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ISO 9001:2015 - Internal Audit

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Faye Inwood, Jan 15, 2017.

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  1. Faye Inwood

    Faye Inwood New Member

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    Good Evening All
    I have got my QMS signed off and will have our stage 2 assessment visit in 2 weeks. I now need to carry out an internal audit of at least one section. Having never carried out an audit before, please can i have some advice on where to start and hows best to do it for ISO 9001?
    Thank you in advance :)
     
    Faye Inwood, Jan 15, 2017
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  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Welcome Faye!

    Do I understand correctly that your site has been declared ready for a certification audit to ISO 9001:2015 without having performed internal audits?

    Or do you mean you have not done any of these audits yourself?

    In either case, what training have you had in performing audits?
     
    Jennifer Kirley, Jan 15, 2017
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes Jennifer's questions are on the money. You did a "stage 1" without doing any internal audits? That means that you didn't do a meaningful management review, either. So, I'd be thinking this: My CB auditor is totally rubbish and I'd stop NOW. Call your CB/Registrar and stop the stage 2. One way or another, this is NOT going to end well. I'd be thinking of asking for my money back and finding a better CB.

    Faye - you didn't get any help with your QMS and no-one suggested an auditor training course?
     
    Andy Nichols, Jan 15, 2017
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  4. MCW8888

    MCW8888 Well-Known Member

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    Welcome to QFO. During my humble beginnings as a Quality Coordinator, I implemented the ISO9001:2008 from scratch but had a mentor who ensured that after Internal Audits and Management Review are completed before going to a stage 1 audit. Also, a pre-assessment was optional for me because I had a mentor. Please abide by the advice of Jennifer and Andy. My own advice is for you to contact your CB to determine if you are ready for stage 1 audit. Hope this helps.
     
    MCW8888, Jan 16, 2017
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  5. tony s

    tony s Well-Known Member

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    If you haven't done an internal audit before to any of your processes, that's a sure Major for a CB audit!:eek:
     
    tony s, Jan 16, 2017
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    A CB - if they did the "stage 1" visit properly, won't have issued a nonconformity about this. They should, by rights, have issued a report citing a concern.

    Did they do that, Faye?
     
    Andy Nichols, Jan 16, 2017
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  7. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    If audits were not done, a site should not be moving to certification stage at all. A CB cannot issue a certificate without audits done. That is why I was wondering (hoping) I did not understand the question correctly.
     
    Jennifer Kirley, Jan 17, 2017
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  8. tony s

    tony s Well-Known Member

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    Carrying out internal audit is best to do before an external audit.;) Before we go for work or a date, would it be better to check ourselves first on a mirror than let somebody notice things that need fixing for us?

    Kidding aside, having never done it, attending at least two days of training with some role playing is helpful.
     
    tony s, Jan 17, 2017
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  9. PSRiordan

    PSRiordan Member

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    Many registrars are giving the okay to move to Stage 2 provided a) there is an plan to conduct an IA of all aspects of the QMS scheduled prior to Stage 2 (client must produce a schedule/agenda/some objective evidence of this) and b) there is evidence of a management review scheduled which will include a review of IA results prior to Stage 2. That's the reality.

    Faye you say you need to conduct an audit of "at least one section." I don't know exactly what that means. Are you one of several auditors who are attempting to get the entire QMS audited prior to Stage 2? Or is your CB saying you can just show evidence that you've started the audit process and have a plan and only have to show evidence of auditing a portion? It's unclear to me.

    If the certification body is allowing you to complete Stage 2 without all processes of the QMS being audited, that's a no-no. I hope that's not the case.
     
    PSRiordan, Jan 19, 2017
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  10. Faye Inwood

    Faye Inwood New Member

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    Dear All
    I am sorry if I am using the incorrect terminology!!
    I am due to have my stage 2 assessment and prior to this I have been asked to carry out an audit of at least one clause as the first section of my audit schedule. Once certified I then have the year to audit all other clauses... Is this correct?
     
    Faye Inwood, Jan 19, 2017
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  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Noooooo! Faye, you've been told the wrong thing and you should delay your audit (stage 2) until you to the following:-

    1. Someone (possibly 2 of you) get some formal internal auditor training (or hire someone like a consultant to do them in the meantime)
    2. Audit your entire management system processes
    3. Take any actions necessary to correct issues found
    4. Prepare an analysis of the audit results for management review
    5. Perform/record a management review to include the audit findings.
    I'd also, in the meantime, critically review your CB's performance and that of your auditor. Unless they have excellent reputation etc find another. Some CBs are NOT following the requirements of ISO/IEC 17021 and their auditors are often not understanding what is supposed to happen at a stage 1.
     
    Andy Nichols, Jan 19, 2017
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  12. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Andy is correct.

    Certificates are not supposed to be issued until the system has been audited. If your registrar has indicated they would accept one (did they say the rest could be handled over time as a long-term action?) the registrar was not behaving as per expectations of at least one accrediting body I know of.

    I also recommend you and hopefully also a helper obtain an accredited Lead Auditor class. Or, one can take Lead Auditor and the other can take Internal Auditor... In any case, someone in control of this process needs to know the requirements.
     
    Jennifer Kirley, Jan 19, 2017
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  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hello Faye: It's been nearly 2 weeks since your post. How have thing been going? Did you do any audits? Did you postpone your stage 2? Please feel free to share...
     
    Andy Nichols, Jan 24, 2017
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  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Of course, we're assuming the CB is accredited under, for example, the UKAS or ANAB (or equivalent to IAF) scheme. I recently discovered that there's a CB in the UK, for example, which appears to be accredited, when in fact they aren't under such a scheme and, their contract is for 10 years! When a client discovers the error of selecting them, they threaten to sue the client for breach.
     
    Andy Nichols, Jan 27, 2017
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  15. tony s

    tony s Well-Known Member

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    Wow! The client should pursue the case. They were made to believe that the CB has the accreditation to operate as such.
     
    tony s, Jan 28, 2017
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  16. Claes Gefvenberg

    Claes Gefvenberg Moderator Staff Member

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    I seem to recall that we have found a couple of those before... In one case the CB and the so called Accreditation company had the same owner.
     
    Claes Gefvenberg, Feb 10, 2017
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  17. Ardaqr

    Ardaqr Member

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    Does anyone have a sample internal audit checklist for the ISO 9001:2015 :)
     
    Ardaqr, Sep 25, 2017
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  18. tony s

    tony s Well-Known Member

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    I don't use a checklist that only transform the requirements of the standard into questions, if that is what you expect for an ISO 9001:2015 checklist. What I've been using is a blank 3-column table form where I list down the criteria that I need to assess (1st column), note the evidences I collected (2nd column) and initially indicate the results of my assessment (3rd column). I manually fill-out this form. At each close of the actual conduct of audit, I provide the auditee with a verbal report using the filled-out form. After the auditee acknowledged my verbal report, I let the auditee sign on this form. The official audit report is then prepared containing the information obtained from this form. See attached document.
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

    tony s, Sep 25, 2017
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  19. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Because the internal audit is supposed to be of your QMS, you should develop your own planning tool/checklist.
     
    Andy Nichols, Sep 25, 2017
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  20. Linah

    Linah Member

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    Is his Audit Notes is enough?
     
    Linah, Nov 15, 2017
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