• Does the organization plan and implement the monitoring, measurement, analysis, and improvement processes needed to demonstrate conformity to the product?
• As one of the measurements of the performance of the quality management system, does the organization monitor information relating to customer perception as to whether the organization has met customer requirements?
• Does the organization conduct internal audits at planned intervals?
• Are the audit criteria, scope, frequency, and methods defined?
• Does the organization ensure internal auditors do not audit their own work?
• When planned results are not achieved, is correction and corrective action taken, as appropriate, to ensure conformity of the product or service?
• In the event of process nonconformity, does the organization take appropriate action to correct the nonconforming process? Evaluate whether the process nonconformity has resulted in product nonconformity? Identify and control the nonconforming product?
• Does the organization monitor and measure the characteristics of the product to verify that product requirements have been met?
• When key characteristics have been identified, are they monitored and controlled?
• When the organization uses sampling inspection as a means of product acceptance, is the plan statistically valid and appropriate for use?
• Is product held until it has been inspected or otherwise verified as conforming to specified requirements, except when product is released under positive recall procedures pending completion of all required measurement and monitoring activities?
• Do records indicate the person(s) authorizing release of product?