ISO 9001:2015 Clause 9.3 outlines the requirements for management review within a Quality Management System (QMS) in clause 9.3.1 General, clause 9.3.2 Management Review Inputs defines the required inputs to be reviewd in each management review meeting, and clause 9.3.3 Management Review Outputs defines the required outputs or results that need to be retained as documented information.
ISO 9001:2015 Clause 9.3.1 Management Review
Purpose of Management Review: The primary purpose of the management review is to evaluate the performance and effectiveness of the QMS.
Planned Intervals: Management reviews are conducted at planned intervals. The frequency is determined by the organization but is often aligned with the organization's strategic planning and business review cycles.
Clause 9.3.1 Example Software Development Company
Frequency: Management reviews are conducted biannually, aligning with the company's overall strategic planning cycle.
ISO 9001 Clause 9.3.2 Management Review Inputs
Inputs to Management Review: Management reviews are based on a set of inputs, including but not limited to:
Status of Actions: Previous management reviews action item status.
Changes in External and Internal Issues: Updates on changes in the internal and external context that might affect the QMS.
Process Performance and Conformance: Information on how processes are performing against objectives and requirements.
Quality Objective: Status of Quality Objectives performance.
Customer Feedback: Input from customers regarding products, services, and overall satisfaction.
Status of Preventive and Corrective Actions: Progress on addressing non-conformities and taking corrective actions.
Measurement Results: Status of monitoring and measurement.
Results of Audits: Findings from internal and external audits.
External Provider Performance: Suppliers results of nonconformances and corrective actions.
Resources: Highlight of resource shortages in manpower, equipment, or training.
Risk Actions: Effectiveness of actions to address risk and opportunities identified in clause 6.1.
Opportunities for Improvement: Suggestions and opportunities for improving the effectiveness of the QMS.
ISO 9001 Clause 9.3.3 Management Review Outputs
Outputs of Management Review: The management review process produces outputs that typically include decisions and actions related to:
Improvement of the Effectiveness of the QMS: Decisions on how to enhance the QMS based on the review.
Resource Needs: Determining if additional resources are required for the QMS to function effectively.
Policy and Objective Alignment: Ensuring alignment of QMS policies and objectives with organizational goals.
Changes to the QMS: Decisions about changes needed in the QMS to adapt to evolving circumstances.
Continual Improvement: Plans for continual improvement of the QMS.
Documented Information: The results of the management review are documented. This documentation includes the decisions made, actions to be taken, and any changes to the QMS. Note: the minutes of the management review are not required, just the results or decisions made.
ISO 9001:2015 Clause 9.3 Management Review
In summary, ISO 9001:2015 Clause 9.3 ensures that top management regularly evaluates the QMS to drive continual improvement, align it with organizational goals, and respond effectively to changing circumstances.