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Interesting Topic Potential Issues for Auditing ISO 9001:2015

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#81
Clause 7.5.3.2c mentioned: "the organization shall address the following activities, as applicable... control of changes (e.g. version control)"

The manual here is on its initial release and hasn't been revised, thus the auditee can assert that they deemed "not applicable". The primary intention of the clause statement is "control of changes" and not "version control" - that's why it is enclosed as an exempli gratia (for example). The manual may not have a document number/code and a version number but other means of knowing whether the manual is the current one can be verified by a competent auditor. Exempli gratia:
  • first, ask the manager, or QMR or the document controller if there are other versions of the manual;
  • or ask if the manual is the latest version;
  • if in doubt or you don't trust any of the three auditee:
    • compare the copy held by the auditor with the other copies;
    • if the document controller maintains the master, compare it with the master;
    • if it doesn't have a version number, look for its date of issue to compare with the other copies
These are all excellent questions for follow up when in the process audit. They are the sorts of questions I would ask in order to determine if the dcument is current.

I do feel the need to point out the standard's exact wording of 7.5.3.2c: "control of changes (e.g. version control)" so I do not feel free to interpret further.

The question I had (as yet unanswered) was how the organization's user would know if the document (we're talking process now, unless this manual is the sole example) is current. I was not told that the manual had a date, which would work fine. I am asking the question from the perspective of the user. What is the process? Is it effective?
 

tony s

Information Seeker
Trusted
#82
I do feel the need to point out the standard's exact wording of 7.5.3.2c: "control of changes (e.g. version control)" so I do not feel free to interpret further.
Auditors, of course, are not prohibited to interpret the standards. What is actually prohibited is when an auditor evaluate an auditee's interpretation against his/her own interpretation. The approach of the auditee should be evaluated against the intention of the requirements of the standard.

Should we need to interpret the standard, the entire sentence, or even paragraph, should be taken to set the intent of the requirement - the reason I have to highlight the relative phrase "as applicable". My understanding is that whenever we, as auditors, encounter such relative phrases or weasel words (as per Big Jim) i.e. "as/where applicable", "as necessary", "as appropriate" - it's left to the organization/auditee to determine "applicability", "necessity", and "appropriateness".
 

somashekar

Staff member
Super Moderator
#83
Auditors, of course, are not prohibited to interpret the standards. What is actually prohibited is when an auditor evaluate an auditee's interpretation against his/her own interpretation. The approach of the auditee should be evaluated against the intention of the requirements of the standard.

Should we need to interpret the standard, the entire sentence, or even paragraph, should be taken to set the intent of the requirement - the reason I have to highlight the relative phrase "as applicable". My understanding is that whenever we, as auditors, encounter such relative phrases or weasel words (as per Big Jim) i.e. "as/where applicable", "as necessary", "as appropriate" - it's left to the organization/auditee to determine "applicability", "necessity", and "appropriateness".
As an auditor you have all the resources and rights to ask and gather the information or documentation by way of which the organization deemed it not applicable.
 

tony s

Information Seeker
Trusted
#84
As an auditor you have all the resources and rights to ask and gather the information or documentation by way of which the organization deemed it not applicable.
Yes we can challenge their decision. But, we have to see their decision and the associated approach first.
 

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