When the latest version of the international standard for quality management systems, ISO 9001, was released in 2015, it was noted that it included among the requirements for companies to consider external factors. This request at the time caused some confusion, especially for companies that were updating the Quality Management System from ISO 9001:2008 to ISO 9001:2015.
These new requirements are mainly grouped in Chapter 4 which concerns, in fact, the context of the organization and which contains the basis for your activity.
Why do we need to understand the context of the organization and what exactly does it mean? In simple terms, it means that we must be aware of what is happening outside of our business and that we must understand that the external environment shapes our business behavior.
If we are not aware of external factors and how they can affect our business, we are unable to understand what needs to be done to protect the organization from the outside world. There are numerous situations that can actually happen and we need to be aware of the related factors and understand their potential consequences. Only then can we determine if we can do prevention in these situations and how.
Once this first step has been taken, we must also strive to understand the needs and expectations of stakeholders. We all know that the main goal of any company is its customers. However, in addition to our customers, we also need to interact with many other people, such as suppliers, our employees, the various entities and many others. Let us ask you: do you know what your customers want from you and what are the reasons that lead them to interact with you? And if the person you are about to meet becomes your most important future customer or partner?
How important is this relationship to you and what do you need to know to make it work best? What would happen if the relationship with a customer or a significant supplier broke down and cost you a great deal or, worse still, resulted in failure? We hope that, at this point, it is clear how important it is to understand who the people you interact with are and what they expect from you. Precisely for this reason, the standard requires that organizations be aware of the different types of stakeholders, whether internal (e.g. employees) or external (e.g. suppliers, entities, etc.) and understand that the relationship could represent a risk to the business or could create an opportunity. Therefore, it is necessary to understand how to manage these relationships.
The third requirement concerns the determination of the scope of the Quality Management System. It is at this point that the greatest doubts arise because it is difficult to define the scope of something intangible and abstract like a management system. The requirement, in reality, requires thinking about external and internal factors, the interested parties and the scope of your business to ensure that all these aspects have been taken into consideration. It is the scope of your management system that draws the boundaries and clearly indicates what falls within the scope of the management system and what does not. If you decide to create a new service or start a new business, you will have to consider them as an expansion of the scope, as you will have to deal with new procedures, different stakeholders and other factors.
Regarding the fourth requirement, the identification and measurement of the processes of the Quality Management System, it is important not to forget to make sure that you have understood the reciprocal interactions between the different processes and the sequences. Why is it important? In a small organization where everyone knows everything, the flow of information is direct. However, when the organization grows and the number of people increases, the complexity of the company and its structure expands and that is why everything must be clear and monitored.