# Standard Operating Procedure: Management Review

| Document ID | SOP-005 |
|-------------|---------|
| Title | Management Review |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |

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## 1. Purpose

To ensure top management reviews the Quality Management System at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.

## 2. Scope

This procedure applies to the periodic management review of the QMS, including all processes and quality objectives.

## 3. Frequency

Management reviews shall be conducted:
- At least annually
- More frequently if significant changes occur
- As needed based on quality performance

## 4. Responsibilities

### 4.1 Quality Manager
- Prepares management review agenda and materials
- Facilitates the meeting
- Documents meeting minutes and action items
- Tracks completion of action items

### 4.2 Top Management
- Attends management review meetings
- Reviews QMS performance data
- Makes decisions on QMS improvements
- Allocates resources as needed

### 4.3 Department Managers
- Provides input data for their areas
- Attends management review
- Implements assigned action items

## 5. Management Review Inputs

The following shall be considered:

### 5.1 Actions from Previous Reviews
- Status of action items
- Effectiveness of implemented actions

### 5.2 Changes in Context
- Internal changes (organization, resources)
- External changes (regulations, market)

### 5.3 QMS Performance
- Customer satisfaction and feedback
- Quality objectives achievement
- Process performance metrics
- Nonconformities and corrective actions
- Audit results
- Supplier performance

### 5.4 Resource Adequacy
- Personnel
- Infrastructure
- Work environment

### 5.5 Risk and Opportunities
- Risk assessment results
- Effectiveness of risk controls
- New opportunities identified

### 5.6 Improvement Opportunities
- Process improvements
- Product improvements
- QMS enhancements

## 6. Management Review Outputs

Decisions and actions related to:
- Improvement of QMS and processes
- Product improvement
- Resource needs
- Changes to quality policy or objectives

## 7. Documentation

### 7.1 Meeting Minutes
- Date and attendees
- Items discussed
- Decisions made
- Action items with owners and due dates

### 7.2 Record Retention
- Management review records retained for 5 years
- Available for regulatory inspection

## 8. Related Documents

- FRM-008 Management Review Agenda Template
- FRM-009 Management Review Minutes Template

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## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |