Dirkjan Bakker
From a QMS-compliance point of view, executive management or management with executive responsibility is responsible for reviewing the Quality Management System (QMS) at documented planned intervals to ensure periodical evaluation of the QMS on its continuing suitability, adequacy and effectiveness in satisfying the requirements of applicable regulations and standards, customer requirements and QMS-process goals and quality policies in order to determine opportunities for improvement and the need for changes to the QMS, quality policy and quality objectives.
Management review must cover all input required by standards and result in specific documented output.
The Balanced Score Card method of Key Performance Indicators is a recommended tool to define SMART quality (and business) objectives as well as process compliances.
Results of management review may result in recommendations for improvement, in corrections, corrective actions or preventive actions of the QMS or devices. Changes of the QMS need to be assessed in response to applicable new or revised regulatory requirements.
It is highly recommended to systematically address the objectives and management review output, e.g. once per quarter, for proper change management.
Be aware that the management review process including improvement processes always will be addressed by the notified body designated in accordance with that Regulation for the type of device in question and by the FDA per 2 February 2026 as part of their Quality Management System Regulation (QMSR) inspections. For the latter, this is a major change in FDA inspection policies.
Note that also internal quality audit reports, and supplier audit reports will no longer be exempt from inspection by FDA.