
Does your CMO have ISO 13485 registration?
If there are customer returns, which company will be responsible?

[MIREGMGR]

21 CFR 820 and ISO 13485 have somewhat similar requirements for each of the QS elements you listed. It would be difficult to not have such functionality in your QS and still be able to pass an FDA inspection that reviewed your control of product realization, given that you are the Manufacturer even if you utilize a contract manufacturer to do the actual formulation and packaging.

[somashekar]

In Reply to Parent Post by amyjpowers

Hi, quality folks,
I work for a design and development/R&D facility that develops a natural medicinal salve for treatment of wound care. It's considered a class II medical device. We are an organization of less than 15. I came on board 2 months ago and was tasked with setting up a QMS where no formal systems exist.

As we continue to develop our QMS in preparation for ISO 13485 registration in the future I've run into a couple of snags....or maybe I'm over thinking.....like that's NEVER happened!

We design and develop. The output of our design system is manufacturing specifications that will be sent to our (pending) contract manufacturing organization (CMO). We'll have a Feedback System in place and our lab will be involved with testing/approvals before final manufacturing can take place. Since all of our manufacturing is outsourced, and without "shirking" any responsibility, is it necessary for us to maintain systems for:

• Control of Production and Service Provision
• Monitoring and Measuring of Product
• Control of NC Product

It appears to me that the CMO will have it's own requirements regarding these systems. I'm wondering if a "blurb" of some kind in our Quality Manual will satisfy any external parties.

All thoughts are greatly appreciated.

This is a nice business thinking and a very good one for application of control over outsourced processes. Since the manufacturing and associated activities as you have indicated are all of clause 7 and 8 (minus design and development) it will do good to make a very good quality agreement with your future CMO, where you will list all the details of your controls exercised, your responsibilities and liabilities and the CMO responsibilities and liabilities. You may also consider putting in the quality agreement his acceptance to be audited by you and your CB / NB towards your ISO 13485 or CE requirements. On a broader level you need to carefully draft a quality agreement and discuss the same internally, with your CB/NB and with your future CMO before signoff and implementation.

[amyjpowers]

Sagai,
We are setting up our systems to be compliant with ISO 13485 and the FDA QSR. My focus is the controlled systems. Another co-worker is on board and investigating the CE marking, etc. We are well aware of the FDA 510K market acceptance. It's being built into our Design and Development system. This device will be marketed under the company name and we intend to go world wide (long term).

Danny and Somashekar....GREAT considerations! Thanks! I believe I have my answer!

Gosh....I love the Cove!!

[Roland Cooke]

Per Clause 1.2, you can only deem elements from Clause 7 as non-applicable, so you will definitely need systems for monitoring/measuring and also for control of NCP, even if this is restricted to ensuring those activities are properly established at your subcontractor, and perhaps dealing with returned product (complaint investigation etc).

[MRWardell]

I know this thread is a little old, but seemed a good place to start. We are CM for a small company that developed a Class II device which received 510(K) approval. This company is the manufacturer of record, although I know we have shared responsibility for complying with QSR. My question - does our customer (the developer of the device) require a QMS per 21 CFR 820? Thanks for your thoughts.