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Who has had to move from ISO 9001:2015 to ISO 13485 and what were the challenges?

ISO_Man

Involved In Discussions
#1
Apparently there are some possible changes on the horizon which would make hand-held medical devices class 2 instead of class 3 which would allow FDA audits of suppliers for the parts. So if I have to move my company from ISO-9001:2015 compliance to ISO-13485 compliance what are the major challenges and can anyone suggest some good documentation on the topic so I don't have to buy the ISO-13485 standard yet?
 
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yodon

Staff member
Super Moderator
#2
Not sure how accurate your information is. First, FDA doesn't recognize 13485 (yet). Second, I don't see how downgrading a device to a lower class would prompt for FDA inspections ("audits") of a supplier. Third, "hand-held" devices can be in any class - depends on a number of factors but mostly risk.

All that aside, if you're not the legal manufacturer, the leap from 9001 to 13845 won't be that big. Much of the device-specific things will likely be not applicable to you. You also don't have all that "context of the organization" stuff from 9001.

Irrespective of the argument about the necessity to switch, you might want to consider holding both 9001 and 13485. It's a little more work and a little longer audit time but it might give you a competitive advantage.
 
#3
This is something that is probably in our future as well. What would you define as the "legal manufacturer"? The manufacturer that delivers the final end component?
 

Mikilk

Involved In Discussions
#5
I would not say it is that easy and not sure if it can be considered "moving" or "Upgrade" as ISO 9001:2015 version is different than the concept of ISO 13485:2016 version. ISO 9001:2015 changes to a new structure different from ISO 13485: 2016.
ISO 13485 is not formally accepted by the FDA but the FDA's QSR is more close to ISO 13485.
I assume comparison matrixes can be found on the web, same as to abstracts / plain text of ISO 13485, but I disagree with my friends here that say it is easy to implement. It is a significant change and held different approach
as the responsible entity of medical device - you much meet all FDA requirements and if the GMP is part of it (not exempt), you should implement it in full without any further delays, and by doing that it will be worth to implement the ISO 13485 standard.
 

yodon

Staff member
Super Moderator
#6
...as the responsible entity of medical device...
Maybe I was mistaken but I understood the OP to indicate they were a supplier, not the legal manufacturer. In this case, much of the uniqueness in 13485 is reduced.

I think going from 13485 to 9001 would be a bigger leap for a company than going from 9001 to 13485 for just the reason you mentioned (different structure).
 

ISO_Man

Involved In Discussions
#7
Not sure how accurate your information is. First, FDA doesn't recognize 13485 (yet). Second, I don't see how downgrading a device to a lower class would prompt for FDA inspections ("audits") of a supplier. Third, "hand-held" devices can be in any class - depends on a number of factors but mostly risk.

All that aside, if you're not the legal manufacturer, the leap from 9001 to 13845 won't be that big. Much of the device-specific things will likely be not applicable to you. You also don't have all that "context of the organization" stuff from 9001.

Irrespective of the argument about the necessity to switch, you might want to consider holding both 9001 and 13485. It's a little more work and a little longer audit time but it might give you a competitive advantage.
Maybe I got the numbers reversed but it's the re-classification of medical devices that makes me consider the 13485 since the FDA can just close the doors on me as a supplier for parts that go into medical devices if they find a major non-conformance during an audit.
 

Al Rosen

Staff member
Super Moderator
#8
Maybe I got the numbers reversed but it's the re-classification of medical devices that makes me consider the 13485 since the FDA can just close the doors on me as a supplier for parts that go into medical devices if they find a major non-conformance during an audit.
If your concern is FDA compliance look at CFR - Code of Federal Regulations Title 21 to see how it might affect you. You can integrate it into your current system without the additional costs associated with ISO 13485 registration.
 
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