Having got ISO 13485:2016 are you dropping ISO 9001?

Dave-h

Involved In Discussions
#1
All of our products are medical devices and we sell only into the medical world. With the divergence of the two standards we are planning to drop 9001, although there are some customers around the world who do not yet understand 13485 and still ask for 9001.

Does anyone have any experience of dealing with those customers who seem to think that 9001 is the only game in town?

Thanks.
 
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Edward Reesor

Trusted Information Resource
#3
We are medical device manufacturers and sell only to medical device distributors and have always had 13485 only. Mind you we also conform to 14971 and a whole bunch of standards that are directly related to the devices that we manufacture. To my knowledge, we have never had anyone balk at the fact that we are not 9001 certified (especially when shown that they are all voluntary anyway).

I was filling out the (newer) Health Canada MDL amendment form and noticed that it had a declarations where you confirmed a) that you had certain certifications, or b) that your products conformed to some other standard with objective evidence or has been tested for safety and effectiveness. (see page 7, section 15 of the Class II MDL Amendment Application Form).
 

Ajit Basrur

Staff member
Admin
#4
All of our products are medical devices and we sell only into the medical world. With the divergence of the two standards we are planning to drop 9001, although there are some customers around the world who do not yet understand 13485 and still ask for 9001.

Does anyone have any experience of dealing with those customers who seem to think that 9001 is the only game in town?

Thanks.
Yes, I have heard of few organizations that have decided to surrender their ISO 9001 which they had just as an added feather in the ISO 13485 cap !

At one of my clients, there was only one client who wanted the ISO 9001 but we convinced them of our continuation of ISO 13485 cert only and an assurance to comply with their requirements.
 

John Broomfield

Staff member
Super Moderator
#5
All of our products are medical devices and we sell only into the medical world. With the divergence of the two standards we are planning to drop 9001, although there are some customers around the world who do not yet understand 13485 and still ask for 9001.

Does anyone have any experience of dealing with those customers who seem to think that 9001 is the only game in town?

Thanks.
Dave,

Are you including your sales team in this potentially risky decision?

They may say that retaining evidence that your organization’s management system also conforms to ISO 9001 is still a worthwhile investment.

...how much extra does it cost?

Until your customers are up to speed on ISO 13485, this question may end up being a recurring item on the agenda of management reviews.

Best wishes,

John
 

isolytical

Involved In Discussions
#6
The customer voice and the sales/marketing input are good clues as to how to proceed. When this comes up my answer is usually 'customer education', when the details are not known.
To that end, the explanation, since you are a device manufacturer, is that you are required to follow FDA regulations, namely 21CFR820, and others. Since about 2002-2003 the FDA has harmonized the QSR with ISO13485. With the divergence, the regulations 'favor' using ISO13485.
And if selling into the EU, ISO13485 supports those registrations too.
 
#8
We are 100% medical device contract manufacturer and dropped ISO 9001 at our surveillance audit in 2017. No issues from a customer standpoint or notified body perspective. No sense in continuing with ISO 9001 based on our business focus.
 
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