Management Review Procedure

This procedure defines the requirements for conducting Management Reviews of the Quality Management System to ensure its continuing suitability, adequacy, and effectiveness. Management Review provides top management with the information needed to make informed decisions about QMS improvements, resource allocation, and strategic quality direction.

This procedure applies to all scheduled and unscheduled Management Review meetings. Management Review encompasses the entire Quality Management System including all processes, products, and regulatory requirements within the scope of ISO 13485:2016 certification. Management Review shall be conducted at least twice per year (semi-annually). Additional reviews may be called by the CEO, Management Representative, or Quality Manager in response to significant quality events, regulatory actions, or organizational changes.

Management Representative / Quality Manager: Responsible for scheduling Management Reviews, preparing input data packages, facilitating the meeting, preparing meeting minutes, and tracking action items to completion. Top Management (CEO/President): Required attendee; responsible for making decisions on resource allocation, QMS changes, and strategic quality direction. Department Heads: Contribute input data for their areas, attend the review, and implement assigned action items. Regulatory Affairs: Provide updates on regulatory changes, submissions, and compliance status. All Attendees: Review input materials before the meeting, participate actively, and complete assigned actions.

4.1 Scheduling & Preparation - Management Reviews shall be scheduled at least 4 weeks in advance - The Quality Manager distributes the input data package to all attendees at least 2 weeks before the meeting - Agenda is prepared using the Management Review Agenda Template (FRM-MR-001) 4.2 Required Inputs (per ISO 13485:2016 Clause 5.6.2) The following inputs shall be reviewed at each Management Review: a) Feedback — Customer feedback, complaint trends, and satisfaction data b) Complaint Handling — Summary of complaints received, investigated, and reportable events c) Regulatory Reporting — MDRs, Vigilance reports, and field safety corrective actions d) Audit Results — Internal audit findings and status; external audit results and observations e) Monitoring and Measurement of Processes — Process performance data, KPIs, and yield data f) Monitoring and Measurement of Product — Product quality data, inspection results, release data g) Corrective Actions — CAPA status, effectiveness, and trends h) Preventive Actions — Preventive action status and proactive improvement initiatives i) Follow-up from Previous Reviews — Status of action items from previous Management Reviews j) Changes to the QMS — Planned or needed changes including organizational, regulatory, or process changes k) Recommendations for Improvement — Opportunities identified from any source l) Applicable New or Revised Regulatory Requirements — Changes in standards, regulations, or guidance m) Training — Training compliance metrics, competency gaps, and training plan status 4.3 Meeting Facilitation - The Quality Manager facilitates the meeting using the prepared agenda - Each input is presented, discussed, and documented - Decisions and action items are recorded in real time - Attendance is documented 4.4 Required Outputs (per ISO 13485:2016 Clause 5.6.3) Outputs of Management Review shall include decisions and actions related to: - Improvement of the QMS and its processes - Improvement of product related to customer and regulatory requirements - Changes needed to respond to new or revised regulatory requirements - Resource needs (personnel, equipment, facilities, training budgets) - Updates to quality policy and quality objectives (as needed) 4.5 Meeting Minutes & Action Tracking - Meeting minutes shall be documented using the Management Review Minutes Template (FRM-MR-002) - Minutes include: date, attendees, each input reviewed with summary, decisions made, action items (owner, due date) - Minutes are reviewed and approved by the CEO/President and Quality Manager - Action items are tracked to completion; overdue items are escalated and reviewed at the next Management Review 4.6 Record Retention - Management Review records (minutes, input data packages, presentations) shall be retained per the Record Retention Schedule as quality records

- Management Review Agenda (FRM-MR-001) - Management Review Minutes (FRM-MR-002) - Input data packages and presentations - Action item tracking log - Attendance records

- ISO 13485:2016 Clause 5.6 Management Review - FDA 21 CFR 820.20 Management Responsibility - Quality Manual (QM-001) - All referenced SOPs providing input data