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Auditing Tip of the Month
October 1997

Audit Procedures

An audit procedure should include the following:

  1. An objective 
  2. Audit scope 
  3. An audit schedule 
  4. Assignment of responsibilities 
  5. Evaluation criteria 
  6. Management review of results 
  7. Corrective action policies, schedules, etc. 

Source: Medical Device Quality Systems Manual: A Small Entity Compliance Guide

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