Do we have to find an ISO clause to define a nonconformity?

D

darkafar

#1
ISO19011 defines “audit criteria” as “set of policies, procedures or requirements”, and “audit findings” as “results of the evaluation of the collected audit evidence against audit criteria”.

So I think for an internal audit it is unnecessary to find an ISO clause to define a nonconformity, as long as the procedures, laws, quality policy, or customer requirements are not followed

My friends disagree, so I want to see if someone here shares my view.

Thanks
 
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antoine.dias

Quite Involved in Discussions
#2
From the ISO 9001 requirements ( used as basis for a lot of other standards )
Quote :

8.2.2 Internal audit
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
b) is effectively implemented and maintained.

Unquote

( I did add the underlining )

So, from this requirement it is very well possible that a non conformity can be set against an internal requirement (e.g. in a procedure) without the need to refer to an item in the standard.

Best regards,

Antoine
 
C

chergh - 2008

#3
When raising and reporting NC's in internal audits I never mention a standard clause. I will raise NC's against our internal documents, sales orders, service level agreements etc. but never an ISO standard clause. Most of my internal audit team have never read the ISO 9001 standard that we are certified to. Our system is built to conform to the 9001 standard and by auditing against our processes and procedures we ensure that our QMS conforms "to the requirements of this international standard" 8.2.2.a.

When new processes are being introduced or existing processes modified I will be involved and will ensure that ISO 9001 requirements are met.
 
C

chergh - 2008

#4
In addition to what I just wrote I also believe that raising NC's against an ISO standard, as it is an external document to which our company has had no input to, would also lead to an increase in negative perception about our QMS where as raising NC's against internal documents etc. is less likely to as these are what we as a company have decided to do.
 
C

Craig H.

#5
Why not cite both the internal nonconformance and a reference to the applicable ISO 9001 clause?
 

Antonio Vieira

Involved - Posts
Trusted Information Resource
#6
However we must consider one different kind of internal audit.
Those I’m hired often to do:
- Internal audits made by an external auditor, just before registration audit.
In this kind of internal audit I’m always told by the quality manager of the audited organization that I should perform the audit on the basis of ISO 9001 requirements.

Of course that if we consider the real internal audit we just have to check if internal processes are according to what is supposed to be. But this is only possible assuming that the system is already according to ISO 9001 requirements, otherwise we will have a process audit and not a system audit.
:cool:
 
C

chergh - 2008

#7
Why not cite both the internal nonconformance and a reference to the applicable ISO 9001 clause?
I just don't see any benefit in citing the ISO clause. Myself and my boss may get some benefit by having a look at number of NC's versus the ISO clause but in general the auditor is not going to be capable of assigning an NC to the appropriate clause and I see no benefit at all to the auditee or the process owners.
 
C

Craig H.

#8
I just don't see any benefit in citing the ISO clause. Myself and my boss may get some benefit by having a look at number of NC's versus the ISO clause but in general the auditor is not going to be capable of assigning an NC to the appropriate clause and I see no benefit at all to the auditee or the process owners.
I have certainly been in situations where being able to "show the shall" in the standard has ended "discussions" with groups I have audited.

If you feel comfortable running around uncovered like that, then by all means...
 
C

chergh - 2008

#9
If you feel comfortable running around uncovered like that, then by all means...
Uncovered like what?

I would much rather spend more time convincing the process owner there is a real benefit to the item/activity rather than saying "we have to do it to comply with ISO 9001". Quoting 9001 is more likely to result in reinforcing negatives attitude towards the QMS than anything else.
 
C

Craig H.

#10
Uncovered like what?

I would much rather spend more time convincing the process owner there is a real benefit to the item/activity rather than saying "we have to do it to comply with ISO 9001". Quoting 9001 is more likely to result in reinforcing negatives attitude toward the QMS than anything else.
Believe me, I despise doing anything just "to meet the standard" (see my rants on "Customer Satisfaction" for example). But, there have been times when corner-cutting has been proposed, or worse, and some folks will not take the word of someone outside of their "area of expertise". But, responding with "Upper Management has said that this is the way we are going to do it. Are you sure you want to be the one who varies?" is the final, use only as a last resort, trump card.

I have only resorted to "this is the standard" a couple of times internally, but ultimately the standard is what we, as QA folks, are held to. To me, covering ourselves with knowledge and application of the standard, however difficult to see on the surface, becomes a matter of survival.

Again, if you are comfortable with another approach, then so be it.
 
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