The 25 page ISO 9001:2015 Gap Analysis/Internal Audit Checklist contains 313 questions for organizations new and certified to ISO 9001:2015.

After payment has been received, the checklist is sent to you in a Word file for ease of editing.

The checklist header has an area for your company name, logo issue date, gap analysis number, internal audit number, and Standard.

The checklist header also includes columns for Item #, Quality Management System (QMS) Requirements, Yes, No, and Objective Evidence/Comments (e.g., observations, OFIs).

The questions are based on the requirements in ISO 9001:2015.

Interviews during the gap analysis are with the process owners with primary responsibility for the applicable requirements. The conformity level of the process users, (secondary responsibility) are assessed in later internal audits after the system is implemented.

Note: This gap analysis/internal/internal audit checklist can be used to evaluate the current conformity of a quality management system against the requirements of the Standards. Additional criteria for a quality management system may be specified in customer contracts, regulatory documents, and your organization’s own documents, are not considered during a gap analysis These important other requirements should be addressed in later internal audits.

In addition to the checklist/gap analysis above, you will receive an ISO 9001:2008 to ISO 9001:2015 correlation table, an ISO 9001:2015 to ISO 9001:2008 correlation table, an ISO 9001:2015 quick reference guide and an ISO 9001:2015 summary of changes guide.