ABSTRACT
The chapters for management responsibility (Chapter 3) and corrective action/ preventive action (CAPA) (Chapter 4) discuss the three-legged stool (Chapter 1). The internal audit process is the third leg of that stool. An effective program is critical to the overall effectiveness of the system. Each leg of the stool must be strong and effective. Third-party auditors are trained to evaluate based on evidence conrming that the internal audit program is suitable and effective for the management system. If the auditors are not, then the system’s overall compliance status may be affected.
