The requirements contained in the fourth chapter of ISO 9001:2015, "Context of the organization," were included by Technical Committee 176, which handled the standard's update, to provide a connection between the activity of leading an organization and implementing a quality system.
Historically, quality and business management have always been perceived as two different systems, with quality seen as something additional to normal business operations. The inclusion of this chapter on context, not only in ISO 9001 but also – for example – in ISO 14001 and ISO 27001, is linked to the ISO's strong desire to express the need for organizations to begin focusing on their future in a structured manner.
A kind of strategic planning. For the first time, with ISO 9001:2015, there is an attempt by the Technical Committee to align an organization's quality system with the operation of its business so that the objectives, processes, controls, measurements, and all actions taken assist each company's way of doing business.
To analyze the internal and external factors that may in some way influence the company's quality system, a procedure is not necessary: it is enough to use two tools that those involved in corporate strategy usually know very well: SWOT analysis and PEST analysis. The first will apply to internal factors and examine the strengths, weaknesses, opportunities, and risks associated with individual factors, while the second will be based on political, economic, social, and technological reflections of the external environment. These two tools will serve to give a general overview of the environment in which an organization operates.
ISO 9001:2015 does not explicitly define what to do with the information collected at this level because this will depend on company management, but it explains that it will enter as input into the management review and that it will also constitute input for the planning phase of the quality system. Practically, the quality policy will arise from the context analysis, and from this, the objectives that must:
- be measurable
- take into account applicable requirements
- be relevant to the conformity of products and services and customer satisfaction
- be monitored
- be communicated
- be updated whenever necessary
Obviously, once the context has been analyzed, the analysis must be kept up to date because any changes in the internal or external environment in which the organization operates could affect the quality system. Company management must always ensure that it can identify those few critical factors that are fundamental to creating a strategy and action plan.
The results of the context analysis, together with the needs and expectations of interested parties, will define the actions to manage risks and opportunities, which is a requirement we find in the sixth chapter of the standard. A plan must be prepared that includes these actions in the processes of the company's quality system.
The last part of chapter four of the standard has to do with the request to determine the scope of the quality system. Each organization has a certain freedom in selecting the activities, products, and services to be included within the boundaries of the quality system, but with one exception: if the purpose of building a quality system is to have it certified by a third-party body, then no requirement of the standard can be considered not applicable if it reflects on the organization's ability or responsibility to ensure the conformity of products or services and customer satisfaction.
Be careful that the scope of the quality system is kept as "documented information" that will contain information relating to the products and services that an organization offers on the market and any justifications for why some ISO 9001 requirements are not applicable.