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Step 2b: Conducting the ISO 9001 Gap Analysis

Conduct the Gap Analysis

  • Follow the schedule that you have prepared. Go into each area of the facility to evaluate the current quality system.
  • Focus on what is in place, and what is not in place. Remind auditors that you are not focusing on compliance or non compliance to the current system, but on the design of the current system, and how it matches the ISO 9001 requirements.
  • Take notes on what is in place, and what will need to be developed and changed. Take complete notes, reference documents and examples.
  • Notice where all the processes link to other processes in the organization.
    (Tip: What is a Process Approach?)

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