Is a subcontractor required to be ISO 13485 certified?

A

AMSC9856

#1
Our customer is a 13485 certified medical device manfaucturer who does the final assembly in-house. Are we required to be 13485 certified as a sub-assembly (manily PCBAs and cable assemblies) contract manfuacturer?
 
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M

MIREGMGR

#3
Regulatorily, no. You don't make medical devices.

But, you may want to have a quality system...ISO 9001 or ISO 13485...just to make your business run more effectively. And, your customer might decide that if you don't have a quality system, they can't or won't use you as a vendor.
 

DannyK

Trusted Information Resource
#4
There are several PCB assembly companies who have attained certification to ISO 13485 since they want to supply to the medical devices industry.
There is no requirement to be ISO 13485 unless specified by the customer.
Medical device companies have to show control over their subcontractors and having ISO 13485 may help in justifying not having to perform an audit.
 

somashekar

Staff member
Super Moderator
#5
If your customer is certified to ISO 13485 with CMDCAS and is placing products into Canada, then perhaps he will seek to have ISO 13485 certified suppliers who make and supply to him critical components that would have a bearing on his medical device quality, reliability and safety.
 

Al Rosen

Staff member
Super Moderator
#6
There are several PCB assembly companies who have attained certification to ISO 13485 since they want to supply to the medical devices industry.
There is no requirement to be ISO 13485 unless specified by the customer.
Medical device companies have to show control over their subcontractors and having ISO 13485 may help in justifying not having to perform an audit.
ISO9001 should be sufficient for this.
 
A

arios

#7
ISO 13485 is a voluntary standard.

However it would not be voluntary for manufacturers of Finished Devices who sell in certain markets like in Canada. It may also be required to demonstrate an adequate level of control on certain service suppliers like sterilization facilities

You can be ISO 13485 certified if your customer so requires or for other market reasons. In addition attaining ISO 13485 can help you out to comply better with the FDA QSR as they both overlap on several requirements, so you or your client may have a better readiness in case of an FDA inspection.

Bottom line, whether you produce a Finished device or only components for a Finished medical device it is IMHO a good bussiness and compliance strategy to pursue ISO 13485 certification, so go for it :agree1:
 
J

jscholen

#8
I'll confirm what others have said if it is a customer requirement.

I would not agree in pursuing ISO 13485, unless you are pursuing finished device assembly business. ISO 9001 should be sufficient as a component supplier with a supplier agreement in place.

It really helps medical device companies if you speak the language and understand their requirements(which is a ISO 9001 requirement). You will get more business this way.
 

cubix rube

Involved In Discussions
#9
I'm in the same boat. I recently changed employers, and am working with a component supplier who is going after 13485 certification. My background is 95% automotive for the last 20+ years, so everything specific to 13485/medical is a bit new to me. Add to that, that we're not really a medical device manufacturer, and it's been very difficult, yet enlightening, to research the best way to develop my QMS without boxing myself into any ridiculous requirements that would add unnecessary costs to our process, with little or no value added. I'm working on an advisory notice procedure now, and considering that we only manufacture components that are designed by our customers, with materials specified by our customers, and only delivered to our customers for them to assemble into their devices, it seems the advisory notice would never apply, yet the standard requires that I develop a procedure, so here I go. WOOT!!
 
Q

QualitySage

#10
As a medical device manufacturer, certified to ISO 13485, our notified body requires our use of critical subcontractors certified to ISO 13485. The real work was defining subcontractor levels, then classifying all suppliers based on risk (not for example, by commodity). I used the risks identified on hazards analyses and design FMEAs and chose a threshold that made sense for us.

To get back to the original question, my comment here was just to add that your customer (the device manufacturer) may be required by their notified body to use ISO 13485 certified suppliers. If you are not certified and do not intent to pursue certification (maybe actual certification doesn't make business sense), you could ask your customer about the rationale. Perhaps they have rated your product to be higher risk than necessary and you don't really need to be certified, but they just prefer it. Maybe the customer could audit your compliance to ISO 13485 requirements. Our particular notified body auditor informed me that they would need to audit any of our critical suppliers that were not ISO 13485 certified (at our expense).

Hope this is helpful in providing a little more insight to why a subcontractor could be asked for ISO 13485 certification.
 
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