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Internal Audit - Coverage ISO 9001

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by Padym, Nov 27, 2015.

  1. Padym

    Padym Active Member

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    Kindly guide me the requirement of Internal Audit clause coverage for the period of 3 years as per ISO 9001 2008 standard

    1. Should all the clauses should be covered for each site location (under certification) in the Internal Audit per year or over the period of 3 internal audit cycle

    2. All the clauses should be covered once in 3 year cycle, ensuring each process are covered

    3. System wide process like HR, Measurements, Analysis, should be covered each year.

    Off course based on the risk and importance has to be considered which may effect the frequency for few process.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Your answers are:
    No.
    No.
    No.
     
  3. Padym

    Padym Active Member

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    Thanks Andy. Answer are precise. Would like to add some comments notes.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    OK:
    If there was a requirement for any of these things, it would be IN the standard. Don't forget that ISO 9001 is NOT about certification, so to frame a requirement about certification, relative to ISO 9001 is incorrect. You can comply with ISO 9001 without being certified. Your last question is best answered by understanding (in 2008 version) "status and importance". You can read these words as "risk and impact" - the risk to customer, regulatory compliance and to the bottom line because the status is the process (or other things, like people) etc is under performing, changed, over performing, new or whatever.
     
    MCW8888 likes this.
  5. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Good day Padwym,

    Andy is correct in that there is no clear "shall"; however as you stated, the standard does require scheduling as per status (risk) and importance. I would think that "importance" means critical production processes, inspection and text/calibration and whatever else is critical to you - maybe design. "Status and importance" is based on trends that include changes, and challenges such as high attrition rate for HR. "Results of past audits" of course include previous nonconformances, and OFIs if they are recognized as items that need action.

    I once ran on a 5-year matrix and had a CB auditor write an OFI suggesting we move to a 3-year matrix based on that being our registration cycle. That seemed reasonable to us.

    I hope this helps!
     

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