Title Page
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Site conducted
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Prepared by
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Location
General
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1. Has the organization determined and selected opportunities for improvement and implemented the necessary actions in order to: • Meet customer requirements and enhance customer satisfaction • Correcting, preventing or reducing undesired effects • Improving the performance and effectiveness of the QMS
Nonconformity and corrective action
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1. When nonconformities occur, show me how: • You react • Take action to control and correct it • Deal with the consequences • Evaluate the need for action to eliminate the cause so that it does not recur or occur elsewhere by reviewing and determining the cause of the non-conformity. • Determining if similar nonconformities exist or could potentially occur • Actions needed are implemented • Review the effectiveness of corrective actions taken if any • Make necessary changes to the QMS
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2. Show me how corrective actions were appropriate to the effects of the nonconformities encountered.
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3. What documented information can you show me as evidence of the nature of the non-conformities and subsequent actions taken. Can you show me the results of any corrective action taken?
Continual improvement
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1. Demonstrate that you continually improve the suitability, adequacy, and effectiveness of the QMS.
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2. Is the organization using the outputs from analysis, evaluation and management review activities to identify improvement opportunities and quality management system underperformance and that appropriate actions have been taken to address any shortcomings ?
