Management Review Guide

Management Review Guide

ISO 13485 Clause 5.6 management review requirements, inputs, outputs, and action tracking.

Table of Contents

• Review Requirements
• Required Inputs
• Review Agenda
• Required Outputs
• Action Tracking
• Documentation Templates

Review Requirements

ISO 13485:2016 Clause 5.6

Review Schedule

Planning Checklist

• Review date scheduled and communicated
• Previous review actions status updated
• All input data collected and analyzed
• Presentation/report prepared
• Attendee availability confirmed
• Meeting room and resources arranged
• Agenda distributed 1 week in advance

Required Inputs

ISO 13485 Required Input Topics

Input Data Collection Template

MANAGEMENT REVIEW INPUT SUMMARY

Review Period: [Start Date] to [End Date]
Prepared By: [Name]
Date Prepared: [Date]

1. AUDIT RESULTS
Internal Audits Completed: [Number]
External Audits Completed: [Number]
Major Findings: [Number] | Minor Findings: [Number]
Open Audit Actions: [Number]
Summary: [Brief narrative]

2. CUSTOMER FEEDBACK
Total Complaints: [Number]
Complaint Rate: [X per 1000 units]
Customer Satisfaction Score: [Score]
Top Complaint Categories:
- [Category 1]: [Count]
- [Category 2]: [Count]
Trend: [Improving/Stable/Declining]

3. PROCESS PERFORMANCE
| Process | Target | Actual | Status |
|---------|--------|--------|--------|
| [Process 1] | [Target] | [Actual] | [Met/Not Met] |

4. PRODUCT CONFORMITY
First Pass Yield: [%]
Nonconformance Rate: [%]
Reject/Scrap Cost: [$]
Top NC Categories:
- [Category 1]: [Count]

5. CAPA STATUS
Open CAPAs: [Number]
Overdue CAPAs: [Number]
Effectiveness Rate: [%]
Average Closure Time: [Days]

6. PREVIOUS ACTIONS
Total Actions from Last Review: [Number]
Completed: [Number] | In Progress: [Number] | Overdue: [Number]

7. QMS CHANGES
Regulatory Changes: [List]
Standard Updates: [List]
Internal Changes: [List]

8. RECOMMENDATIONS
[List improvement opportunities collected]

Data Analysis Guidelines

Review Agenda

Standard Agenda Template

MANAGEMENT REVIEW AGENDA

Date: [Date]
Time: [Start] - [End]
Location: [Room/Virtual Link]
Chair: [QMR Name]

1. OPENING (10 min)
   - Call to order and attendance
   - Approval of previous meeting minutes
   - Review of previous action items

2. QMS PERFORMANCE (30 min)
   - Audit results summary
   - Process performance metrics
   - Product conformity data
   - Customer feedback analysis

3. COMPLIANCE STATUS (20 min)
   - Regulatory compliance status
   - Certification status
   - Changes affecting QMS

4. CAPA AND IMPROVEMENT (20 min)
   - CAPA status and trends
   - Improvement initiatives status
   - Recommendations for improvement

5. RESOURCE REVIEW (15 min)
   - Resource adequacy assessment
   - Training and competency status
   - Infrastructure needs

6. STRATEGIC ITEMS (15 min)
   - Quality objectives progress
   - Quality policy adequacy
   - Strategic quality initiatives

7. DECISIONS AND ACTIONS (15 min)
   - Decisions required
   - New action items
   - Next review planning

8. CLOSING (5 min)
   - Summary of decisions
   - Action item review
   - Adjournment

Time Allocation by Review Type

Required Outputs

ISO 13485 Required Output Topics

Output Documentation Template

MANAGEMENT REVIEW OUTPUTS

Review Date: [Date]
Review Type: [Annual/Semi-annual/Quarterly]

DECISIONS MADE:

1. QMS IMPROVEMENT DECISIONS
| Decision | Rationale | Owner | Due Date |
|----------|-----------|-------|----------|
| [Decision 1] | [Why] | [Who] | [When] |

2. RESOURCE DECISIONS
| Decision | Resources Required | Budget Impact | Owner |
|----------|-------------------|----------------|-------|
| [Decision 1] | [What needed] | [$] | [Who] |

3. QUALITY OBJECTIVES
| Objective | Current | Target | Change | Rationale |
|-----------|---------|--------|--------|-----------|
| [Objective 1] | [Current target] | [New target] | [+/-] | [Why] |

4. QMS CHANGES APPROVED
| Change | Scope | Implementation Date | Owner |
|--------|-------|---------------------|-------|
| [Change 1] | [Affected areas] | [Date] | [Who] |

CONCLUSIONS:
- Overall QMS effectiveness: [Effective/Needs Improvement]
- Quality policy adequacy: [Adequate/Needs Update]
- Quality objectives progress: [On Track/Behind/Ahead]

NEXT REVIEW:
Date: [Date]
Special Focus Areas: [Areas requiring attention]

Action Tracking

Action Item Format

ACTION ITEM

ID: MR-[Year]-[Number]
Source: Management Review [Date]
Category: [ ] Improvement [ ] Resource [ ] Compliance [ ] Other

Description: [Specific action to be taken]
Owner: [Name, Title]
Due Date: [Date]
Priority: [ ] High [ ] Medium [ ] Low

Success Criteria: [How completion will be verified]
Resources Required: [People, budget, equipment]
Dependencies: [Other actions or conditions]

Status Updates:
| Date | Update | Updated By |
|------|--------|------------|
| [Date] | [Progress note] | [Name] |

Completion:
Completed Date: [Date]
Evidence: [Reference to evidence of completion]
Verified By: [Name, Date]

Action Status Categories

Action Tracking Dashboard

MANAGEMENT REVIEW ACTION TRACKER

Review: [Date]
Last Updated: [Date]

SUMMARY:
Total Actions: [Number]
| Status | Count | % |
|--------|-------|---|
| Complete/Verified | [N] | [%] |
| In Progress | [N] | [%] |
| Not Started | [N] | [%] |
| Overdue | [N] | [%] |
| On Hold | [N] | [%] |

OVERDUE ACTIONS (Requires Escalation):
| ID | Description | Owner | Due Date | Days Overdue |
|----|-------------|-------|----------|--------------|
| [ID] | [Brief] | [Name] | [Date] | [Days] |

UPCOMING DUE (Next 30 Days):
| ID | Description | Owner | Due Date |
|----|-------------|-------|----------|
| [ID] | [Brief] | [Name] | [Date] |

Documentation Templates

Meeting Minutes Template

MANAGEMENT REVIEW MEETING MINUTES

Date: [Date]
Time: [Start] - [End]
Location: [Location]
Chair: [Name]
Recorder: [Name]

ATTENDEES:
| Name | Title | Present |
|------|-------|---------|
| [Name] | [Title] | ☑ Yes / ☐ No |

AGENDA ITEMS REVIEWED:

1. [Topic]
   Discussion: [Summary of discussion]
   Decision: [Decision made, if any]
   Action: [Action assigned, if any]

2. [Topic]
   ...

DECISIONS SUMMARY:
1. [Decision 1]
2. [Decision 2]

ACTIONS ASSIGNED:
| ID | Action | Owner | Due Date |
|----|--------|-------|----------|
| MR-XX-01 | [Action] | [Name] | [Date] |

NEXT MEETING:
Date: [Date]
Preliminary Agenda Items: [Topics to cover]

APPROVAL:
Chair: _________________ Date: _______
QMR: _________________ Date: _______

Review Effectiveness Metrics