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Management Review Policy
"I need a Management Review Policy for a medium-sized pharmaceutical manufacturing company in Ireland that complies with both ISO 9001:2015 and EU GMP requirements, with particular emphasis on product quality and safety review procedures."
1. Purpose and Scope: Defines the objective of the policy and its applicability within the organization
2. Policy Statement: Clear statement of the organization's commitment to regular management reviews and continuous improvement
3. Definitions: Key terms used throughout the policy document
4. Roles and Responsibilities: Defines who is responsible for conducting, participating in, and following up on management reviews
5. Frequency of Reviews: Establishes the required intervals for management reviews and circumstances requiring additional reviews
6. Review Input Requirements: Lists the mandatory information and data to be reviewed during management meetings
7. Review Process: Step-by-step procedure for conducting management reviews
8. Documentation Requirements: Specifies how review meetings should be documented and records maintained
9. Follow-up Actions: Process for tracking and implementing actions arising from management reviews
10. Compliance and Reporting: Requirements for ensuring compliance with relevant legislation and internal reporting procedures
1. Integration with Other Management Systems: Section for organizations with multiple management systems (e.g., ISO 9001, ISO 14001) to describe how reviews are integrated
2. Remote Review Procedures: For organizations with remote workers or multiple locations, describing virtual review processes
3. Industry-Specific Requirements: Additional requirements specific to regulated industries or sectors
4. Stakeholder Communication: Procedures for communicating review outcomes to relevant stakeholders
5. Risk Assessment Integration: For organizations with formal risk management processes, describing how risks are reviewed
6. Performance Metrics: Detailed section on specific KPIs and performance measures for organizations with complex monitoring needs
1. Schedule 1: Management Review Agenda Template: Standard agenda template for management review meetings
2. Schedule 2: Review Input Checklist: Checklist of required information and data for review meetings
3. Schedule 3: Action Item Template: Template for documenting and tracking action items from reviews
4. Schedule 4: Performance Metrics Template: Standard template for reporting key performance indicators
5. Appendix A: Meeting Minutes Template: Template for documenting management review meetings
6. Appendix B: Annual Review Calendar: Template for scheduling regular reviews throughout the year
7. Appendix C: Regulatory Compliance Checklist: Checklist ensuring reviews comply with relevant Irish legislation
Authors
Manufacturing
Healthcare
Financial Services
Technology
Retail
Education
Professional Services
Construction
Pharmaceutical
Food and Beverage
Transportation and Logistics
Public Sector
Telecommunications
Energy and Utilities
Senior Leadership
Quality Assurance
Compliance
Operations
Human Resources
Risk Management
Internal Audit
Legal
Health and Safety
Information Technology
Project Management Office
Business Development
Production
Research and Development
Chief Executive Officer
Managing Director
Quality Manager
Compliance Officer
Operations Director
Human Resources Director
Department Manager
Risk Manager
Audit Manager
Quality Assurance Lead
Operations Manager
Project Manager
Compliance Manager
Business Unit Head
General Manager
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