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Scheduling and Conducting the ISO 9001 Gap Analysis

A. Schedule the Gap

  1. Review the project plan:
    • Who did you identify to conduct the gap?
    • Schedule the Gap Analysis, and communicate to all employees what is being done, and why. You will want to be able to make the employees comfortable with answering your auditor's questions.
    • You may want to consider sending out a newsletter to inform employees that the Gap will be performed, by whom, when and why the Gap is being performed. Use the Employee Newsletter #2 at the end of this Quick Start Kit.
  2. The audit schedule
    • Determine if you will audit by process/procedure or by area of the facility. Our approach is usually to audit by area of the facility.
    • Divide the facility into manageable areas.
    • Schedule time to audit each section of the standard that applies to the area.
    • If you are using an audit team, assign the team to cover the various areas of the facility.
    • Arrange your Gap Analysis checklists so each auditor will have the sections of the standard that are applicable in the areas they will cover.
    • Arrange your checklists so each auditor will have the sections of the standard that are applicable in the areas they will cover.

B. Conducting the Audit

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 9001:2000 requirements.
  • Take notes on what is in place, and what will need to be developed and changed. Take complete notes, reference documents and examples.

C. Reporting

Summarize the audit findings in the form of a task list. You will usually identify several categories of tasks.

  • Processes that comply with the standard and are documented.
  • Processes that comply with the standard and must be documented.
  • Processes that do not comply with the standard and must be redesigned.
  • Processes required by the standard that are not currently in place.
  • For each requirement (or set of requirements) of the standard you will want to identify the status of the current system. The ISO 9001:2000 Steering Team will use this information as they assign responsibility and timelines to Teams. Task Teams will be assigned responsibility for development of a procedure.

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