According to ISO 9001:2015, clause 4.3, the organization is required to determine the scope of its quality management system (QMS) by considering the external and internal issues referred to in clause 4.1. Clause 4.1 requires the organization to determine the external and internal issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended results of its QMS. These issues can include positive and negative factors or conditions for consideration, such as legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local. The organization is also required to monitor and review these issues.
Therefore, the correct answer is C, as external issues of the organization’s context are one of the factors that must be considered when determining the scope of the QMS. The other options are either not directly related to the scope of the QMS, or are not explicitly mentioned in clause 4.3.
[References:, ISO 9001:2015(en), Quality management systems — Requirements, clause 4.1 and 4.3, ISO 9001:2015 – How to determine the scope of your QMS - Advisera, section “Considerations for determining the scope of the QMS in ISO 9001”, ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section “Learning objectives”, ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 4, , , ]
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