This ISO 9001:2015 gap audit checklist is intended to be used as a tool to identify compliance with the differences between ISO 9001:2008 and ISO 9001:2015. This completed checklist would be a supplement to existing ISO 9001:2008 internal audits, since this checklist does not show requirements that are currently contained in ISO 9001:2008. This checklist alone cannot show evidence of compliance with ISO 9001:2008 and ISO 9001:2015; it is only for additional requirements in ISO 9001:2015 that are above and beyond ISO 9001:2008.

The utilization of this checklist, when populated with objective evidence of compliance and non-compliance, will satisfactorily demonstrate you have audited the differences between the 2015 standard versus 2008. It should be used with your certification body as evidence of internal audits to the new ISO 9001:2015 requirements.

It is intentional that this checklist has no page numbers. From a process audit approach, you may wish to rearrange pages from this checklist to group them based on your own QMS processes to demonstrate a process approach. Being a Word document you can change whatever is necessary.

The process audit approach doesn’t want to see questions tied to just a single clause of the standard. It wants to see that you’ve grouped questions from different clauses of the ISO standard against the QMS processes you’ve defined (whatever names you call them). When using this checklist with the Roadmap, you can determine where these requirements apply to your specific processes and process approach. The Roadmap is a simple tool of all the ISO clauses down the left column and all your QMS processes across the top row, then identifying which clauses apply to which processes. When using this checklist, you can determine where these requirements apply to your specific processes and process approach.

The purchase of this gap checklist comes with a free half hour of phone or email consulting. Instructions are sent when purchasing the checklist.