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What outcomes are expected from the consideration?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Leonid, Jan 13, 2020.

  1. tony s

    tony s Well-Known Member

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    When no changes are taken to the audit program, must the "evidence of consideration" be made available in a document (e.g. minutes of the meeting)?
     
  2. Leonid

    Leonid Well-Known Member

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    According to 9.2.1 internal audits shall provide information on whether the quality management system is effectively implemented and maintained. “Worsening the effectiveness of processes” is the issue in the indicated context.
     
  3. Leonid

    Leonid Well-Known Member

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    There is no such requirement in the standard. 14k and 45k clarify in section A.3 “The word “consider” means it is necessary to think about the topic but it can be excluded”.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Correct. However, audits do that through confirming a) the QMS process(es) were being followed and b) if the results are valid. Internal audits are not there to "second guess" the management of the process(es) and the measurements.
     
  5. Leonid

    Leonid Well-Known Member

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    I did not get "however". In addition to the conformity issue the internal audit shall provide information whether the quality management system is effectively implemented and maintained. This looks actually as the second check because low effectiveness and poor maintenance indicate needs and expectations are not achieved, i.e. nonconformity.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Internal audits are not just to confirm nonconformity. They are for the purposes of (independent) validation of effectiveness when results are also good/better than expected.
     
  7. Leonid

    Leonid Well-Known Member

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    Auditor validates effectiveness regardless it is good or bad. This will become clear after the validation.