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9.2 Internal audits

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Mehrdad Soltanifar, Apr 7, 2022.

  1. Mehrdad Soltanifar

    Mehrdad Soltanifar Member

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    Hi there,

    We had a stage 2 (ISO 9001:2015) certification audit today. For internal auditing, we have conducted the attached internal audits (half-yearly quality audit & regulatory compliance audit).

    But the auditor was saying that before stage 2, you should have conducted an internal audit (auditees should be the management team) that covers ALL the requirements of the standard from clause 4 to clause 10, everything. He was saying it is mandatory based on 9.2.1.a.2.

    We have scheduled internal audits for this year that covers both our requirements and some of the ISO clauses which will be done throughout the year. But this is the first time I hear that an internal audit of all the clauses should be done before stage 2. Is it true?

    Thanks,
     

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    Mehrdad Soltanifar, Apr 7, 2022
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome Mehrdad!

    Your CB auditor should have verified this at the Stage 1! It's too late to be discussing this at Stage 2! (tell them it's in ISO/IEC 17021!)

    Typically, the CB requires a "full cycle" of internal audits - but no-one can define that. The auditor is wrong to suggest all clauses must be audited in "an audit". All you have to do is demonstrate that you have an effective internal audit process.

    I'd also suggest that at this point in the development of your QMS, doing internal audits half-yearly is a) not going to be effective and b) not meeting the requirements of 9.2 either. You may wish to revisit this. Based on the attachments, I'd also suggest that you shouldn't be doing audits using such a checklist. Although not required, it's fashionable to audit the processes of your QMS and not go through some set of questions based on who knows what? Did you have anyone train your organization on how to do QMS audits? If they did and this is what you are doing, as a result of what you were trained, then you've been ripped off. Sorry to bring bad news.

    So, your auditor is a) incompetent and delinquent (if they did the Stage 1) and you should have been told the expectations BEFORE the Stage 1. Or the auditor should have reported to you that doing no audits before the Stage 2 would results in a (major) non-conformity, and b) inaccurate when they say ALL requirements must be audited. Double check the wording of your agreement/contract with your chosen CB; sometimes, they "slip in" additional requirements to the standard and you might have missed the significance of them, buried in the "small print".

    I'd lodge a complaint with your CB if I were in your shoes!
     
    Last edited: Apr 7, 2022
    Andy Nichols, Apr 7, 2022
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    John C. Abnet likes this.
  3. Mehrdad Soltanifar

    Mehrdad Soltanifar Member

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    Thank you, Andy, for your response.

    Our internal audit program is not limited to half-yearly audits. We have scheduled several (and more comprehensive) internal audits for this year. But only these two internal audits have been conducted so far, as our QMS has been recently developed.

    And the auditor was saying that it's not adequate as we should have conducted an internal audit that "covers all the clauses" of the standard "before stage 2 certification audit".

    As per your suggestion, I've talked to the CB technical manager and he confirmed that there is no such a requirement.

    Thanks,
     
    Mehrdad Soltanifar, Apr 13, 2022
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    RonR Quality Pro and Andy Nichols like this.