This document is a checklist designed for conducting a gap analysis based on ISO 9001 standards. It provides a structured approach to assess an organization's quality management system (QMS) by outlining specific criteria across various categories such as context of the organization, leadership, planning, support, operation, performance evaluation, and improvement. Each section contains a series of questions that require a 'Yes', 'No', or 'N/A' response, along with space for comments. The checklist aims to ensure that all relevant external and internal issues are identified, the needs of interested parties are considered, and that the QMS is effectively established, implemented, and maintained. Additionally, it addresses the responsibilities of top management, resource allocation, and the processes required for continual improvement of the QMS. This tool can be utilized on mobile devices for convenience.