To assess whether the organization has determined the need or opportunities for improvements within its Quality Management System (QMS) and has processes to feed this information into management reviews, review the following:

Examine Records of Data Analysis:

Verify if the organization regularly analyzes data from monitoring and measurement activities, as per clause 9.1.3. This data should be used to identify potential improvements in product conformity, customer satisfaction, QMS performance, and the effectiveness of actions related to risks and opportunities. Confirm that documented evidence exists, such as reports, summaries, or performance review notes, showing these analyses.

Review Evidence of Improvement Initiatives:

Look for documented evidence that identifies specific areas for improvement in the QMS, derived from analysis activities. This may include records of actions taken to enhance processes, address identified risks, or optimize performance based on customer feedback or internal audit findings. Records of past improvement initiatives can also indicate that the organization has a process for identifying and acting on opportunities.

Check Management Review Agendas and Minutes:

Review the agendas and minutes of management review meetings to confirm that opportunities for QMS improvement are a regular agenda item. Management reviews should reference specific areas for improvement identified in the analysis of data and performance metrics. Confirm that these reviews not only discuss performance but also include decisions on how identified improvement needs will be addressed.

Evaluate Integration of Improvement Needs into Strategic Decisions:

Verify that improvement needs identified are linked to broader strategic decisions or resource allocations discussed in management reviews. This would show that the organization has a structured approach for integrating QMS improvement opportunities into its overall planning and resource management, ensuring alignment with organizational goals.

If the organization has processes in place to capture and review improvement needs regularly and feeds these into management reviews, they are likely compliant with the requirements of ISO 9001:2015 for this aspect of clause 9.1.3 and 9.3.