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ISO 9001:2015 Gap Analysis Checklist

The ISO 9001:2015 Gap Analysis Checklist will enable you to assess your company’s compliance with the ISO 9001:2015 requirements. It contains an explanation of how to use the checklist to document assessment observations, level of compliance and recommendations for improvements.

To view a sample of the 9001:2015 checklist, click on the Demo.  You can purchase the entire checklist for $75.

Gap Analysis Checklist

TQS, Inc. ISO 9001:2015 Gap Analysis Checklist


TQS has prepared this checklist to enable you to assess your current Quality Management system against the ISO 9001:2015 requirements.  It is useful if the user has some level of familiarity the ISO 9001:2015 requirements.  Once the gap analysis is completed, your organization can utilize the results of the analysis to start your transition to comply with the requirements.

 How to Use the Checklist:

The first column of the checklist lists all the ISO 9001:2015 requirements by section number.  The second column of the checklist named “Observations” is used to document what the auditor has observed during the assessment.  The auditor should interview all the processes owners associated with the element.  The auditor should document results of the interviews including any records examined and the results of the examination.

The next two columns are used to indicate the level of compliance with the ISO requirements.  The auditor utilizes the results of the observations to determine the level of compliance with the requirement.  The auditor checks the (NC) nonconformance box if the auditor observed that the process owners were unaware of the requirement, were not following the requirement, or records examined were not consistent with the standards’ record requirements.  If the auditor observed some level of compliant practices, the percent compliant is entered into the (COM) compliant box.

The final column is used to document the auditors recommendations for converting the nonconformances observed during the assessment into compliant practices.  This is a crucial step in the assessment and the recommendations should include best practices along with recommendations obtained from the process owners interviewed.  The auditor should explore current untapped resources including software and informal practices that can be utilized if formalized to comply with the requirements.

  Checklist Price - $75 per download

The ISO 9001:2015 Gap Analysis Checklist is copyright protected but you may use for auditing your company.  It is not to be distributed, modified or sold.  You may add text to the portions where data may be entered, saved and printed.

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Customer TestimonialsCustomer Testimonials

"Thank you for all the information. I found it educational and a valuable tool that will assist me on being a successful internal auditor for our organization."

Tami K. - Completed AS9100 Overview & Internal Auditor Training

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