Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to assess both internal and external issues that could impact the effectiveness of their Quality Management System (QMS).
Clause Reference:
Clause 4.1 – Understanding the Organization and Its Context states that organizations must determine external and internal issues that affect their ability to achieve intended results.
Internal issues include:
Knowledge within the organization (documented or undocumented)
Organizational culture
Resource availability
Technological advancements
Infrastructure and capabilities
Why is the Correct Answer C?
Knowledge (Clause 7.1.6) is a critical internal factor that directly affects the implementation and maintenance of a QMS.
Organizations must identify, maintain, and make available the necessary knowledge to achieve quality objectives and meet customer requirements.
Why are the Other Options Incorrect?
A (Social and economic environments) → These are considered external issues rather than internal.
B (Competitive environment) → Competition is external, not an internal issue affecting the QMS.
D (Expectations of suppliers) → Supplier expectations relate to external interested parties, covered under Clause 4.2 (Understanding the Needs and Expectations of Interested Parties).
[Reference:, ISO 9001:2015, Clause 4.1 – Understanding the Organization and Its Context, ISO 9001:2015, Clause 7.1.6 – Organizational Knowledge, , ]
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