Title Page
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Conducted on
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Prepared by
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Location
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Does the organization use external providers to accomplish any part of it's final product?
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Are the persons necessary for the effective implementation of the quality system provided?
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Are the facilities appropriate for the organization?
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Is equipment available and in sufficient quantities to assist the employees in accomplishing their work?
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Are sufficient computer terminals and office equipment in place?
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Does IT enhance the operation?
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Is the social, psychological, and physical environment suitable for the organization to accomplish it's mission?
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Does the organization periodically determine it's needs for support?
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Does the organization need to perform measurements of it's product or use measurements in it's processes?
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Is there a calibration program in place for the organization?
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Is there a recall program for failed calibrated tooling?
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Does the organization determine it's Organizational Knowledge requirements and does it develop it and work to keep it?
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Is organizational knowledge documented and shared in training or through shadowing?
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Is employee competence ensured?
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Does the organization take action to acquire the necessary competence and evaluate the effectiveness of those actions?
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Are the actions taken documented?
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Are the organization employees aware of the quality policy?
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The quality Objectives?
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Their contribution to the effectiveness of the quality management system?
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The implications of not conforming with the quality management system requirements?
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Their contribution to product conformity?
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Their contribution to product safety?
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And, the importance of ethical behavior?
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Has the company determined it's relevant external and internal communications?
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Does the organization's documented information comply with the requirements in 7.5?
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Is the Documented information identified and controlled appropriately according to section 7.5.2 and 7.5.3?
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