Understanding "Context of the Organization":
The term "context of the organization" is defined in ISO 9001:2015 Clause 4.1, which states:
"The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system."
The definition emphasizes identifying both internal and external issues that influence the organization's approach to developing and achieving its objectives.
Option Analysis:
Option A:Correct. This option aligns with the standard definition as it explicitly mentions the combination of internal and external issues that affect the organization’s approach to achieving its objectives, which is the essence of Clause 4.1.
Option B:Incorrect. The term "comparison of internal and external issues" does not reflect the ISO 9001 requirements. The standard does not require a comparison but rather an understanding of these issues.
Option C:Incorrect. Although it mentions "complexity," the focus of ISO 9001:2015 is on identifying relevant issues rather than the complexity of those issues.
Option D:Incorrect. This option mentions "coordination" and focuses only on the positive or negative effects. ISO 9001 requires identifying issues but does not emphasize coordination.
Clause Reference and Relevance:
ISO 9001:2015 requires organizations to understand their context because internal and external factors can influence the Quality Management System's effectiveness. Understanding this context helps in:
Addressing risks and opportunities (Clause 6.1).
Aligning the QMS with the organization’s strategic direction.
Why A is Correct:
"Combination of internal and external issues" captures the essence of Clause 4.1, making it the accurate definition of the context of the organization.