• Does the organization use external providers to accomplish any part of it's final product?

  • Are the persons necessary for the effective implementation of the quality system provided?

  • Are the facilities appropriate for the organization?

  • Is equipment available and in sufficient quantities to assist the employees in accomplishing their work?

  • Are sufficient computer terminals and office equipment in place?

  • Does IT enhance the operation?

  • Is the social, psychological, and physical environment suitable for the organization to accomplish it's mission?

  • Does the organization periodically determine it's needs for support?

  • Does the organization need to perform measurements of it's product or use measurements in it's processes?

  • Is there a calibration program in place for the organization?

  • Is there a recall program for failed calibrated tooling?

  • Does the organization determine it's Organizational Knowledge requirements and does it develop it and work to keep it?

  • Is organizational knowledge documented and shared in training or through shadowing?

  • Is employee competence ensured?

  • Does the organization take action to acquire the necessary competence and evaluate the effectiveness of those actions?

  • Are the actions taken documented?

  • Are the organization employees aware of the quality policy?

  • The quality Objectives?

  • Their contribution to the effectiveness of the quality management system?

  • The implications of not conforming with the quality management system requirements?

  • Their contribution to product conformity?

  • Their contribution to product safety?

  • And, the importance of ethical behavior?

  • Has the company determined it's relevant external and internal communications?

  • Does the organization's documented information comply with the requirements in 7.5?

  • Is the Documented information identified and controlled appropriately according to section 7.5.2 and 7.5.3?

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