2.7 KiB
2.7 KiB
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 |
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
Revision History
| Rev | Date | Description | Author |
|---|---|---|---|
| 1.0 | [DATE] | Initial release | [AUTHOR] |