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Correcting Audit Findings

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Lindy, Jan 10, 2018.

  1. Andy Nichols

    Andy Nichols Moderator Staff Member

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    What I mean is they treat everything as the tip of the iceberg, instead of allowing simple correction...
     
  2. Golfman25

    Golfman25 Well-Known Member

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    Yep
     
  3. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Ah. I can't speak to IATF requirements. I have been out of that standard for too long. Is the 8D in IATF requirements? Is it in customer requirements?
     
  4. Golfman25

    Golfman25 Well-Known Member

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    I think it was in one of the rules changes they laid out all of the requirements. It pretty much sux.
     
  5. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Why blame the CBs then? We get nonconformities issued if we don't follow IATF rules.
     
  6. BradM

    BradM Moderator Staff Member

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    Hello Lindy! Welcome to the forum.

    I share in your concern. If you are auditing department... Z, and you document non-conformities, I would expect Department Z to own and address those non-conformities. Otherwise, how will they ever own their procedures and their processes?

    I do think you can assist and offer suggestions. However, the quality system needs to be owned by all.

    Years ago at a company I worked at, they failed their first audit under ISO 9001. What the auditor observed was that top management and rank and file workers embraced the quality system, but it appeared middle management had avoided everything all together. QA had written many of the procedures; and several of them not reviewed by management. Many of the management didn't even know what was in the operating procedures; let alone what they were supposed to be doing.

    The smaller the organization, the harder it is to maintain objectivity. But as a general rule the departments need to own their procedures and processes; and address non-conformities addressed during audits. Otherwise you may end up with some pretty, nicely worded procedures than no one follows or understands. :)
     
    Lindy likes this.

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