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Quality Management System Review
"I need a Quality Management System Review agreement for my pharmaceutical manufacturing company in Malaysia, focusing on ISO 9001:2015 compliance and including specific provisions for GMP requirements, scheduled to commence in March 2025."
1. Parties: Identification of the reviewing organization and the client company
2. Background: Context of the QMS review, including current certification status and review objectives
3. Definitions: Key terms used in the agreement, including specific quality management terminology
4. Scope of Review: Detailed outline of the QMS review scope, including departments, processes, and systems to be reviewed
5. Review Methodology: Description of the review approach, standards to be applied, and assessment criteria
6. Obligations of the Reviewer: Responsibilities and commitments of the reviewing organization
7. Client Responsibilities: Obligations of the client organization, including provision of access and information
8. Timeline and Milestones: Schedule of the review process, including key dates and deliverables
9. Fees and Payment Terms: Financial terms, payment schedule, and any additional costs
10. Confidentiality: Provisions for handling confidential information and compliance with PDPA
11. Reporting Requirements: Format, content, and delivery of review findings and recommendations
12. Term and Termination: Duration of the agreement and conditions for termination
13. General Provisions: Standard legal clauses including governing law, notices, and dispute resolution
1. Certification Support: Include when the review is part of preparation for formal certification
2. Training Provisions: Add when the scope includes staff training on quality management
3. Corrective Action Support: Include when post-review implementation support is required
4. International Standards Compliance: Add for organizations requiring compliance with specific international standards
5. Industry-Specific Requirements: Include when the client operates in regulated industries with specific quality requirements
6. Remote Review Provisions: Add when part of the review will be conducted remotely
7. Data Protection and Transfer: Include when review involves processing or transfer of personal data
1. Schedule 1: Review Scope Matrix: Detailed breakdown of departments, processes, and systems to be reviewed
2. Schedule 2: Review Timeline: Detailed project plan with specific dates and milestones
3. Schedule 3: Fee Structure: Detailed breakdown of fees, payment schedules, and additional costs
4. Schedule 4: Required Documentation: List of documents and records to be provided by the client
5. Schedule 5: Review Team: Details of review team members and their qualifications
6. Appendix A: Review Methodology: Detailed description of review procedures and assessment criteria
7. Appendix B: Reporting Templates: Standard formats for various reports and documentation
8. Appendix C: Relevant Standards: List of applicable Malaysian and international standards
9. Appendix D: Confidentiality Agreement: Detailed confidentiality and non-disclosure terms
Authors
Manufacturing
Healthcare
Pharmaceuticals
Food and Beverage
Electronics
Automotive
Aerospace
Construction
Information Technology
Financial Services
Education
Logistics and Supply Chain
Chemical Industry
Medical Devices
Telecommunications
Quality Assurance
Operations
Production
Compliance
Risk Management
Manufacturing
Research and Development
Supply Chain
Process Engineering
Regulatory Affairs
Technical Operations
Quality Control
Continuous Improvement
Documentation Control
Quality Manager
Operations Director
Compliance Officer
Chief Operating Officer
Quality Assurance Manager
Production Manager
Quality Control Supervisor
Regulatory Affairs Manager
Plant Manager
Technical Director
Quality Systems Auditor
Process Improvement Manager
Manufacturing Manager
Supply Chain Manager
Risk Management Officer
Quality Engineering Manager
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