Title Page
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Site conducted
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Conducted on
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Prepared by
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Location
Untitled Page
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7.0 Support
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7.1 Resources
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7.1.1 General
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How does the organization determine and provide the necessary resources for the QMS?
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Can you share examples of how the organization ensures that resources are available, maintained, and monitored for effectiveness?
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7.1.2 People
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How does the organization ensure that it has the required personnel to effectively implement the QMS and maintain its processes?
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Can you provide examples of how the organization manages personnel resources to meet its quality objectives?
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7.1.3 Infrastructure
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How does the organization identify and provide the necessary infrastructure for the QMS?
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Can you provide examples of how the organization maintains and improves its infrastructure to support its processes and achieve its quality objectives?
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7.1.4 Environment for the Operation of Processes
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How does the organization determine and manage the work environment needed for its processes?
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Can you share examples of how the organization ensures that the work environment supports the achievement of its quality objectives?
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7.1.5 Monitoring and Measuring Resources
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How does the organization identify and provide the necessary monitoring and measuring resources to ensure valid results?
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Can you provide examples of how the organization ensures that monitoring and measuring resources are calibrated and maintained?
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7.1.6 Organizational Knowledge
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How does the organization identify, maintain, and manage the necessary organizational knowledge for its processes?
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Can you share examples of how the organization acquires and shares new knowledge within the organization?
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7.2 Competence
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How does the organization determine the necessary competence for personnel affecting the QMS performance?
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Can you explain how the organization ensures that personnel are competent and, if necessary, provide training or other actions to acquire the required competence?
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How does the organization evaluate the effectiveness of the actions taken to address competence requirements?
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7.3 Awareness
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How does the organization ensure that personnel are aware of the quality policy, quality objectives, and their contribution to the QMS?
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Can you provide examples of how the organization promotes awareness of the importance of conforming to QMS requirements and enhancing customer satisfaction?
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7.4 Communication
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How does the organization determine and implement internal and external communication relevant to the QMS?
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Can you explain how the organization ensures the effectiveness of its communication processes?
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7.5 Documented Information
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7.5.1 General
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How does the organization create, update, and control documented information required by the QMS?
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Can you provide examples of how the organization ensures the availability and suitability of documented information?
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7.5.2 Creating and Updating
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How does the organization ensure that documented information is properly identified, described, reviewed, and approved before use?
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Can you provide examples of recent updates to documented information and the process followed?
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7.5.3 Control of Documented Information
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Can you explain how the organization controls access, distribution, and retrieval of documented information?
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How does the organization ensure the proper storage, preservation, and disposal of documented information?
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9.0 Performance Evaluation
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9.1 Monitoring, Measurement, Analysis, and Evaluation
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9.1.1 General
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How does the organization determine what needs to be monitored and measured and the methods, criteria, and timing for monitoring and measurement?
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Can you provide examples of the organization's approach to maintaining documented information as evidence of the results?
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9.1.2 Customer Satisfaction
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How does the organization monitor and measure customer satisfaction?
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Can you provide examples of methods used to obtain and analyze customer feedback?
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9.1.3 Analysis and Evaluation
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How does the organization analyze and evaluate the data and information from its monitoring and measurement activities?
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Can you provide examples of how the organization uses the analysis results to improve its QMS?
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9.2 Internal Audit
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Can you explain the organization's internal audit process, including planning, conducting, reporting, and follow-up activities?
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How does the organization ensure that internal audits are objective and impartial?
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9.3 Management Review
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How does the organization conduct management reviews to ensure the continuing suitability, adequacy, and effectiveness of the QMS?
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Can you provide examples of inputs, outputs, and actions taken as a result of management reviews?
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10.0 Improvement
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10.1 General
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How does the organization identify and implement opportunities for improvement in its QMS?
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Can you provide examples of recent improvements and the processes used to identify and implement them?
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10.2 Nonconformity and Corrective Action
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How does the organization handle nonconformities and take corrective actions to prevent recurrence?
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Can you provide examples of recent nonconformities, the performed, and the corrective actions taken?
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10.3 Continual Improvement
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How does the organization continually improve the suitability, adequacy, and effectiveness of its QMS?
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Can you provide examples of how the organization uses data and information from monitoring, measurement, analysis, and evaluation to drive continual improvement?
