This gap analysis checklist is prepared for use in evaluating your Quality Management System (QMS) against the requirements of ISO 9001:2015 as you transition from ISO 8001:2008 to ISO 9001:2015. Each requirement is expressed as a question that the user (auditor / assessor) can ask to evaluate your QMS capabilities. You will need to have copies of the ISO 9001:2015 and ISO 9001:2008 standards to use along with this checklist so that you can refer to the requirements if necessary. While the two versions of the standard do not line up when comparing the requirements:

• New requirements and / or new terminology are highlighted in yellow.
• The intent of the main clauses of the new standard is shown in bold blue font.
• The right hand column in green shade is intended to provide reference / comparison / similarities to the ISO 9001:2008 requirements, and to identify and locate where in the new clauses, the former requirements are relevant.
• Comments highlighted in bold red font indicate removed / missing requirements.

After you have prepared an audit schedule, and assigned responsibility to your auditors for different areas or processes to audit, copy each section of the checklist for the auditors working with that section. As you work through the checklist take notes on what is in place, and what needs to be developed. In the space for ‘currently in place’, list or reference the procedures or other documents, or evidence that you have reviewed and that will provide information for the new QMS. Take notes on the status of the documents, that is, will they need to be revised for the new system, or can they be used as is? Also note where processes are in place, but documentation is needed. Focus on what is in place, and what needs to be developed.

While you do want to know if documented information is in place and if procedures and processes are being complied with, compliance is not your main focus for this audit. Remember that the final outcome of this audit should be a list of things that your company needs to do to comply with ISO 9001:2015.