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Preparation For Upcoming External Audit 13485

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Jimbo11, Sep 3, 2018.

  1. Jimbo11

    Jimbo11 New Member

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    I'm looking for ideas/checklist on how to prepare in advance to run a successful external audit.
     
    Operon_Strategist likes this.
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    it's your first time? What type of audit is it? Do you know what the auditor is going to audit?
     
  3. Jimbo11

    Jimbo11 New Member

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    Andy, I've been through audits in the past. However, I will be the point person this time. Hence, I want to begin preparing now.

    The auditor will be auditing our Quality Systems.

    Jim
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    So is
    Is it a CB audit? Customer audit? Is it a Stage 1, Stage 2, surveillance? Have you got their audit plan?
     

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