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
Previous Section 9 Audit
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Has the previous audit been reviewed?
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Why hasn't the previous audit been reviewed?
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Have all previous NCR's been actioned and appropriately closed?
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Raise the Same NCR number to the required sections!
Section 9.1 - Monitoring & Measuring - 9.1.1 - General
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Has the organisation determined what needs to be monitored and measured?
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Has the organisation determined the methods for monitoring, measurement, analysis and performance evaluation, as applicable, to ensure valid results?
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Has the organisation determined when the monitoring and measuring shall be performed?
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Has the organisation determined when the results from monitoring and measurement shall be analysed, evaluated and communicated?
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Has the organisation ensured that monitoring and measuring equipment is calibrated or verified as applicable, and is used and maintained as appropriate?
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Has the organisation retained appropriate documented information as evidence of the results of monitoring, measurement, analysis and performance evaluation?
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Has the organisation retained appropriate documented information on the maintenance, calibration or verification of measuring equipment?
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Section 9.1 - Monitoring & Measuring - 9.1.2 - Customer Satisfaction
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Does he organisation monitor the customers perceptions of the degree to which their needs and expectations have been fulfilled. The organisation shall determine the methods for obtaining, monitoring and reviewing this information?
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Section 9.1 - Monitoring & Measuring - 9.1.3 - Analysis & Evaluation
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Has the organisation analysed and evaluated the appropriate data and information arising from monitoring and measurement including results of conformity of products and services?
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Has the organisation analysed and evaluated the appropriate data and information arising from monitoring and measurement including results of the degree of customer satisfaction?
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Has the organisation analysed and evaluated the appropriate data and information arising from monitoring and measurement including results of the performance and effectiveness of the QMS?
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Has the organisation analysed and evaluated the appropriate data and information arising from monitoring and measurement including results if planning has been implemented effectively?
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Has the organisation analysed and evaluated the appropriate data and information arising from monitoring and measurement including results of the effectiveness of actions taken to address risks and opportunities?
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Has the organisation analysed and evaluated the appropriate data and information arising from monitoring and measurement including results of the performance of external providers?
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Has the organisation analysed and evaluated the appropriate data and information arising from monitoring and measurement including results of the need for improvements to the QMS?
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Section 9.2 - Internal Audit
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Has the organisation conducted internal audits at planned intervals to provide information on whether the QMS conforms to the organisation’s own requirements for its quality management system, including the quality policy and quality objectives?
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Has the organisation conducted internal audits at planned intervals to provide information on whether the QMS conforms to the requirements of ISO 9001?
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Has the organisation conducted internal audits at planned intervals to provide information on whether the QMS is effectively implemented and maintained?
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Has the organisation planned, established, implemented and maintained an audit programme(s) including the frequency, methods, responsibilities, consultation, planning requirements and reporting, taking into consideration the importance of the processes concerned, and the results of previous audits?
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Has the organisation defined the audit criteria and scope for each audit?
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Has the organisation selected auditors and conducted audits to ensure objectivity and the impartiality of the audit process?
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Has the organisation ensured that the results of the audits are reported to relevant managers?
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Has the organisation taken action to address nonconformities and continually improve its quality performance (see Clause 10)?
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Has the organisation retained documented information as evidence of the implementation of the audit programme and the audit results?
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Section 9.3 - Management Review
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Does top management review the organisation's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness?
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Does the management review include consideration of the status of actions from previous management reviews?
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Does the management review include consideration of changes in external and internal issues that are relevant to the QMS?
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Does the management review include information on the quality performance, including trends in customer satisfaction and feedback from relevant interested parties?
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Does the management review include information on the quality performance, including trends in the extent of which quality objectives have been met?
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Does the management review include information on the quality performance, including trends in process performance and conformity of products and services?
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Does the management review include information on the quality performance, including trends in NCR's and corrective actions?
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Does the management review include information on the quality performance, including trends in monitoring and measurement results?
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Does the management review include information on the quality performance, including trends in audit results?
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Does the management review include information on the quality performance, including trends in the performance of external providers?
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Does the management review include information on the quality performance, including trends in adequacy of resources?
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Does the management review include information on the quality performance, including trends in the effectiveness of actions taken to address risk and opportunities?
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Does the management review include information on the quality performance, including trends in opportunities for continual improvement?
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Do the outputs of the management review include decisions related to continual improvement opportunities?
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Do the outputs of the management review include decisions related to any need for changes to the quality management system?
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Do the outputs of the management review include decisions related to resources needed?
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Does the organisation retain documented information as evidence of the results of management reviews?
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