ISO9001 GAP Analysis Question 71 -
Continuous Improvement of the Quality Management System

To determine if the organization has established a process to continually improve the suitability, adequacy, and effectiveness of the Quality Management System (QMS), verify the following areas:

Defined Approach for Improvement:

Check if the organization has identified and documented methods for identifying improvement opportunities in the QMS. This could include procedures for corrective actions, preventive measures, innovation, or reorganization, as well as any specific objectives aimed at enhancing customer satisfaction. Evidence of an established approach to seek and evaluate improvement areas should be present.

Use of Data and Analysis:

Confirm that the organization leverages data from monitoring, measurement, and evaluation activities (e.g., customer feedback, audit results, and performance metrics) to identify improvement opportunities. The organization should be able to provide documented examples showing how data analysis drives decisions for improvements in the QMS.

Management Review and Continual Improvement Plans:

Review the outputs from management review meetings to ensure continual improvement is a standing agenda item. The organization should document any identified improvement actions resulting from these reviews and have a clear plan to address them. Evidence of tracking and completing these actions will indicate compliance with the continual improvement requirement.

Documentation and Evidence of Actions:

Ensure that the organization maintains records that show ongoing improvements to the QMS. This documentation should detail actions taken, results achieved, and any subsequent changes to the QMS to confirm that improvements are implemented and sustained.

These steps will help assess whether the organization has an effective, structured approach to meeting ISO 9001’s continual improvement requirements.