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Quality Management System Review
"I need a Quality Management System Review contract for our pharmaceutical manufacturing facility in Basel, Switzerland, focusing on GMP compliance and ISO 9001:2015 certification preparation, with the review to be completed by March 2025."
1. Parties: Identification of the reviewing organization and the client company, including full legal names, addresses, and registration details
2. Background: Context of the QMS review, including the client's quality management system scope and objectives for the review
3. Definitions: Key terms used throughout the agreement, including technical QMS terminology and contract-specific definitions
4. Scope of Review: Detailed description of what aspects of the QMS will be reviewed, including departments, processes, and documentation
5. Review Methodology: Description of the approach, standards applied (e.g., ISO 9001:2015), and review procedures
6. Timeline and Milestones: Specific dates or timeframes for the review phases, including preparation, on-site review, and reporting
7. Client Obligations: Client's responsibilities including providing access to documentation, facilities, and personnel
8. Reviewer Obligations: Reviewing organization's commitments, including expertise provision and professional standards
9. Confidentiality: Provisions for handling sensitive information encountered during the review
10. Deliverables: Specific outputs to be provided, including reports, presentations, and documentation
11. Fees and Payment: Financial terms, payment schedule, and any additional costs
12. Term and Termination: Duration of the agreement and conditions for early termination
13. Liability and Insurance: Limitations of liability and required insurance coverage
14. General Provisions: Standard legal clauses including governing law, jurisdiction, and entire agreement
1. Follow-up Support: Terms for post-review support and implementation assistance, included when ongoing support is required
2. Training Provisions: Requirements for training staff on findings and improvements, included when training is part of the scope
3. Certification Support: Additional provisions when the review is part of certification preparation
4. Multi-site Provisions: Specific terms for reviews covering multiple locations, included for organizations with multiple facilities
5. Regulatory Compliance: Industry-specific regulatory requirements, included for regulated industries like medical devices or pharmaceuticals
6. Data Protection: Enhanced data protection provisions when significant personal data processing is involved
7. Intellectual Property: IP provisions when the review involves proprietary processes or technology
8. Force Majeure: Provisions for unforeseen circumstances, particularly relevant for long-term or complex reviews
1. Schedule 1: Review Scope Detail: Detailed breakdown of processes, departments, and systems to be reviewed
2. Schedule 2: Review Timeline: Detailed project plan with specific dates and milestones
3. Schedule 3: Fee Schedule: Detailed breakdown of fees, expenses, and payment terms
4. Schedule 4: Required Documentation: List of documents and records the client must provide
5. Schedule 5: Review Team: Qualifications and roles of key review team members
6. Appendix A: Review Methodology: Detailed description of review procedures and standards
7. Appendix B: Report Template: Format and content requirements for the review report
8. Appendix C: Confidentiality Requirements: Detailed confidentiality and data handling procedures
Authors
Applicable Laws
Approved Personnel
Audit Findings
Confidential Information
Corrective Actions
Deliverables
Documentation
Effective Date
Excluded Items
Force Majeure Event
Good Industry Practice
ISO 9001:2015
Key Personnel
Major Non-conformity
Minor Non-conformity
Observation
Quality Management System
Quality Manual
Quality Objectives
Quality Policy
Quality Records
Review
Review Period
Review Plan
Review Report
Review Team
Reviewer
Review Methodology
Scope of Review
Services
Site
Standards
Swiss Quality Standards
Technical Expert
Term
Working Day
Appointment
Scope of Services
Duration
Review Methodology
Quality Standards
Professional Obligations
Client Cooperation
Access Rights
Documentation Requirements
Confidentiality
Data Protection
Intellectual Property
Deliverables
Review Process
Personnel
Fees and Expenses
Payment Terms
Liability and Indemnification
Insurance
Force Majeure
Termination
Non-Solicitation
Assignment
Notices
Governing Law
Dispute Resolution
Entire Agreement
Severability
Amendments
Third Party Rights
Manufacturing
Pharmaceuticals
Medical Devices
Chemical Industry
Food and Beverage
Automotive
Aerospace
Electronics
Healthcare
Information Technology
Construction
Professional Services
Logistics and Supply Chain
Research and Development
Quality Assurance
Operations
Production
Regulatory Affairs
Compliance
Risk Management
Manufacturing
Research and Development
Process Engineering
Quality Control
Technical Operations
Product Development
Supply Chain
Documentation Control
Quality Manager
Operations Director
Compliance Officer
Quality Assurance Specialist
Manufacturing Manager
Plant Manager
Chief Operations Officer
Quality Control Supervisor
Regulatory Affairs Manager
Production Manager
Technical Director
Quality Systems Engineer
Audit Manager
Process Improvement Manager
Quality Coordinator
Risk Management Officer
Senior Quality Consultant
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