ISO 9001 vs. ISO 13485 Registration - Approximately 1/3 of our customers are medical

K

KCQuality

#1
Have a question for those of you here that have a little more experience than I do...

The company that I work for is currently registered to ISO 9001. Approximately a third of our customers are medical, but we don't build anything that is a direct medical device. They end up being components that are used in an all-up product by an OEM (our products are input devices, typically keyboards). We are thinking about becoming certified to ISO 13485. My questions are:

If our customers aren't requiring it is it a good idea? Does anyone out there have customers that require registration to ISO 13485?

We also build a lot of non-medical products and do not want to impose the 13485 requirements in those instances. Is it acceptable to say that the scope of our 13485 QMS is medical customers only?

Thanks!
 
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pkost

Trusted Information Resource
#2
Re: ISO 9001 vs. ISO 13485 registration

If your customers are not requiring it, what is the benefit you are gaining?

You should evaluate how much business you have missed or lost from not having ISO 13485.

In my previous role, working with Class IIb/III implantables, I prefered ISO13485 over 9001 when selecting a supplier. 13485 wasn't required but I would increase surveillance of businesses that didn't hold it.

Limiting the scope of your certification is certainly possible, you should evaluate whether doing so is worth the trouble though
 
#3
Re: ISO 9001 vs. ISO 13485 Registration - Approximately 1/3 of our customers are medi

Have a question for those of you here that have a little more experience than I do...

The company that I work for is currently registered to ISO 9001. Approximately a third of our customers are medical, but we don't build anything that is a direct medical device. They end up being components that are used in an all-up product by an OEM (our products are input devices, typically keyboards). We are thinking about becoming certified to ISO 13485. My questions are:

If our customers aren't requiring it is it a good idea? Does anyone out there have customers that require registration to ISO 13485?

We also build a lot of non-medical products and do not want to impose the 13485 requirements in those instances. Is it acceptable to say that the scope of our 13485 QMS is medical customers only?

Thanks!
You do not build anything that is direct a medical device, and you are right.
Your customer is not asking 13485 and that is very sensible.
You have no case for a 13485.
For what you are manufacturing, when any of your customer asks you to get into 13485, ask them why as you show the ISO13485 abstract which is HERE
 
W

WisdomseekerSC

#4
Re: ISO 9001 vs. ISO 13485 Registration - Approximately 1/3 of our customers are medi

We are also in the same boat :bigwave:...we make tubing (non-sterile) used in many different industries, mostly medical tubing which is incorporated into a medical device by OEM (customers). Component manufacturers currently do not register with FDA, yet OEMs are required to control their suppliers (us) and are looking for compliance to FDA QSR (cGMP for medical devices) or ISO 13485 (for our international customers) we elected to have ISO 13485 certification for one of our seven facilities that specifically makes implantable component materials. This was a business decision (not required by customers) and we have seen benefits from a marketing/sales perspective.

Note: We do claim exclusions to 7.3.6 for Design and Development Validation since the OEM assumes this responsibility. We also claim non-applicability for 7.5.1.2.2 Installation activities; 7.5.1.2.3 Servicing activities; and several others related to Particular requirements related to sterile and active implantable medical devices.
 
C

celeo

#5
Re: ISO 9001 vs. ISO 13485 Registration - Approximately 1/3 of our customers are medi

There is the other side to this 9001 vs 13485 question.
We have Government tenders issued that require ISO 9001 certification for medical device suppliers / manufacturers that have relevant products and could respond to the tender offer.
A company that supplies class III and IIb devices is trying to decide whether to drop the ISO 9001 certification and maintain only ISO 13485, for cost reasons.
Now a particular Government tender office will not accept ISO 13485 only as the potential supplier does not meet tender requirement to have ISO 9001. How can the company convince them ISO 13485 more than covers ISO 9001 (except for the few parts that are not suitable for regulatory purposes), plus many additional beneficial requirements?
 
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