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

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tony s

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Trusted Information Resource
#32
The MR minutes should reference each and every requirement in 9.3 and if a spefic requirement was not applicanle then it should be recorded as such in the minutes.
Can you provide the specific basis for this assertion?
 

John Broomfield

Staff member
Super Moderator
#33
Hi all,

New to the forum.

Looking for people's comments what immediate actions you would perform if a major conformance was given during a closing meeting of a ISO9001 certification audit?

Thanks
Raymond
Do not accept the nonconformity but offer to adjourn the meeting to verify the evidence.
 

Golfman25

Trusted Information Resource
#34
Can you provide the specific basis for this assertion?
While I agree, I guess it begs the question, how do you prove you considered each input? It might be one of those situations that just having a "check box" on the minutes or review form sends the auditor to something more important.
 

Mikey324

Quite Involved in Discussions
#35
It might be one of those situations that just having a "check box" on the minutes or review form sends the auditor to something more important.
That's a pretty simple method. It's what we do. Our MR's are conducted through the year, so it helps me remember to cover everything.
 
Last edited by a moderator:

Randy

Super Moderator
#36
While I agree, I guess it begs the question, how do you prove you considered each input? It might be one of those situations that just having a "check box" on the minutes or review form sends the auditor to something more important.
Just ask and listen to and document the response
 

tony s

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Trusted Information Resource
#37
Just ask and listen to and document the response
I believe this is a sound approach for collecting evidence. Not all evidences are records. Audit evidence is defined by ISO 19011:2018 as "records, statements of fact or other information, which are relevant to the audit criteria and verifiable". Such information can be obtained by "a) interviews, b) observation of processes and activities, c) review of documentation and records" as per 9.4.4 of ISO/IEC 17021-1:2015. Even the 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".

In making the evidence easy for the auditor, another statement from the same APG guidance is very relevant i.e.:
According to the definition, an audit is a “process for obtaining audit evidence and evaluating
it objectively to determine the extent to which the audit criteria are fulfilled”.
That means that the competent auditor will prepare for the audit in order to know what kind
of evidence he or she needs to look for, and will be able to seek out that evidence rather
than requiring the auditee to “serve up the evidence on a plate”.
 
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Randy

Super Moderator
#38
Yep, but very few either read or understand those simple words. Verification can be obtained by asking another person in the process if possible. It isn't rocket science or trying to get the secret Coca Cola recipe.
 

qualprod

Trusted Information Resource
#39
Yep, but very few either read or understand those simple words. Verification can be obtained by asking another person in the process if possible. It isn't rocket science or trying to get the secret Coca Cola recipe.
Hey Randy , But if you get the evidence of someone asking something, why is the evidence of that answer? A recording of the talk?if it were a document ( as record) you write down as an evidence, a document number xxxx, but in the case of a question, what do you register as evidence?
Thanks
 

tony s

Information Seeker
Trusted Information Resource
#40
By using the OP's issue as a case study:
Not all requirements of the ISO 9001:2015 standard were covered as part of the management review in October 2018 (i.e. effectiveness of actions to address risks and opportunities).
Apparently, the specific input which is "the effectiveness of actions taken to address risks and opportunities" was not covered as per the auditor. If the auditee claimed that this particular input was covered but was not recorded in the minutes of the meeting, how can a competent auditor obtain the objective evidence to support the claim of the auditee and demonstrate conformity to 9.3.2?

First, listen to the explanation of the auditee that might go a little something like this:
  • During planning or changes in their QMS processes, the auditee might have some method for determining actions on risks/opportunities. (Is this the evidence? Not yet);
  • Actions that were determined were incorporated into the auditee's processes and/or procedures. (Is this the evidence?. Not yet);
  • The auditee's organization implemented these actions for some time. (Is this the evidence? Not yet);
  • Then came their internal audit and part of the audit objectives, as specified in their audit itinerary/schedule, is to evaluate the effectiveness of the actions taken to address risks/opportunities. (Is this the evidence? Not yet);
  • The audit checklists and reports for each audited process showed that the "actions" were audited and evaluated for effectiveness by the internal auditors. (Is this the evidence? Not yet);
  • The internal audit reports were discussed during their management review. (Is this the evidence? We're almost there);
Now, the auditor can ask: "Can I see the audit reports that were presented and discussed on your management review?"
At this juncture, the auditee can now demonstrate that the "effectiveness of the actions to address risks/opportunities" were covered as part of their management review. (This is where the evidence can be obtained).
 
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