This Quality Management System Review document is essential for organizations operating in Malta that need to evaluate and verify their quality management systems' effectiveness and compliance. It is particularly relevant for businesses seeking to maintain ISO certification or those required to demonstrate compliance with EU and Maltese quality standards. The document provides a structured framework for conducting thorough quality system assessments, incorporating requirements from Malta Standards Authority and EU regulations. It outlines the review methodology, documentation requirements, and reporting procedures, while ensuring alignment with both international standards and local Maltese business practices. This agreement is typically used when organizations require independent verification of their quality processes, are preparing for certification/recertification, or need to demonstrate regulatory compliance to Maltese authorities.
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1. Parties: Identification of the reviewing organization and the organization whose QMS is being reviewed
2. Background: Context of the review, including the scope and objectives of the quality management system review
3. Definitions: Key terms used throughout the document, including technical quality management terminology
4. Scope of Review: Detailed description of what aspects of the QMS will be reviewed and any limitations
5. Review Methodology: Description of the approach, standards, and methods used to conduct the review
6. Review Process: Step-by-step outline of how the review will be conducted, including timelines and milestones
7. Responsibilities: Duties and obligations of both parties during the review process
8. Documentation Requirements: List of required documents and records to be provided for the review
9. Confidentiality: Provisions regarding the handling of sensitive information during the review
10. Reporting Requirements: Structure, format, and timeline for delivering review findings and recommendations
11. Follow-up Actions: Process for addressing findings and implementing recommendations
1. Industry-Specific Requirements: Additional requirements specific to regulated industries (include when reviewing QMS in regulated sectors like pharmaceuticals or medical devices)
2. Environmental Management Considerations: Section addressing environmental aspects of the QMS (include when environmental impact is significant to the organization)
3. Risk Assessment: Detailed risk evaluation methodology and criteria (include for high-risk industries or when specifically requested)
4. Compliance Requirements: Specific regulatory compliance aspects (include when operating in heavily regulated industries)
5. Training and Competency: Requirements for reviewer qualifications and expertise (include when specialized knowledge is required)
6. Cost Structure: Detailed breakdown of review costs and payment terms (include when not covered in a separate commercial agreement)
1. Schedule 1 - Review Checklist: Detailed checklist of items to be reviewed within the QMS
2. Schedule 2 - Documentation List: Comprehensive list of required documents and records for review
3. Schedule 3 - Timeline and Milestones: Detailed project plan with specific dates and deliverables
4. Appendix A - Review Templates: Standard templates to be used during the review process
5. Appendix B - Applicable Standards: List of quality standards and regulations applicable to the review
6. Appendix C - Scoring Criteria: Detailed criteria for evaluating different aspects of the QMS
7. Appendix D - Report Format: Template and structure for the final review report
8. Appendix E - Previous Findings: Summary of previous QMS review findings (if applicable)
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