Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We implemented ISO14971:2019 into our QMS as the state or art. During the NB audit (IVDR QMS) our auditor told us that we need to keep the previous version of ISO14971 too, because it is harmonised to EU IVDD, and we still have IVDD certified devices. We were told that otherwise we would be given a Major finding in our next NB audit (when we renew our IVDD certificates). 
We think the auditor is wrong, and there can be only one SOTA in terms of ISO standards. 
Can I have the views from the experts, please?

I and others in the Forum have previously narrated about the intended voluntary nature of harmonized standards.  As a general rule, no NB should ever mandate conformity with a harmonized standard.  Here's a prior Forum discussion for detailed basis about that: https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=1b365fc8-cd3c-443a-9d5c-0962a690ef1b&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bm1b365fc8-cd3c-443a-9d5c-0962a690ef1b.

A possible wrinkle in the above general rule is if the harmonized standard is generally acknowledged to be state of the art.  Yet even "state of the art" is open for interpretation and negotiation (see MDCG 2021-5 and my posted linked above).

If an NB threatened a major nonconformity for not complying with a harmonized standard, then I would most certainly and politely remind the NB of the longstanding precedent regarding the voluntary nature of harmonized standards.  Remember that such a push-back needs to also demonstrate that the manufacturer has given due account of the state of the art.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 13-Jun-2021 03:16
From: Anonymous Member
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

This message was posted by a user wishing to remain anonymous

We implemented ISO14971:2019 into our QMS as the state or art. During the NB audit (IVDR QMS) our auditor told us that we need to keep the previous version of ISO14971 too, because it is harmonised to EU IVDD, and we still have IVDD certified devices. We were told that otherwise we would be given a Major finding in our next NB audit (when we renew our IVDD certificates).
We think the auditor is wrong, and there can be only one SOTA in terms of ISO standards.
Can I have the views from the experts, please?

Kevin is more polite than me.

I would file a formal complaint against the auditor with your Notified Body and if they do not correct the concern, file a complaint with their Designating Authority.  Really this has to stop.  This definitely would not constitute a Major finding, the auditor is stepping way over their remit and needs to be re-trained on auditing principles and practices in particular scope and audit criteria.  A Major finding even by most Notified Body definitions is the lack of a process (no procedure), compromising safety or performance of device, or systemic issues, not following a previous standard.  More importantly these auditors need to use the grey matter sitting between their ears with a dose of common sense.

You are right Anon, you would only follow one version of a standard which should be the most current.  This has been stated multiple times in forums posts, stated by Competent Authorities who recognise the harmonised standard system is broken, and even other Notified Bodies.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 14-Jun-2021 13:19
From: Kevin Randall
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

I and others in the Forum have previously narrated about the intended voluntary nature of harmonized standards.  As a general rule, no NB should ever mandate conformity with a harmonized standard.  Here's a prior Forum discussion for detailed basis about that: https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=1b365fc8-cd3c-443a-9d5c-0962a690ef1b&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bm1b365fc8-cd3c-443a-9d5c-0962a690ef1b.

A possible wrinkle in the above general rule is if the harmonized standard is generally acknowledged to be state of the art.  Yet even "state of the art" is open for interpretation and negotiation (see MDCG 2021-5 and my posted linked above).

If an NB threatened a major nonconformity for not complying with a harmonized standard, then I would most certainly and politely remind the NB of the longstanding precedent regarding the voluntary nature of harmonized standards.  Remember that such a push-back needs to also demonstrate that the manufacturer has given due account of the state of the art.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 13-Jun-2021 03:16
From: Anonymous Member
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

This message was posted by a user wishing to remain anonymous

We implemented ISO14971:2019 into our QMS as the state or art. During the NB audit (IVDR QMS) our auditor told us that we need to keep the previous version of ISO14971 too, because it is harmonised to EU IVDD, and we still have IVDD certified devices. We were told that otherwise we would be given a Major finding in our next NB audit (when we renew our IVDD certificates).
We think the auditor is wrong, and there can be only one SOTA in terms of ISO standards.
Can I have the views from the experts, please?

This message was posted by a user wishing to remain anonymous

Thank you Richard!
Your response gives us confidence that our understanding is right!
I suspect it is the view of that particular auditor, and I hope that if the  auditor gives us that major NC at the IVDD re-certification audit - our appeal will work!
Thank you!
Original Message:
Sent: 15-Jun-2021 03:55
From: Richard Vincins
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

Kevin is more polite than me.

I would file a formal complaint against the auditor with your Notified Body and if they do not correct the concern, file a complaint with their Designating Authority.  Really this has to stop.  This definitely would not constitute a Major finding, the auditor is stepping way over their remit and needs to be re-trained on auditing principles and practices in particular scope and audit criteria.  A Major finding even by most Notified Body definitions is the lack of a process (no procedure), compromising safety or performance of device, or systemic issues, not following a previous standard.  More importantly these auditors need to use the grey matter sitting between their ears with a dose of common sense.

You are right Anon, you would only follow one version of a standard which should be the most current.  This has been stated multiple times in forums posts, stated by Competent Authorities who recognise the harmonised standard system is broken, and even other Notified Bodies.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Jun-2021 13:19
From: Kevin Randall
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

I and others in the Forum have previously narrated about the intended voluntary nature of harmonized standards.  As a general rule, no NB should ever mandate conformity with a harmonized standard.  Here's a prior Forum discussion for detailed basis about that: https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=1b365fc8-cd3c-443a-9d5c-0962a690ef1b&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bm1b365fc8-cd3c-443a-9d5c-0962a690ef1b.

A possible wrinkle in the above general rule is if the harmonized standard is generally acknowledged to be state of the art.  Yet even "state of the art" is open for interpretation and negotiation (see MDCG 2021-5 and my posted linked above).

If an NB threatened a major nonconformity for not complying with a harmonized standard, then I would most certainly and politely remind the NB of the longstanding precedent regarding the voluntary nature of harmonized standards.  Remember that such a push-back needs to also demonstrate that the manufacturer has given due account of the state of the art.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 13-Jun-2021 03:16
From: Anonymous Member
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

This message was posted by a user wishing to remain anonymous

We implemented ISO14971:2019 into our QMS as the state or art. During the NB audit (IVDR QMS) our auditor told us that we need to keep the previous version of ISO14971 too, because it is harmonised to EU IVDD, and we still have IVDD certified devices. We were told that otherwise we would be given a Major finding in our next NB audit (when we renew our IVDD certificates).
We think the auditor is wrong, and there can be only one SOTA in terms of ISO standards.
Can I have the views from the experts, please?

This message was posted by a user wishing to remain anonymous

Thank you Kevin,

What worries us is a "double standard" approach requested by the NB auditor, we think only ONE standard can be applied and it must be the state of art.
My question was not about application of standards in general, but about that double standard approach.
According to Article 10 of IVDR - application of harmonised standards appears as a must, but refers to standards harmonised under IVDR.
Our interpretation - there are no standards harmonised under IVDR, hence we use the state of art standard for both - IVDR and IVDD certified devices.
we cannot see why we have to keep the old standard live along with the state of art.




Original Message:
Sent: 14-Jun-2021 13:19
From: Kevin Randall
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

I and others in the Forum have previously narrated about the intended voluntary nature of harmonized standards.  As a general rule, no NB should ever mandate conformity with a harmonized standard.  Here's a prior Forum discussion for detailed basis about that: https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=1b365fc8-cd3c-443a-9d5c-0962a690ef1b&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bm1b365fc8-cd3c-443a-9d5c-0962a690ef1b.

A possible wrinkle in the above general rule is if the harmonized standard is generally acknowledged to be state of the art.  Yet even "state of the art" is open for interpretation and negotiation (see MDCG 2021-5 and my posted linked above).

If an NB threatened a major nonconformity for not complying with a harmonized standard, then I would most certainly and politely remind the NB of the longstanding precedent regarding the voluntary nature of harmonized standards.  Remember that such a push-back needs to also demonstrate that the manufacturer has given due account of the state of the art.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 13-Jun-2021 03:16
From: Anonymous Member
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

This message was posted by a user wishing to remain anonymous

We implemented ISO14971:2019 into our QMS as the state or art. During the NB audit (IVDR QMS) our auditor told us that we need to keep the previous version of ISO14971 too, because it is harmonised to EU IVDD, and we still have IVDD certified devices. We were told that otherwise we would be given a Major finding in our next NB audit (when we renew our IVDD certificates).
We think the auditor is wrong, and there can be only one SOTA in terms of ISO standards.
Can I have the views from the experts, please?

If an NB has demanded that a certain standard is required "because it is harmonised", then it is actually quite necessary to first discuss the role of harmonized standards (see my preceding post in this thread), as such an NB demand is fundamentally flawed and prohibited at the outset.

Regarding a demand for application of multiple versions of the same standard, there is no specific legislative requirement of which I'm aware that requires such duplicity.  Instead, we would generally simply be required to take proper account of the state of the art.

Yet be aware that in a scenario involving devices previously designed, produced, and placed on the market under the MDD requirements rather than the EU MDR requirements, the manufacturer needs to keep available the evidence of conformity (e.g., the evidence of conformity to a possibly outdated standard) on which the corresponding declaration of conformity was based at the time the declaration was made.  I wonder if maybe this is what the NB is trying to say.

If not, and the NB is instead truly trying to demand dual conformity with multiple versions of a standard, then I refer to you Ginger's and Richard's spot-on comments (which I really enjoyed by the way).

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 15-Jun-2021 04:14
From: Anonymous Member
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

This message was posted by a user wishing to remain anonymous

Thank you Kevin,

What worries us is a "double standard" approach requested by the NB auditor, we think only ONE standard can be applied and it must be the state of art.
My question was not about application of standards in general, but about that double standard approach.
According to Article 10 of IVDR - application of harmonised standards appears as a must, but refers to standards harmonised under IVDR.
Our interpretation - there are no standards harmonised under IVDR, hence we use the state of art standard for both - IVDR and IVDD certified devices.
we cannot see why we have to keep the old standard live along with the state of art.




Original Message:
Sent: 14-Jun-2021 13:19
From: Kevin Randall
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

I and others in the Forum have previously narrated about the intended voluntary nature of harmonized standards.  As a general rule, no NB should ever mandate conformity with a harmonized standard.  Here's a prior Forum discussion for detailed basis about that: https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=1b365fc8-cd3c-443a-9d5c-0962a690ef1b&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bm1b365fc8-cd3c-443a-9d5c-0962a690ef1b.

A possible wrinkle in the above general rule is if the harmonized standard is generally acknowledged to be state of the art.  Yet even "state of the art" is open for interpretation and negotiation (see MDCG 2021-5 and my posted linked above).

If an NB threatened a major nonconformity for not complying with a harmonized standard, then I would most certainly and politely remind the NB of the longstanding precedent regarding the voluntary nature of harmonized standards.  Remember that such a push-back needs to also demonstrate that the manufacturer has given due account of the state of the art.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 13-Jun-2021 03:16
From: Anonymous Member
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

This message was posted by a user wishing to remain anonymous

We implemented ISO14971:2019 into our QMS as the state or art. During the NB audit (IVDR QMS) our auditor told us that we need to keep the previous version of ISO14971 too, because it is harmonised to EU IVDD, and we still have IVDD certified devices. We were told that otherwise we would be given a Major finding in our next NB audit (when we renew our IVDD certificates).
We think the auditor is wrong, and there can be only one SOTA in terms of ISO standards.
Can I have the views from the experts, please?

That requirement is so ridiculous.  NB auditor with big britches on.   The old version of the standard (EN ISO 14971:2012) was obsoleted when EN ISO 14971:2019 was published.  Hard to conform to something that does not exist any longer.  Bwa ha ha.  Don't you love politely pushing back on auditors? (Mostly politely).  If they are so not correct for the job, you push back on their management. 


Note that I say this as certified ISO 13485/QSR Lead Auditor.  I can go down the rabbit hole with the best of them, but there is the requirement for fairness, objectivity,  etc.


Good luck.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 13-Jun-2021 03:16
From: Anonymous Member
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

This message was posted by a user wishing to remain anonymous

We implemented ISO14971:2019 into our QMS as the state or art. During the NB audit (IVDR QMS) our auditor told us that we need to keep the previous version of ISO14971 too, because it is harmonised to EU IVDD, and we still have IVDD certified devices. We were told that otherwise we would be given a Major finding in our next NB audit (when we renew our IVDD certificates).
We think the auditor is wrong, and there can be only one SOTA in terms of ISO standards.
Can I have the views from the experts, please?

This message was posted by a user wishing to remain anonymous

Thank you Ginger!
I join Kevin enjoying reading all the responses including yours!
Thank you, experts, for your valuable advice!
Original Message:
Sent: 15-Jun-2021 07:17
From: Ginger Cantor
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

That requirement is so ridiculous.  NB auditor with big britches on.   The old version of the standard (EN ISO 14971:2012) was obsoleted when EN ISO 14971:2019 was published.  Hard to conform to something that does not exist any longer.  Bwa ha ha.  Don't you love politely pushing back on auditors? (Mostly politely).  If they are so not correct for the job, you push back on their management.


Note that I say this as certified ISO 13485/QSR Lead Auditor.  I can go down the rabbit hole with the best of them, but there is the requirement for fairness, objectivity,  etc.


Good luck.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 13-Jun-2021 03:16
From: Anonymous Member
Subject: NB auditor told us both - ISO14971:2019 and previous harmonised to EU directive version should be active in our QMS

This message was posted by a user wishing to remain anonymous

We implemented ISO14971:2019 into our QMS as the state or art. During the NB audit (IVDR QMS) our auditor told us that we need to keep the previous version of ISO14971 too, because it is harmonised to EU IVDD, and we still have IVDD certified devices. We were told that otherwise we would be given a Major finding in our next NB audit (when we renew our IVDD certificates).
We think the auditor is wrong, and there can be only one SOTA in terms of ISO standards.
Can I have the views from the experts, please?