CHAPTER 3: THE INTERNAL AUDIT PROCESS

The requirements for internal management systems audits specified in a number of ISO standards are based heavily on those originally contained in ISO9001. A review of standards as diverse as ISO13485 for medical device manufacturers Quality Management System, and ISO/IEC 17025 for testing/calibration laboratories, to ISO22301 for Business Continuity Management, shows that the requirements for internal audits are substantially similar to the basics in ISO9001, 8.2.2.

Internal audits may be effectively managed as a process according to Dr. Shewhart’s “Plan, Do, Check, Act” cycle. A diagram of the process might look like this:

Audit Programs

In the early period of the implementation of a management system, ...

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