This means that you need to define influences of various elements on the organization and how they reflect on the QMS, the company’s culture, objectives and goals, complexity of products, flow of processes and information, size of the organization, markets, customers, etc. It pretty much changes the concept and application of clause 4, and requirements regarding the context of the organization do sound a little bit vague, so what does this clause actually require?Ĭlause 4 of ISO 9001:2015 Context of the organization requires the organization to evaluate itself and its context. Context of the organization is a new requirement in ISO 9001, stating an organization must consider both the internal and external issues that can impact its strategic objectives and the planning of the QMS.
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