An ISO 9001:2015 gap analysis checklist could help you doing this faster. But, you have to have a copy of ISO 9001:2015 standard at hand in order to have adequate understanding regarding the changes in new version before doing gap analysis.
I have made a simple ISO 9001:2015 gap analysis checklist below, which is based on actual gap analysis done in an organization. I hope this will help you upgrading the system faster.
ISO 9001:2015 Gap Analysis Checklist
Use the following ISO 9001:2015 gap analysis checklist to start upgrading your quality management system to the new version.
- Have you determined which clauses in the new version applicable or not applicable in your quality management system?
- Have you determined relevant internal and external issues that affect organization’s ability to achieve goals of your quality management system?
- Have you considered positives and negatives factors or conditions in your internal and external issues?
- Have you considered internal issues related to values, culture, knowledge and performance of organization?
- Have you included issues arising from legal, technological, competitive, market, cultural, social and economic environments (international, national, regional or local) in your external issues?
- Have you reviewed the business process to include all the interested parties?
- Have you trained all of employees about risk assessment?
- Have you made quality policy available to relevant interested parties?
- Have you defined relevant interested parties to your organization?
- Have you evaluated the effectiveness of actions for the risk and opportunities?
- Have you considered risk and opportunities for each process inside your organization?
- Have you determined the knowledge necessary for the operation of its processes and to achieve conformity of products and services?
- Have you identified, verified, protected and safeguarded customer’s or external providers properties that are under the organization’s control or being used by the organization?
- Have you analyzed and evaluated appropriate data and information arising from monitoring, measurement due to effectiveness of actions taken to address risks and opportunities?
- Have you included risks and opportunities into internal audit agenda?
- Have you included change in internal and external issues, performance of external providers, adequacy of resources and the effectiveness of actions taken to address risks and opportunities?
- Have you updated the risks and opportunities after non-conformity occurred?
Get Help in Doing Gap Analysis
If you would like to get help in doing gap analysis of ISO 9001:2015 rather than using the above checklist, of course you can do it. But, additional cost will be required. You have to hire independent auditors or consultants to perform gap analysis.
The auditors who carry out gap analysis will issue gap analysis report. Then, you will need to take actions to fill ‘gaps’ mentioned in the report.