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ISO 13485 plus ISO 9001:2015 will now attract a minimum 2 day upgrade audit

somashekar

Staff member
Super Moderator
#1
We just got a message from our ISO 13485 CB, that the upgrade to ISO 9001:2015 along with the renewal of the ISO13485 will now attract a minimum 2 day upgrade audit. The two days is contingent on conducting the audit concurrently with a regularly scheduled ISO13495/9001 audit. The cycle will continue forward perhaps with an additional 1.0 to 1.5 days surveillance audit and 2.0 additional days in triennial recertification audit. These additional days will be in addition to the normally scheduled days to perform the ISO 13485 audits.
We need to give our agreement within a months time failing which it means that we are no longer interested in keeping certification to ISO9001.
 
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Stijloor

Staff member
Super Moderator
#2
Re: ISO 13485 + ISO 9001:2015 will now attract a minimum 2 day upgrade audit

A Quick Bump!

I case you missed this post.
 
#3
Re: ISO 13485 + ISO 9001:2015 will now attract a minimum 2 day upgrade audit

Hello to all the members of the cove!
Thank you very much for all the contributions at this fantastic web-site.
I'd like to add that our NB (TUV) even advised us to cancel the re-certification of ISO 9001:2015 as ISO 13485 is no longer "ISO 9001 plus some extras", but they move on two different paths (since the last revisions).
 

Ajit Basrur

Staff member
Admin
#4
Re: ISO 13485 + ISO 9001:2015 will now attract a minimum 2 day upgrade audit

Yeah, even I have heard of some contract manufacturing organizations who used to hold both ISO 9001 and ISO 13485 are giving up their ISO 9001 due to divergent pathways.
 

jradford

Involved In Discussions
#5
Re: ISO 13485 + ISO 9001:2015 will now attract a minimum 2 day upgrade audit

I would like to keep this thread going. We are a medical device manufacturer in the US. We have held both certification because of them being so similar in the past. The reason we held both is because we ship to many additional counties other than the US and Europe. Some of those countries required 9001 as proof of a quality system. Is 13485 now accepted worldwide? The last couple countries I registered into accepted 13485. Does anyone know a country which still requires 9001 and who will not accept 13485? This would be the only reason I would try to hold both certifications.

Thanks for your input. :bigwave:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
Re: ISO 13485 + ISO 9001:2015 will now attract a minimum 2 day upgrade audit

Does anyone know a country which still requires 9001 and who will not accept 13485?
Representatives from a country which would require ISO 9001 certification in lieu of ISO 13485, a medical-device specific QMS standard, would have to be profoundly uneducated, uninformed or simply dumb.
 

Ajit Basrur

Staff member
Admin
#7
Re: ISO 13485 + ISO 9001:2015 will now attract a minimum 2 day upgrade audit

I would like to keep this thread going. We are a medical device manufacturer in the US. We have held both certification because of them being so similar in the past. The reason we held both is because we ship to many additional counties other than the US and Europe. Some of those countries required 9001 as proof of a quality system. Is 13485 now accepted worldwide? The last couple countries I registered into accepted 13485. Does anyone know a country which still requires 9001 and who will not accept 13485? This would be the only reason I would try to hold both certifications.

Thanks for your input. :bigwave:
Could you please tell us which countries required ISO 9001 as a proof of quality system for medical devices ?
 

jradford

Involved In Discussions
#8
Re: ISO 13485 + ISO 9001:2015 will now attract a minimum 2 day upgrade audit

In reality I think this goes back to the early days of 13495. It was new, so not all countries were recognizing it yet. They were still following 9001 as the standard.

I just took a look at my spreadsheet of countries we are registered in and what they required. They all required some combination of CE/CFG/13485. So I think I am fine suggesting to management that we drop 9001 when our 3 year cycle comes around again in 2018.

Unless there is some reason to keep both certifications which I am missing.
 

shimonv

Trusted Information Resource
#10
I was involved in many submissions in LATAM and Asian countries and never was asked for ISO 9001 certificate.
I see no sense in keeping ISO 9001 for a medical device manufacturer.
 
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