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ISO 9001:2015 Requirement 4.1: Understanding the Organization's Context

ISO 9001:2015 Requirement 4.1: Understanding the Organization’s Context

Understand the importance of analyzing the Organization's Context in ISO 9001:2015 and what aspects to consider in this analysis.

The requirement “4.1 Understanding the organization and its context” is one of the initial requirements of ISO 9001:2015. We can say that it acts as an “opening” for all the subsequent work on implementing the Quality Management System (QMS).

From the analysis that it proposes, the necessary definitions and actions within the QMS begin to truly take shape. After all, implementing a management system without understanding the context in which it is embedded is likely to create unnecessary bureaucracy. And, even worse, it will not achieve one of the main objectives: helping the organization to optimize the performance of its processes.

In today’s article, I will talk a little about this item and its importance for organizations. Before we start our reflections, let’s look at the wording of the requirement in the standard.

“4.1 Understanding the organization and its context

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended outcome(s) of its quality management system.

The organization shall monitor and review information about these external and internal issues.

NOTE 1 Issues can include positive and negative factors or conditions for consideration.

NOTE 2 Understanding of the external context can be facilitated by considering issues arising from the legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local.

NOTE 3 Understanding of the internal context can be facilitated by considering issues related to values, culture, knowledge, and performance of the organization.”

Determining External and Internal Issues

If we think about it, the context of the organization is not something new, nor is it something that ISO 9001 invented. Tools such as SWOT or PESTEL analysis have been used for a long time and are intended to help understand how organizations relate to their environment.

ISO 9001:2015 merely formalized the need to take these factors into account when they can affect the quality of products or services in some way. Therefore, when the standard talks about “determining,” we need to interpret this as “analyzing.”

This means we need to identify everything that involves our company and interferes with its operations in some way, whether to benefit or harm it. When external, these factors can be local, such as the challenging logistics of a company in a rural area, or global (the COVID-19 Pandemic is an example of this).

Internally, we could mention positive aspects that help improve deliveries, such as the high level of employee training. We can also talk about negative points, such as the need to modernize machinery and equipment.

Obviously, the factors I am mentioning are just examples. They are merely types of factors that can affect (positively or negatively) a company. To meet this item, you need to analyze your company and the set of elements it is involved with. Only then can you truly understand the context of your organization.


What should I analyze to determine the organization’s context?

It’s impossible for me to provide an exact list of everything that can be analyzed. This is because each company is unique and, therefore, has a unique context. There are thousands (perhaps millions) of elements interacting with it daily, so all of them can, in some way, affect its capacity.

However, the standard itself provides some examples and items that can be analyzed.

External Factors

In “NOTE 2,” for example, the technological factor is exemplified, as I mentioned earlier. We also have cultural factors because the culture of a society is a determining factor in understanding its demands. For instance, while pork is widely consumed in Brazil, working with pork derivatives can be difficult (or even unfeasible) in countries of Muslim or Jewish origin.

Legal aspects, such as laws, regulations, and even taxes, can also drastically affect the operation of a company and may even require changes in processes. An example we are experiencing is the emergence of the LGPD (General Data Protection Law), a law that needs to be complied with throughout the national territory.

Internal Factors

In the internal analysis, NOTE 3 mentions factors such as the company’s internal culture (habits, customs, and “ways of doing” that are characteristic of it). It mentions the knowledge it has acquired over its experience and the values that permeate the organization.

An interesting point is that ISO 9001:2015 states that the performance of the organization is a factor that can help understand the context. It’s not very intuitive to think, for example, that how much we can deliver is part of the context.

However, if we analyze, understanding the performance of our processes and the people who work with us can help determine, for example, how to penetrate a certain market or how to maximize profits. And this, definitely, needs to be constantly analyzed.


The Context of the Organization is Organic and Constantly Changing

About 2 years ago, no one needed to wear a mask, and the thought of a global pandemic seemed like something out of a movie. However, today, this is a reality that has affected the context of billions of companies and introduced a new factor: the near-mandatory requirement for Covid prevention measures.

Therefore, ISO mandates that “The organization shall monitor and review” the context critically. This means that our definition of the context must be updated as it (the context) actually changes. Thus, from time to time, it’s necessary to revisit and update our analyses.

To conclude, I would like to emphasize that even if a company is not certified, defining the context is essential. Therefore, we need to understand this requirement not as “just another item in the standard,” but as something fundamental for our growth and for delivering the best in our processes.

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QMS Certification

QMS is an accredited third party certification body, it is currently present in 33 countries and focuses on the certification of management systems. QMS America is managed by the US office and has consistently grown in market recognition by technical level, customer satisfaction and competitive pricing.

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