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ISO Prep Checklist?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by MP480, Feb 23, 2017.

?

Did you use a checklist prior to having the audit?

  1. Yes

    50.0%
  2. No

    35.7%
  3. I wish I would have

    7.1%
  4. It's not beneficial enough

    7.1%
  1. MP480

    MP480 Member

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    Okay, so..this may be a dumb question but hey I am just going to throw it out there. Bear with me now..

    Does anyone that has gone through the ISO 9001:2015 certification process have like a basic checklist that they followed? I know that just by going through the ISO standard you can go through and see if you fulfilled the requirement or not. I just didn't know if anyone made like a spreadsheet/checklist that outlines all the ISO requirements that must be fulfilled. We have never been ISO certified and I think it would be nice to have a checklist to review over before moving to the next steps.

    If someone has one, do you mind sharing how you created it? If not then I may just have to buckle down for a few hours and make my own.


    Thanks all! Also, if you don't mind, please fill out the poll as I'm intrigued to see the responses.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I have one which I'll post here in the next day or so. One thought is, since the standard is "light" on "documented procedures" and so on, what I'd suggest is that you go one further than a checklist and create a cross reference matrix, so you can show where, in your QMS, you address various requirements of the ISO standard. This shouldn't be a burden, will help you map the requirements to what you've established and will ease the interface with your auditor.
     
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  3. normzone

    normzone Well-Known Member

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    " do you mind sharing how you created it? If not then I may just have to buckle down for a few hours and make my own. "

    Good luck with the " few hours " part. Since I use this for internal audits, it references previous events that may not be applicable to your new system.

    I parse the text of the standard into smallest appropriate pieces. In a Word doc four cells across I put:

    The element and clause info identifying which part of the standard this little piece references
    The exact language from the standard
    That language carefully translated into people speak, phrased to clearly define the issue as a question, usually requiring objective evidence.
    And the fourth cell is for the answer, as obtained by in depth review of your company's current process state

    The whole thing is preceded by a default page inquiring about inputs/outputs, metrics available, targets, previous nonconformances, etc.
     
  4. RoxaneB

    RoxaneB Moderator Staff Member

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    No, I didn't use a checklist. I had an internal audit (or two) done which identified any remaining gaps with action plans developed to address those gaps. The nature of the gaps was used as our internal go-no/go decision to proceed on with our goal for certification.
     
  5. tony s

    tony s Well-Known Member

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    I don't use a standard checklist (i.e. ISO clause-based) for auditing. But I'm using a blank 3-column table note pad with the following column titles: Audit Criteria, Audit Evidence, Audit Finding. Since I'm comfortable with the "process approach", I only need to include in my note pad the audit criteria that I have chosen to assess (1st column), the evidence/s I have gathered (2nd column) and the result/s of my evaluation (3rd column).
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Do you mean as a list of things to ensure you've covered? Not as an audit checklist, right? Some of us naturally relate "checklist" and "audit", but it occurs to me that you might be looking for a list of things to step through and check off that you've covered the 2015 "bases"...
     
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  7. MP480

    MP480 Member

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    Yes, a cross-referencing matrix is exactly what I need. Thank you for your input Andy Nichols!!!


    Thanks also to normzone: Yes, I need the Standard verbiage broken down in plain English. It's difficult to explain some items to the rest of my management team sometimes and I prefer simple dialect.

    Thanks RoxaneB: We are trying to locate a group within our company to conduct the internal audit. Unfortately, we are running into some issues on availability and someone being ISO 9001 versed.


    Thank you Tony s: I will probably use a similar output for notes but I definitely want to utilize a cross-reference matrix that Andy suggested.
     
    Last edited: Feb 27, 2017
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You might try outsourcing your internal audits. I know of some resources which might work.
     
  9. tony s

    tony s Well-Known Member

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    I just want to share a sample I call "Correlation Matrix". The sample is not complete but you'll get the idea. The matrix demonstrates that all applicable clauses are covered and can be used as the internal auditor's guide in verifying conformance against the relevant ISO 9001 clauses per QMS process. The row that computes the TOTAL shows that only those that are "not applicable clauses" will have a sum of zero and don't need to be verified.
     

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  10. MP480

    MP480 Member

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    That's definitely a possibility if I can't find someone in my corporate.

    Thank you for sharing this sample tony s!
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Please be certain they are available to do audits when you want them to, to respond to perform an audit within a 30 day window and not just once a year...
     
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  12. MP480

    MP480 Member

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    For sure!!
     
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