Is a subcontractor required to be ISO 13485 certified?

C

Crimson

#11
ISO 9001 has no requirement for software validation or risk management - therefore may be inadequate for medical device (or other health & human safety) applications.
 
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O

oskameyer

#12
To take this discussion one step further, if the sub-contractor for a finished device is ISO 13485 registered, what products must they list in the Scope of the certificate?

My company outsources the manufacturing and packaging of our finished devices to an IS0 13485 company overseas. Their current ISO 13485 certificate does not mention our products. My company's ISO 13485 certificate includes "Manufacture" of our products in its Scope, and we have full access to the sub-contractor's procedures and records pertaining to our products. We audit them every year and conduct weekly meetings with them as part of our supplier control system. But our NB auditor now tells us that our sub-contractor's certificate must be updated as it does not show they are authorized to manufacture our products. Is this accurate?
 

somashekar

Staff member
Super Moderator
#13
To take this discussion one step further, if the sub-contractor for a finished device is ISO 13485 registered, what products must they list in the Scope of the certificate?

My company outsources the manufacturing and packaging of our finished devices to an IS0 13485 company overseas. Their current ISO 13485 certificate does not mention our products. My company's ISO 13485 certificate includes "Manufacture" of our products in its Scope, and we have full access to the sub-contractor's procedures and records pertaining to our products. We audit them every year and conduct weekly meetings with them as part of our supplier control system. But our NB auditor now tells us that our sub-contractor's certificate must be updated as it does not show they are authorized to manufacture our products. Is this accurate?
While you are the manufacturer and legal manufacturer, if you subcontract the entire manufacturing and packaging as you describe to an ISO 13485 certified manufacturer, then his scope must have been "Contract Manufacturing of xyz medical devices"
If his scope does not say this, it goes to show that his QMS is not geared up to handle your complete manufacturing including packaging.
Think about it .... Would you feel comfortable if his QMS scope is anything less that what he is doing for you ... ?
 
Last edited:
M

MIREGMGR

#14
To take this discussion one step further, if the sub-contractor for a finished device is ISO 13485 registered, what products must they list in the Scope of the certificate?

My company outsources the manufacturing and packaging of our finished devices to an IS0 13485 company overseas. Their current ISO 13485 certificate does not mention our products. My company's ISO 13485 certificate includes "Manufacture" of our products in its Scope, and we have full access to the sub-contractor's procedures and records pertaining to our products. We audit them every year and conduct weekly meetings with them as part of our supplier control system. But our NB auditor now tells us that our sub-contractor's certificate must be updated as it does not show they are authorized to manufacture our products. Is this accurate?
My company Manufactures a broad range of products, and also contract manufactures (or "OEM Manufactures") a further broad range of products. Our ISO 13485 certificate is for the "design, manufacture, distribution and contract manufacture of ...". Perhaps such "contract manufacturing" language is what your NB would like to see in your supplier's certificate.
 
J

jscholen

#15
I would tend to agree with MIREGMGR on wording.

On a similar note, I have noticed a shift in some of our contract manufactures NOT to register with FDA as a manufacturer of finished devices. They have some pretty heavy hitters in Washington DC backing up their arguement.

The true manufacturer is the Spec Developer.

Anyone else having a similar experience?
 
X

XIO549

#16
Hi Guys,

Tell me if there is another place for this query (new here and dont want to be seen as hijacking your thread, albeit old).

However it is related.

I work for a company who do not actually make medical devices, but supply tools and molds into medical device manufacturing companies.

We are getting ready for ISO9001:2008 registration and have been discussing getting 13485 approved also for the reason of demonstrating (a) we are familiar with clients needs and (b) so that we can get more work in this field.

However, does this mean that although we would not manufacture medical devices, that we would have to comply with regulations that need not actually apply - ie: are we bringing unnecessary cost on ourselves just to demonstrate that we can perform in this industry?

Would be great to hear your comments on same.

Thanks
Xio:)
 
M

MIREGMGR

#17
I don't think 13485 includes any aspects that a critical supplier to a medical device maker shouldn't care about.

If your products were commodities, it would be more than you'd need. If however your products significantly affect the quality and performance of your customer's products, and if you want your customer to see you as helping them control their product risks, then 13485 makes sense.
 
X

XIO549

#18
Our clients, being medical device manufacturers use our products as their tools.
So for example the plastic that they make is from the mould that we give them, so ya, our product directly affects their product.

My point would be that having ISO would be a business asset and certainly ad value and increase quality of product for us, but if we were to implement such a stringent QMS as 13485 in a toolmaking company, would this tie us down to more stringent regulations that we need not be tied into?
EG: Software supplier issues in 13485 that are not in 9001:2008

Thanks MIREGMGR

Xio
 
J

jscholen

#19
Xio,

Unless you are making finished devices, you don't need to pursue any medical device standard(ISO 13485). I would encourage you to improve your response to customer needs by providing specific services to companies who make medical devices and be knowledgeable about them before they ask...understand:
What it means to qualify a mold for medical devices
What it means to do Installation Qualification, Operational Qualification and Performance Qualification.

If the customer is within FDA regulatory requirements, then they are suppose to have quality requirements for you that are spelled out in a supplier agreement and somehow managed to assure that the requirements are being met.

You are creating more work for your company if you intend to move to 13485 as that will create more burden on your processes that may not affect medical device companies. You could attempt to have both certifications(9001 and 13485) and have a hybrid approach to taking care of customers, but I think this is more work than is worth it.

I don't see having ISO 13485 as an asset. Knowledge about your customers needs is an asset. Spend the money to send some people to medical device seminar on process qualification or similar topics.

Is having 13485 create additional regulatory burden? NO. Unless you are making finished devices, there is no regulatory requirement for you. Only your customer has that burden, but they may pass on some of their requirements to you, ie, agreed to within the supplier agreement.
 
M

MIREGMGR

#20
My company expects certain critical suppliers to be certified to ISO 13485 rather than ISO 900X, even though they don't make finished devices, because it indicates a seriousness about being a supplier to medical device makers. If a supplier wants to sell us certain products/services they have to be on board with our regulatory commitment, not just our quality stance. When we talk to them about the risks to our end users if a component or service they've provided was ineffective in some specific way, we want them to know exactly what we're doing, and what data they can provide to best fit our need.

We also consider who issued the supplier's certificate.
 
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