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ISO 14971 applicability in ISO 13485

DarisS

Starting to get Involved
#1
Hello,
I just had a follow up audit of our ISO 13485 certified system and the auditors issued a non conformity because we are not applying correctly the ISO 14971 for medical devices risk assessment.
My argument of not applying the ISO 14971 was that we are not a medical device manufacturing company, we are "only" designing and manufacturing connectors that may then be incorporated into medical devices by our customers. Those connectors are not specificaly developped for medical devices but are "off the shelves" products.
And when I'm reading the intro of ISO 14971 it says " This document was developed specifically for manufacturers of medical devices on the basis of established principles of risk management that have evolved over many years. This document could be used as guidance in developing and maintaining a risk management process for other products that are not necessarily medical devices in some jurisdictions and for suppliers and other parties involved in the medical device life cycle.".
So my interpretation of that statement is that I could use it as a guidance, but I have no obligation of doing so.
But no way, the auditors wants us to apply the ISO 14971 in full.

Other remark, I don't see any clear reference to the ISO 14971 in the ISO 13485. Only a simple note on chapter 7.1 saying that there are additional information on the ISO 14971.

Any experience to share on that topic?
Thanks
Best Regards,
Daris
 
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John C. Abnet

Teacher, sensei, kennari
Staff member
#2
Good day @DarisS ;
ISO 14971 is, as you stated, a guidance standard. It is NOT a management system standard. It is NOT auditable to.

You may need to escalate this within your CB (Certification Body) or beyone.

Hope this helps.
Be well.
 

DarisS

Starting to get Involved
#3
Thanks John,
I'll escalate the topic to the CB management.

PS: Funny to see that you are located in Geneva - Indiana as I'm working close to Geneva in Switzerland. :)
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#4
Geneva - Indiana as I'm working close to Geneva in Switzerland

HA! Yours is a much more beautiful "Geneva" than mine is. Also, just 6 miles away is "Berne". This area was originally settled by Swiss. In my "Berne" there is a replica of the Muensterberger Clock Tower.

If you are willing, please connect with me on LinkedIn ...

https://www.linkedin.com/in/johnabnet-rakumanagementsystems/

or via my website...

Raku Management Systems – Simple and effective management systems

Be well.
 

DarisS

Starting to get Involved
#6
Before doing that, just make sure you're not claiming compliance to 14971 somewhere!
No, I'm not claiming compliance to 14971. That's the reason of my frustration. The auditors are forcing me to comply with that standard but I do not understand why as I can not find anything on the 13485 that calls for it as a mandatory requirement.
 

William55401

Quite Involved in Discussions
#7
Notified Bodies are a fee for service business model.
By potentially expanding QMS scope to include 14971, it generates additional NB man hours. Escalation to the CB is the right move.
 
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