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Quality Management System Review
"I need a Quality Management System Review contract for our pharmaceutical manufacturing facility in Cape Town, with specific focus on ISO 9001:2015 compliance and GMP requirements, planned to commence in March 2025."
1. Parties: Identification of the reviewing organization and the client organization
2. Background: Context of the QMS review, including the client's current certification status and reason for review
3. Definitions: Key terms used throughout the document, including technical QMS terminology
4. Scope of Review: Detailed outline of what aspects of the QMS will be reviewed and any exclusions
5. Review Methodology: The approach and methods to be used in conducting the QMS review
6. Timeline and Milestones: Specific timeframes for different phases of the review process
7. Obligations of the Reviewer: Responsibilities and commitments of the reviewing organization
8. Client Responsibilities: Required cooperation, access, and resources to be provided by the client
9. Deliverables: Specific outputs and reports to be provided as part of the review
10. Confidentiality: Provisions for handling sensitive information accessed during the review
11. Fees and Payment Terms: Cost structure and payment schedule for the review services
12. General Terms: Standard contractual provisions including governing law, notices, and amendment procedures
1. Certification Support: Include when the review is part of certification preparation or maintenance
2. Training Provisions: Include when staff training on findings is part of the scope
3. Remedial Action Plan: Include when the reviewer will assist in developing correction plans
4. Follow-up Review: Include when subsequent reviews are planned to verify improvements
5. Multi-site Provisions: Include when review covers multiple client locations
6. Industry-Specific Requirements: Include when specific industry standards or regulations apply
1. Schedule A - Review Checklist: Detailed checklist of all QMS elements to be reviewed
2. Schedule B - Required Documentation: List of documents and records the client must provide
3. Schedule C - Review Team: Qualifications and roles of review team members
4. Schedule D - Applicable Standards: Specific ISO and industry standards against which the QMS will be reviewed
5. Schedule E - Fee Structure: Detailed breakdown of fees and payment milestones
6. Appendix 1 - Review Templates: Standard forms and templates to be used during the review
7. Appendix 2 - Reporting Format: Template and requirements for the final review report
8. Appendix 3 - Compliance Criteria: Specific criteria used to assess compliance levels
Authors
Manufacturing
Healthcare
Pharmaceutical
Food and Beverage
Automotive
Mining
Construction
Information Technology
Financial Services
Telecommunications
Chemical Processing
Agriculture
Transportation and Logistics
Education and Training
Quality Assurance
Operations
Compliance
Production
Technical Services
Risk Management
Health and Safety
Process Improvement
Senior Management
Audit
Certification
Training and Development
Research and Development
Quality Manager
Quality Assurance Director
Operations Manager
Compliance Officer
Quality Management System Auditor
Technical Director
Production Manager
Chief Operating Officer
Quality Control Supervisor
Risk Manager
Certification Manager
Health and Safety Officer
Process Improvement Manager
Managing Director
Quality Systems Consultant
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