ISO 9001:2015 Clause 9.3.3 specifies the outputs or outcomes that should result from the management review process of the Quality Management System (QMS). These outputs are essential for ensuring continuous improvement and for making decisions that can enhance the effectiveness of the QMS. The clause mandates that the outputs of the management review include decisions and actions related to:
-
Improvement of the QMS and Its Processes: Identifying opportunities and implementing actions to improve the overall performance and effectiveness of the QMS. This includes enhancing processes to better meet customer requirements and the organization's quality objectives.
-
Improvement of Products and Services: Focusing on the enhancement of products and services to increase customer satisfaction. This involves addressing issues identified through the review of customer feedback and product performance data.
-
Resource Needs: Evaluating and addressing the need for resources, including human resources, technological resources, and infrastructure. Ensuring that the organization has the necessary resources to achieve its objectives is critical for the effectiveness of the QMS.
-
Actions to Address Risks and Opportunities: Based on the risk-based thinking approach of ISO 9001:2015, management review outputs should include decisions regarding actions to address identified risks and opportunities. This is to ensure the QMS can achieve its intended results, prevent or reduce undesired effects, and achieve continual improvement.
The clause emphasizes that the organization must retain documented information as evidence of the results of management reviews. This documentation ensures that there is a record of what was decided, what actions need to be taken, who is responsible for these actions, and the deadlines for their completion.
Overall, Clause 9.3.3 aims to ensure that the management review process leads to actionable decisions that improve the QMS's ability to meet requirements and enhance customer satisfaction. It underscores the importance of top management's involvement in the QMS's continual improvement, ensuring the organization remains responsive to changes in internal and external conditions.