Before conducting the document review of the management system, should the internal Audit Plan be created?

Creating an internal audit plan is not a prerequisite for conducting a document review of the management system. The document review can be carried out independently to ensure that the necessary documentation is in place, complete, and adheres to the requirements stated in the ISO 9001 standard. Document reviews generally focus on validating the contents of quality manuals, procedures, work instructions, and records to ensure they effectively support the implementation of the Quality Management System (QMS).

The internal audit plan is typically developed after the document review because it outlines the approach for auditing the QMS's processes, addressing specific areas of risk, and ensuring compliance with the ISO requirements. This means that while both elements are crucial for maintaining an effective QMS, the timing of their execution does not necessitate that one precedes the other.

In summary, document reviews serve as a fundamental step to ensure that documentation aligns with ISO 9001 requirements, while the internal audit plan is developed later as part of a systematic approach to assess the effectiveness of the QMS.