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Minimum Required Procedures

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Steven Penney, Apr 20, 2016.

  1. Steven Penney

    Steven Penney Member

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    Hi, my background is in ISO 9001:2008. I remember there were a minimum of 6 required procedures, and of course you would add additional as you felt were required. In transitioning to 2015, are these 6 procedures still the minimum required? Or have several been combined? Thanks in advance. Steve
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Steve, if you don't have a copy of the new standard, you're in for a surprise! No required documented procedures! It's up to the organization to decide, through understanding of:
    • The context of the organization
    • Needs of interested parties
    • Internal and external issues
    It shouldn't be, therefore, too difficult to determine what documentation is required to address these things, (not procedures, per se)
     
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  3. tony s

    tony s Well-Known Member

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    According to the ISO 9001:2015 Annex A.6, if the 2008 version used "documented procedures", "quality manual" or "quality plan", the 2015 now defines requirements to "maintain documented information". In addition, the term "records" is now expressed as a requirement to "retain documented information".

    Here's a matrix of the 2015's clauses that define requirements for documented information that is mandatory and as necessary to maintain or retain:
    upload_2016-4-21_8-30-46.png
     
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  4. Steven Penney

    Steven Penney Member

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    Excellent recap of the change in terms and requirements. I see that I will need to spend more time understanding how to stay compliant. Thanks for great information.
     
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  5. tony s

    tony s Well-Known Member

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    You're very welcome Steve.
     
  6. millie5329

    millie5329 Member

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    Hi all good sharing i 'm also ISO 9001: 2008 base, may i know what is the activity or document to be establish to comply the new std.
     
  7. tony s

    tony s Well-Known Member

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    Please refer to the matrix previously provided. You need to have a copy of the ISO 9001:2015 though.
     
  8. MarkMeer

    MarkMeer Well-Known Member

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    It's probably also worth noting that there is no requirement for these all to be necessarily separate documents.

    Given your organization, if it makes sense to combine required procedures into single documents, you can do so. ...if the organization is sufficiently small and simple, you could conceivably meet all requirements within a single document (ala Quality Manuals of old...).
     
  9. millie5329

    millie5329 Member

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  10. SRose

    SRose Member

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    I'm late coming to this thread & this is a very interesting comment. We are transitioning to ISO 2015 from ISO 2008 & I am in the process of producing a new QMS. We are a very small Company with 2 Employees & our 2008 Manual is far too 'big'. I would appreciate, if you have time, if you could give me some pointers on how I could meet all our requirements in 1 document :)
     
  11. SRose

    SRose Member

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    Thank you, I will have a read through our processes & see if I can shorten them, as there is only 2 of us here, it shouldn't be that hard. My Boss does all the manufacturing, the completing of the works job card that shows each process on each item manufactured & the final inspection, I do everything else :)
     
    Last edited by a moderator: Sep 8, 2016

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