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Quality management system
Is there a Quality Manual (electronic or hard copy) that is maintained in a controlled manner?
Are documents and data reviewed and approved by authorized personnel, prior to issue?
Is there a master list of documents that are controlled and updated as needed?
Are all pertinent documents available to operators where the function is being performed?

Management responsibility
Is the Quality Policy implemented, and have measurable Quality Objectives?
Has the responsibility, authority, interrelationship of personnel who manage, perform and verify work affecting quality issues been identified and documented?
Are there documented methods to track, update, revise and review the business plan to ensure it is communicated and followed throughout the organization, as appropriate?
Are trends in data and information compared with competitors, benchmarks and objectives?
Is there a documented process to measure customer satisfaction?
Is the question "Is the QMS system effective?" asked... and the answer reacted upon if needed?
Are the above items discussed/documented/addressed (annually, at a minimum) at a Management Review?