Major nonformance finding was given during a closing meeting of a ISO9001 certification audit

Coury Ferguson

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#51
One record could be the Management Review Sign in log. That would show evidence that the meeting was held, I would guess. As for the ISO9001 Standard, it requires only 3 to be recorded/documented for output.

Just my opinion.
 
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tony s

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#52
So where is the record that you considered it?
If the auditor would like to verify the evidence that inputs, as listed in 9.3.2, were considered, IMHO, a record is not mandatory for the following bases:
  • Clause 9.3.2 does not require to retain documented information as evidence that inputs were covered;
  • If we rule it against 9.3.3, it's subjective. The required record here is "evidence of the results of management reviews". So, it is about the outputs not the inputs. Output is defined as "result of a process" and management review is a process;
  • ISO 9001 Auditing Practices Group Guidance on Evidence Collection has this statement: "Auditors should be aware that objective evidence does not necessarily depend on the existence of documented information, except where specifically mentioned in ISO 9001";
  • Records are not the only form of evidence (as per ISO 19011 definition).
I've noticed that most auditors ask records to demonstrate whether all the 9.3.2 inputs were covered, but do we really need to obtain documented evidences for that. Do we ask record/s that the items listed in 4.3a to 4.3c were considered in determining the scope of the QMS?
 

Big Jim

Super Moderator
#53
If the auditor would like to verify the evidence that inputs, as listed in 9.3.2, were considered, IMHO, a record is not mandatory for the following bases:
  • Clause 9.3.2 does not require to retain documented information as evidence that inputs were covered;
  • If we rule it against 9.3.3, it's subjective. The required record here is "evidence of the results of management reviews". So, it is about the outputs not the inputs. Output is defined as "result of a process" and management review is a process;
  • ISO 9001 Auditing Practices Group Guidance on Evidence Collection has this statement: "Auditors should be aware that objective evidence does not necessarily depend on the existence of documented information, except where specifically mentioned in ISO 9001";
  • Records are not the only form of evidence (as per ISO 19011 definition).
I've noticed that most auditors ask records to demonstrate whether all the 9.3.2 inputs were covered, but do we really need to obtain documented evidences for that. Do we ask record/s that the items listed in 4.3a to 4.3c were considered in determining the scope of the QMS?

Perhaps you need to read the final line in 9.3.3 again. You take a very narrow view that I don't think is justified. It doesn't say retain documented information of management reviews outputs. It says retain documented information as evidence of the results of management reviews. That would be all of management review.
 

tony s

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#54
It says retain documented information as evidence of the results of management reviews. That would be all of management review.
If the interpretation of "results of management review" is "all of management review", then why didn't the standard just say "retain documented information as evidence of management reviews".

Maybe there's a profound reason why ISO 9001:2015 version placed the requirement for retaining records in 9.3.3-Management review outputs instead in 9.3.1-General. A meaningful change from the 2008 version where the statement "Records from management reviews shall be maintained" is located at clause 5.6.1-General. This provided us a better view of the value of conducting and documenting management reviews. This also promotes an "output oriented" way of looking at processes.
 

Jim Wynne

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#55
Maybe there's a profound reason why ISO 9001:2015 version placed the requirement for retaining records in 9.3.3-Management review outputs...
If the reason is "profound" and knowledgeable people are here arguing about it, the problem is with the standard. I think that characterizing a nonconformity as "major" might qualify as profound, but the auditor in this case did an absolutely horsebleep job of describing what he found, what the standard says he should have found, and why the NC is major rather than minor.
 

Sidney Vianna

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#56
People fantasize about the hidden "wisdom" contained in standards. The standard development process is far from perfect and, many times, much more influenced by political issues and posturing than technical soundness.
 

Big Jim

Super Moderator
#57
People fantasize about the hidden "wisdom" contained in standards. The standard development process is far from perfect and, many times, much more influenced by political issues and posturing than technical soundness.
This is certainly true. The result is often there for all to see after it is published.
 

Big Jim

Super Moderator
#58
If the interpretation of "results of management review" is "all of management review", then why didn't the standard just say "retain documented information as evidence of management reviews".

Maybe there's a profound reason why ISO 9001:2015 version placed the requirement for retaining records in 9.3.3-Management review outputs instead in 9.3.1-General. A meaningful change from the 2008 version where the statement "Records from management reviews shall be maintained" is located at clause 5.6.1-General. This provided us a better view of the value of conducting and documenting management reviews. This also promotes an "output oriented" way of looking at processes.
And maybe there isn't. I don't believe there is. Perhaps there is a reason that certification body audit workbooks ask if all of the management review inputs were covered, and perhaps there isn't.
 

Big Jim

Super Moderator
#59
If the interpretation of "results of management review" is "all of management review", then why didn't the standard just say "retain documented information as evidence of management reviews".

Maybe there's a profound reason why ISO 9001:2015 version placed the requirement for retaining records in 9.3.3-Management review outputs instead in 9.3.1-General. A meaningful change from the 2008 version where the statement "Records from management reviews shall be maintained" is located at clause 5.6.1-General. This provided us a better view of the value of conducting and documenting management reviews. This also promotes an "output oriented" way of looking at processes.
How can the outputs be evaluated if not all of the inputs were covered?
 

tony s

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#60
but the auditor in this case did an absolutely horsebleep job of describing what he found, what the standard says he should have found, and why the NC is major rather than minor.
I'm also on the same side of the fence that the finding is not a major NC. I even oppose it and assert that it's not even a nonconformity. Yes, I agree that the auditor has committed a profound lapse in judgment to slap the OP with a major NC.
People fantasize about the hidden "wisdom" contained in standards.
Maybe in my attempt to highlight the difference/s in the requirement for retaining record on management review between the 2015 and 2008 versions of the standard, I used the word "profound" before mentioning "reason". Anyway, I hope, with the knowledgeable people here at the Cove, that the statement "Records from management reviews shall be maintained" placed at 5.6.1-General of 2008 is not similar with "The organization shall retain documented information as evidence of the results of management reviews" placed at 9.3.3-Management review outputs of the 2015.
Perhaps there is a reason that certification body audit workbooks ask if all of the management review inputs were covered, and perhaps there isn't.
Whatever the reason or lack of it, I believe, most of us here, will not accept the CB workbooks as audit criteria in the context of the OP's predicament.
How can the outputs be evaluated if not all of the inputs were covered?
9.3.2 use the statement "taking into consideration", I believe, there's some flexibility on this. ISO/TS 9002: 2016 has also this statement: "It is not required that all the inputs to management review be addressed at one time, but instead they may be addressed during sequenced management reviews".
 
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