ISO 9001:2015 Internal Auditing for the Context of the Organization

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Process Management ConceptIdeas for ISO 9001:2015 Internal Auditing

As ISO 9001 organizations adjust their systems to meet 2015 requirements, it opens an opportunity to add two new processes to the internal auditing requirements to capture effective implementation.

Audit program managers might want to consider Context of the Organization and Strategic Direction as separate audits inside of the organization’s audit program.  Adding these topics to the internal audit process based format requires inputs/outputs to these processes as well as measurement activities to demonstrate effective implementation.

Internal auditors should begin with top management.  Auditors should be looking for available documented information that determines what the Strategic Direction is.   This would cover many of the segments of the Context of the Organization that have been established.  Some of the segments include internal and external issues, and the organization’s interested parties.

Once auditors have gathered this information, the next step is verifying top management’s commitment. Example is a commitment to supporting the strategic direction and the assignment of personnel leading the planned direction.  Another example is top management’s development of Quality Objectives addressing the planned direction and tracking of progress.   Once the direction and context process has been established, progress will appear in retained documented information (records) and available for auditor review.

Internal auditors might consider the following questions for management that address Strategic Direction:
1) Tell me about your company’s strategic direction?
2) Who are the senior managers leading this effort?
3) What activity is ongoing and how is progress reviewed?
4) Let’s review the management review records? Is the QMS aligned with the Strategic Direction?

These questions would provide adequate information about Strategic Direction implementation and probably Context of the Organization.

Risk planning and auditing will be addressed in a subsequent article.

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