Information
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Document No.
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Audit Title
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
Opening Meeting & Position
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Introductions
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Purpose and scope
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Explanation of methods and types of non-conformanceA
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Area of work and access to the system
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Confidentiality
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Daily update and closing meeting times
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Changes since the last audit
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Number of full time employees
Previous Non-conformances
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Previous non-conformances and actions
Previous Observations
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Previous observations and actions
Previous Improvement Opportunities
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Previous improvement opportunities and actions
4.1 General Requirements
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Area audited and evidence
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Requirements
- Manual established - YES
- Manual established - NO
- Scope defined - YES
- Scope defined - NO
- Exclusions listed - YES
- Exclusions listed - NO
- Required documented procedures - YES
- Required documented procedures - NO
- Interaction defined - YES
- Interaction defined - NO
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
4.2 Documentation
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Area audited and evidence
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Documents
- Document control procedure - YES
- Document control procedure - NO
- Approval process - YES
- Approval process - NO
- Review process - YES
- Review process - NO
- Change identification - YES
- Change identification - NO
- Available to staff - YES
- Available to staff - NO
- Identifiable & legible - YES
- Identifiable & legible - NO
- Obsolete documents identified & prevented from use - YES
- Obsolete documents identified & prevented from use - NO
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Records
- Records identified - YES
- Records identified - NO
- Appropriate storage - YES
- Appropriate storage - NO
- Protection - YES
- Protection - NO
- Retrieval - YES
- Retrieval - NO
- Retention - YES
- Retention - NO
- Disposal - YES
- Disposal - NO
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
5.1 Management Commitment
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Area audited and evidence
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Requirements
- Quality Policy in place - YES
- Quality Policy in place - NO
- Quality Objectives established - YES
- Quality Objectives established - NO
- Management Reviews conducted - YES
- Management Reviews conducted - NO
- Importance of compliance conveyed t staff - YES
- Importance of compliance conveyed to staff - NO
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
5.2 CUSTOMER FOCUS
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Area audited and evidence
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Requirements
- Customer requirements determined - YES
- Customer requirements determined - NO
- Customer requirements met - YES
- Customer requirements met - NO
- Customer service enhanced - YES
- Customer service enhanced - NO
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
5.3 Quality Policy
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Area audited and evidence
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Requirements
- Appropriate - YES
- Appropriate - NO
- Comply with requirements - YES
- Comply with requirements - NO
- Continual improvement - YES
- Continual improvement - NO
- Framework for objectives - YES
- Framework for objectives - NO
- Review - YES
- Review - NO
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
5.4 QUALITY PLANNING
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Area audited and evidence
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Objectives
- Measureable - YES
- Measureable - NO
- Consistent with Policy - YES
- Consistent with Policy - NO
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Planning
- Audits and reviews planned - YES
- Audits and reviews planned - NO
- Need for procedures identified - YES
- Need for procedures identified - NO
- Change management - YES
- Change management - NO
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
5.5 Responsibility, Authority, Communication
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Area audited and evidence
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Requirements
- Management Representative - YES
- Management Representative - NO
- Responsible for the System - YES
- Responsible for the System - NO
- Reporting to Top Management - YES
- Reporting to Top Management - NO
- Promotion of "CUSTOMER" requirements - YES
- Promotion of "CUSTOMER" requirements - NO
- Communication of effectiveness of the system - YES
- Communication of effectiveness of the system - YES
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
5.6 MANAGEMENT REVIEW
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Area audited and evidence
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Requirements INPUTS
- Results of Audits - YES
- Results of Audits - NO
- Customer feedback - YES
- Customer feedback - NO
- Process performance and conformity - YES
- Process performance and conformity - NO
- CAPA status - YES
- CAPA status - NO
- Follow-up actions - YES
- Follow-up actions - NO
- Changes that could affect the system - YES
- Changes that could affect the system - NO
- Recommendations for improvement - YES
- Recommendations for improvement - NO
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Requirements OUTPUTS
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
6.1 PROVISION OF (quality) RESOURCES
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Area audited and evidence
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Requirements
- QM resources adequate - YES
- QM resources adequate - NO
- QM competency adequate - YES
- QM competency adequate - NO
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
6.2 Human Resources
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Area audited and evidence
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Requirements
- Competence determined - YES
- Competence determined - NO
- Training requirements identified and delivered - YES
- Training requirements identified and delivered - YES
- Evaluation of effectiveness - YES
- Evaluation of effectiveness - NO
- Staff awareness - YES
- Staff awareness - NO
- Records maintained - YES
- Records maintained - NO
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
6.3 Infrastructure
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Area audited and evidence
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Requirements
- Suitable workspace - YES
- Suitable workspace - NO
- Process equipment appropriate - YES
- Process equipment appropriate - NO
- Support services appropriate - YES
- Support services appropriate - NO
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
6.4 Work Environment
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
7.1 Planning of Product Realisation
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Area audited and evidence
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Requirements
- Quality objectives and requirements for product - YES
- Quality objectives and requirements for product - NO
- Delivery process established - YES
- Delivery Process established - NO
- Required verification processes in place - YES
- Required verification processes in place - NO
- Required records identified - YES
- Required records identified - NO
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
7.2 Customer Related Processes
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Area audited and evidence
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Requirements - Determination of Requirements
- Customer requirements captured - YES
- Customer requirements captured - NO
- Implied requirements identified - YES
- Implied requirements identified - NO
- Statutory & regulatory requirements identified - YES
- Statutory & regulatory requirements identified - NO
- Organisational requirements identified - YES
- Organisational requirements identified - NO
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Requirements - Review of Requirements
- Requirements defined - YES
- Requirements defined - NO
- Differences resolved - YES
- Differences resolved - NO
- Capability reviewed - YES
- Capability reviewed - NO
- Records of reviews maintained - YES
- Records of reviews maintained - NO
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Requirements - Customer Communication
- Product information provided - YES
- Product information provided - NO
- Communication plan - YES
- Communication plan - NO
- Customer feedback mechanism in place - YES
- Customer feedback mechanism in place - NO
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
7.3 Design and Development
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Area audited and evidence
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Requirements - Design Planning
- Planned Stages - YES
- Planned Stages - NO
- Review processes appropriate for each stage - YES
- Review processes appropriate for each stage - NO
- Responsibilities assigned - YES
- Responsibilities assigned - NO
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Requirements - Design Inputs
- Function and performance requirements - YES
- Function and performance requirements - NO
- Statutory and regulatory requirements - YES
- Statutory and regulatory requirements -NO
- Similar designs - YES
- Similar designs - NO
- Other inputs - YES
- Other inputs - NO
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Requirements - Design Outputs
- Meet the inputs - YES
- Meet the inputs - YES
- Provide appropriate information - YES
- Provide appropriate information - NO
- Provide acceptance criteria - YES
- Provide acceptance criteria - NO
- Specify essential characteristics - YES
- Specify essential characteristics - NO
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Requirements - Design Review
- Meets inputs - YES
- Meets inputs - NO
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Requirements - Design Verification
- Technical compliance with inputs - YES
- Technical compliance with inputs - NO
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Requirements - Design Validation (prototype etc.)
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Requirements - Design change management
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
7.4 Purchasing
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Area audited and evidence
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Requirements - Process
- Supplier Management - YES
- Supplier Management - NO
- Supplier Evaluation - YES
- Supplier Evaluation - NO
- Records of evaluation - YES
- Records of evaluation - NO
- Purchasing specification - YES
- Purchasing specification - NO
- Requirements for supplier personnel - YES
- Requirements for supplier personnel - NO
- Quality System Requirements - YES
- Quality System Requirements - NO
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
7.5 Production & Service Provision
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
7.6 Monitoring and Measurement Equipment
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
8.1 Measurement Analysis & Improvement
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
8.2.1 Customer Satisfaction
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
8.2.2 INTERNAL AUDIT
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
8.2.3 MONITORING AND MEASUREMENT OF PROCESSES
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
8.2.4 MONITORING & MEASUREMENT OF PRODUCT
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
8.3 CONTROL OF NON-CONFORMING PRODUCT
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
8.4 ANALYSIS OF DATA
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
8.5.1 CONTINUAL IMPROVEMENT
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
8.5.2 CORRECTIVE ACTION
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
8.5.3 PREVENTIVE ACTION
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
OPERATIONAL AREAS
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
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Do you have procedures that define what you do?
OPERATIONAL AREAS
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
OPERATIONAL AREAS
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
OPERATIONAL AREAS
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Area audited and evidence
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Requirements
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Conclusion
- Satisfactory
- Major Non-conformity
- Minor Non-conformity
- Observation
- Improvement Opportunity
- Not Applicable
- Not Verified
- More evidence required
