Management review

Management review is the planned review, by top management, of whether the quality management system is still suitable, adequate and effective.

ISO 13485 clause 5.6 requires the review at documented intervals. Inputs include audit results, feedback, complaint handling, reporting to regulatory authorities, process performance, product conformity, status of corrective and preventive actions, follow-up from previous reviews, changes that could affect the QMS, recommendations for improvement, and applicable new or revised regulatory requirements. Outputs include improvement decisions and resource needs. Records are required.

The meeting fails when the inputs are slides rebuilt from memory. It works when each input is a live view: open CAPAs, audit findings since the last review, complaint trends, supplier re-evaluations that slipped. MDSAP tasks 1.9 and 3.11 sample exactly this.

HAVGATE holds several of those inputs in the audit, CAPA and supplier modules. It does not run the meeting. Export or review the records, write the decisions, and keep the minutes as a controlled record.