The Context of the Organization according to the ISO 9001:2015 Standard
Understanding the context of an organization is now standard requirement. It is not a new concept but it is officially adopted by the ISO 9001:2015 Standard, and when developing a quality management system (QMS), it is required to identify, analyze, and understand the business environment in which the organization conducts its business and realizes its product.
Any organization is a combination of different business entities (functions or systems— internal or external) that relate and interact with each other and exchange information and materials. The context of the organization is an outline of the interaction and integration of these business entities. It is the set of functions, factors, processes, inputs and outputs, and conditions and limitations that create the business environment of an organization—these encompass both internal and external issues. These issues have an impact on the ability of the organization to provide the product and thus affect the goals and objectives of the organization. Thus the deduction: when determining your business strategy and setting the objectives of your QMS, you should understand, consider, and refer to these aspects. Understanding the context of the organization is key to a correct business strategy, let alone a correct quality strategy.
The Principle of the Context of the Organization
The ISO 9001 Standard recognizes the importance and role of the context of the organization and requires its definition when establishing a QMS. The analysis regarding the context of the organization is a natural process that each organization must follow at some point in its life. The ISO 9001:2015 aspires to institutionalize the context as the foundation for the QMS. Organizations usually have several strategies or concepts in various fields and areas that dictate the direction of the organization: financial strategy, sales and marketing strategy, purchase strategy, IT concept, and so on. One clear objective of determining the context of the organization is to harmonize these various strategies and concepts. By determining the context of the organization, the organization identifies the scope and boundaries of its activities that will be reflected in the QMS. From the context of the organization we derive the goals and objectives of the QMS. After attending to these points, you should have a clear picture of the business environment in which your organization is active and you would be in the right position to plan and define your QMS, its goals, and objectives.
Go on and read about the next ISO 9001:2015 requirement – leadership and commitment.
This webpage contains only a fragment of the chapter 4 Context of the Organization from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:
Why choose the book ISO 9001:2015?
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