Auditors Auditing Against ISO 9001:2015 Draft

[rob73]

We were lucky our NB/CB auditor had'nt even seen a copy of it!
Rob

 

[TPMB4]

Stupid question from a novice, what is the value that is added by auditing against a draft standard that has not been issued and might never be issued as the current draft? I don't get it.

Also, I understand with each ISO 9001 version you get a transition period equal to one certificate cycle (3 years). I could be wrong but that happened with 2000 and 2008 versions I think so why would it not with 2015 (or whenever it finally gets issued)? If it does allow for this transition period then surely there is no point or value to be added by auditing against the draft version? As I said, I just don't get it.

 

[TPMB4]

+1 on the comments about contract and both sides agreeing to the audit method/standard used. They are providing a service to your company which is the customer and there will be a contract relating to this. Any deviation from the contract without agreement is against commercial law I think. If your bosses agreed to the deviation then you have to live with it for similar reasons, namely it is part of the contract both sides signed up to. More fool them if that happened but it is you who has to live with working to the current standard and to a draft standard too.

BTW how much different in real terms is the 2015 draft?? Would you say it is mostly equivalent to the current or has there been a game changer here?

 

[rob73]

Tpmb4
For us its a major change, we have both 9001 and 13485, the new standard diverges from 13485 in a couple of major ways. When I showed a copy of the draft to our CB/NB auditor his initial opinion was that the two standards could not work side by side.
I would be certainly interested in the opinion of other in our position (i.e 9001 and 13485 certs)
Rob

 

[Colin]

Here is a rough analysis of the changes being proposed.

 

[TPMB4]

Thanks Colin, a really helpful document. Some interesting changes I think.

 

[Helmut Jilling]

Tpmb4
For us its a major change, we have both 9001 and 13485, the new standard diverges from 13485 in a couple of major ways. When I showed a copy of the draft to our CB/NB auditor his initial opinion was that the two standards could not work side by side.
I would be certainly interested in the opinion of other in our position (i.e 9001 and 13485 certs)
Rob

That's silly...13485 is based on ISO 9001....it is highly unlikely that they will not harmonize 13485 to it when the changes become finalized. Traditionally, the addon standards come out a year later. Also, in most cases, the updates don't contradict previous requirements. So, they will likely supplement current requirements in 13485. That sounds like foolish talk coming from an auditor, unless he read the draft and made his conclusion based on specific passages.

 

[Helmut Jilling]

Hello,

I have noticed that some auditors are already auditing against the committee draft of the ISO 9001:2015. Most of them classify the findings as observations.

In my opinion it's not right. The document is barely in its initial draft and findings like that may confuse people. What if some of those requirements don't make it to the final draft?

I don't know if you're seeing the same practice.

Auditing to the 2015 draft is not appropriate it is only a discussion draft and has not been authorized for certification. The language is not even final or voted on yet. Perhaps an interesting comment now and then, but I would NEVER write something like that in a report...An ANAB witness auditor would definitely take issue with that, as should the audit review panel at the CB.

 

[Sidney Vianna]

That's silly...13485 is based on ISO 9001....it is highly unlikely that they will not harmonize 13485 to it when the changes become finalized. Traditionally, the addon standards come out a year later.

Apparently you have not been following the News on the ISO 13485 revision - 2011 - 2012 (now 2014?) thread. One of our ISO 13485 resident experts in The Cove, and member of the ISO TC 210, has already mentioned that the upcoming version of the ISO 13485 standard will NOT follow the High Level Structure, thus, by definition, will not be aligned with ISO 9001:2015. How compatible will ISO 13485:2014 and ISO 9001:2015 be? Impossible to answer at this time, but it seems that they will significantly diverge from the current "alignment".

Similarly, a couple of people have already mentioned in this Forum that the ISO/TS 16949 standard is NOT going to remain aligned with ISO 9001. While that is unsubstantiated, at this time, there is a chance that several standards, currently using ISO 9001 as the baseline, stop doing so.

 

[Helmut Jilling]

Apparently you have not been following the News on the ISO 13485 revision - 2011 - 2012 (now 2014?) thread. One of the ISO 13495 resident experts and member of the ISO TC 210 has already mentioned that the upcoming version of the ISO 13485 standard will NOT follow the High Level Structure, thus, by definition, will not be aligned with ISO 9001:2015. How compatible will ISO 13485:2014 and ISO 9001:2015 be? Impossible to answer at this time, but it seems that they will significantly diverge from the current "alignment".

Similarly, a couple of people have already mentioned in this Forum that the ISO/TS 16949 standard is NOT going to remain aligned with ISO 9001. While that is unsubstantiated, at this time, there is a chance that several standards, currently using ISO 9001 as the baseline, stop doing so.

You are correct, I don't follow 13485....it would be very surprising if they do not align... there is no logic to be a "standard," then unstandardize the standard. I suspect that will resolve itself over time, or they will decouple from ISO 9001 altogether.

On TS-16949, recently in July 2013 I was in a meeting with Dale Hammer, IAOB President, and he commented that he expects that TS will adopt the ISO 9001 changes, and do a release perhaps in 2016. That would be consistent with the pattern that ISO standards have followed.