The Quality Management System Review is a critical document used when organizations need to assess their quality management systems' effectiveness and compliance with Australian standards and regulations. It is typically required during annual internal audits, preparation for external certification, or when significant organizational changes occur. The review examines all aspects of the quality management system, including documentation, processes, procedures, and actual implementation. It incorporates requirements from AS/NZS ISO 9001:2016 and other relevant Australian standards, while also considering industry-specific regulations. The document serves multiple purposes: demonstrating regulatory compliance, identifying areas for improvement, providing actionable recommendations, and supporting strategic decision-making for quality management enhancement.
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1. Parties: Identification of the reviewing organization and the organization being reviewed
2. Background: Context of the review, including scope, objectives, and relevant organizational information
3. Definitions: Key terms and abbreviations used throughout the document
4. Executive Summary: Overview of key findings, major non-conformances, and critical recommendations
5. Review Methodology: Description of the approach, tools, and techniques used in conducting the review
6. Current System Overview: Description of the existing quality management system and its components
7. Findings and Observations: Detailed analysis of the QMS, including conformances and non-conformances
8. Risk Assessment: Evaluation of risks identified in the current system
9. Recommendations: Specific actions recommended for improvement, prioritized by importance
10. Implementation Timeline: Proposed schedule for implementing recommended changes
11. Conclusion: Summary of key points and overall assessment of the QMS
1. Cost Analysis: Financial implications of implementing recommended changes - include when cost is a significant factor in decision-making
2. Regulatory Compliance Review: Detailed assessment of compliance with specific regulations - include for heavily regulated industries
3. Training Requirements: Analysis of training needs for implementing changes - include when significant system changes are recommended
4. Benchmarking Analysis: Comparison with industry standards or competitors - include when competitive positioning is important
5. Change Management Plan: Detailed plan for managing organizational changes - include for major system overhauls
6. Stakeholder Impact Analysis: Assessment of how changes will affect different stakeholders - include for large organizations
1. Schedule A - Review Checklist: Detailed checklist used during the review process
2. Schedule B - Audit Findings Matrix: Detailed matrix of all findings categorized by severity and area
3. Schedule C - Process Maps: Current and proposed process flow diagrams
4. Schedule D - Data Analysis: Statistical analysis and metrics from the review
5. Appendix 1 - Interview Records: Summary of key stakeholder interviews
6. Appendix 2 - Document Register: List of all documents reviewed during the assessment
7. Appendix 3 - Non-Conformance Reports: Detailed reports of all non-conformances identified
8. Appendix 4 - Photographic Evidence: Visual documentation of findings where applicable
Relevant legal definitions
Clauses
Relevant Industries
Manufacturing
Healthcare
Pharmaceuticals
Food and Beverage
Aerospace
Automotive
Construction
Technology
Education
Professional Services
Mining
Chemical Processing
Medical Devices
Logistics and Supply Chain
Research and Development
Relevant Teams
Quality Assurance
Quality Control
Operations
Production
Compliance
Risk Management
Senior Management
Process Engineering
Manufacturing
Research and Development
Regulatory Affairs
Internal Audit
Technical Operations
Relevant Roles
Quality Manager
Quality Assurance Director
Compliance Officer
Operations Manager
Production Manager
Quality Control Supervisor
Chief Quality Officer
Quality Systems Auditor
Process Improvement Manager
Regulatory Affairs Manager
Quality Engineer
Manufacturing Manager
Technical Director
Chief Operations Officer
Risk Manager
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