ISO 9001 Context of the Organization

ISO 9001:2015 is a standard that outlines the requirements for a quality management system (QMS) in an organization. One of the key changes introduced in the 2015 version of the standard is the concept of "context of the organization."

The context of the organization refers to the internal and external factors that can affect the organization's ability to achieve its objectives. These factors include the organization's culture, values, and goals, as well as the needs and expectations of interested parties such as customers, suppliers, employees, and regulatory bodies.

ISO 9001 requires organizations to determine and understand their context, including the relevant internal and external issues and the interested parties requirements. This understanding helps the organization to identify risks and opportunities and determine the scope of the QMS.

The organization's context also influences the design, implementation, and improvement of the QMS. By considering the context, the organization can ensure that its QMS is tailored to its specific needs and goals and is aligned with its overall strategic direction.

Overall, the context of the organization is a crucial element of ISO 9001 as it helps organizations to develop a QMS that is effective and relevant to their unique circumstances.

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