Ensure your Quality Management System remains fit for purpose, effective, and continuously improving with this structured Management Review Procedure. Designed to satisfy the management review requirements of ISO 13485:2016 and ISO 9001:2015, this procedure defines a clear, repeatable process for conducting reviews of your QMS at planned, documented intervals — giving Top Management the framework they need to fulfil one of their most critical quality governance responsibilities.

The procedure goes beyond simply scheduling a meeting. It provides comprehensive guidance for the planning, execution, and documentation of management review meetings, ensuring that every review is conducted consistently, that the right subjects are addressed, and that outcomes are properly recorded and actioned. By establishing a disciplined review cadence, organisations can maintain ongoing confidence that their QMS continues to be suitable and adequate for the organisation's context, and effective in delivering the quality outcomes it is designed to achieve.

A key function of the management review process is its forward-looking dimension. In addition to evaluating current QMS performance, the procedure prompts leadership to actively assess opportunities for improvement and identify the need for changes — including, where appropriate, revisions to the Quality Policy and Quality Objectives themselves. This ensures the QMS evolves in response to changing business conditions, customer requirements, regulatory developments, and performance data, rather than becoming a static set of documents disconnected from operational reality.

Whether you are implementing a management review process for the first time or formalising an existing approach to meet certification requirements, this procedure provides the clarity, structure, and documentation framework your organisation needs to conduct reviews that are meaningful, compliant, and genuinely value-adding.

Comes with a FREE training effectiveness evaluation assessment!