ISO 9001 - Sub_clause 4.1 – Understanding the organization and its context (Part 2)


In previous posts I have analysed the context of ISO 9001: 2015 standard, from the information with which the International Organization for Standardization (ISO) presents both the management system standards, such as this particular standard, on its website, through the introductory elements, such as the Foreword of the standard itself and its clauses Introduction, 1. Scope, 2. Normative references, 3. Terms and definitions, and ending with complementary elements, such as Bibliography and informative Annexes.


I also presented to you a post in which I began the analysis of the text of this standard, that is, those elements that make up its technical body, and which are those that comprise clauses 4 to 10, considering that this ISO 9001: 2015 standard, as well as each of the requirements established in it, should generate value for the organization that correctly implements them within its quality management system.


To carry out this analysis, we must remember something that I have already mentioned and that is included in the Introduction Clause which, although it does not establish any specific requirement, provides us with a large amount of information, which we should always take into account, among which stands out that in this standard the following verb forms are used:

In the same way, it clarifies that the information identified as "NOTE" is presented as an orientation for the understanding or qualification of the corresponding requirement.


Let us, therefore, begin to analyse the content of Clause 4: Context of the organization, of ISO 9001: 2015 standard, and for this it is important to know the definition of this term that is established in ISO 9000: 2015 standard.



This clause does not specifically establish any requirement, but displays four subclauses, which do contain requirements, and which are the following:

If you are determined in establishing, implementing, verifying, auditing, maintaining and improving a quality management system in compliance with ISO 9001: 2015 standard, I recommend that you do not fail to meet completly each of the requirements of the standard, and that each time you read and discuss one of these requirements, consider it within the context of the organization, its structure, its processes, and its documented support.


After this introduction, this time I will continue with the analysis of Sub-Clause 4.1. Understanding of the organization and its context, which establishes, in its first paragraph, the following requirements:


Requirement No. 1: The organization shall determine external issues that are relevant to its purpose, and that affect its ability to achieve the intended results of its quality management system.


Requirement No. 2: The organization shall determine the external issues that are relevant to its strategic direction, and that affect its ability to achieve the intended results of its quality management system.


Requirement No. 3: The organization shall determine the internal issues that are relevant to its purpose, and that affect its ability to achieve the intended results of its quality management system.


Requirement No. 4: The organization shall determine the internal issues that are relevant to its strategic direction, and that affect its ability to achieve the intended results of its quality management system.


These are the first four requirements of ISO 9001: 2015. If you read them hastily, or carelessly, you might think they are repeating the same requirement, but they are not. Although they are very similar, each of these requirements contains different elements, and they should be analysed in detail.


But before that, let me mention that in this subclause 4.1, the standard includes three notes.


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


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


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


I consider it is very important that we visualize carefully each of these requirements, without being confused by the way they are written and without mixing or entangling among them.


In that way we can establish the necessary elements in our quality management system, which allow us to meet each one of these requirements.


Now, in order to understand the meaning of these first requirements of the standard, it is important for us to remember the conceptual model of a quality management system presented by ISO 9001 standard, which is as follows:


If we take into consideration the information presented in this conceptual model, we can see that the initial stage of activities inside the quality management system is the one that refers to planning, both of the quality management system and of the processes, therefore all Clause 4. The organization and its context, including all its sub-clauses and requirements, refer to readiness activities to include those planning inputs.


It is important to understand this consideration with respect to requirements of the aforementioned Clause 4, that if the requirements established in their corresponding sub-clauses are not properly met, the organization will surely have problems to carry out a valuable planning.


As I have already mentioned in a previous post, something that I have observed in my professional experience is that this Clause 4 is, of all clauses of ISO 9001: 2015 standard, the least understood by the organizations that have established and even certificated, their quality management systems, and for the same reason, in which there are more non-compliances or true non-conformities, although both internal or external auditors (on behalf of organization´s customers), as well as the evaluators of certification bodies are not interested or do not have the knowledge to identify them correctly, and from what I have seen, this clause does not seem to be of much interest to the accrediting bodies either, and that is why there are so many organizations with their management system certified, but without proper compliance with all of Clause 4 of this and other management system standards, mainly Sub-Clause 4.1.


I think a very important point is that, those of us who dedicate ourselves to these activities related to management systems based on standards, we must always bear in mind that the management of an organization, or in particular of any of its components or systems, is actually an art, which can be supported by scientific, technological, methodological and documentary elements. There are many people immersed in this environment of management systems, mainly those who have not been trained in management skills, who see this as if it were a kind of cooking recipe; that is, by combining some ingredients and applying some odd technique, the organization will be managed appropriately. Nothing further from reality, most of these people can fully understand how closed systems work, without understanding that management systems are open systems, so there are innumerable factors, including the human one, which can affect them. This is a simple personal appreciation.


The establishment of objectives is a basic element, besides a requirement of any management system or of the organization in general, since all other activities that are going to be carried out by the organization will be to meet and verify compliance with those objectives. However, no auditor or certification body will be able to qualify if these objectives are well or badly established, since they are elements of the strategic direction of the organization itself. However if, on the one hand, those objectives are very lax, or low, it will require very little effort on the part of the organization to meet them, but most likely its stakeholders would be dissatisfied with its performance. But, in the other hand, if those objectives are too high and restrictive, it would most likely be that no matter how hard the organization strives, it would not be able to achieve them, which would be generating annoyance and frustration among managers and staff.


Each objective established by an organization for its quality management system, represents a possible result that should be desirable and attainable. If any of these objectives turn out to be undesirable or unattainable, the organization will run into trouble.


This is the importance of requirements included in Clause 4, in general, and particularly in Sub-Clauses 4.1 and 4.2. If an organization complies with those, it will facilitate that objectives, that will be established in the planning stage (Clause 6 of the standard), will be more likely to meet both conditions, desirable and attainable.


If we consider the part of strategic planning of an organization, the so-called strategic direction must carry out the set of activities that are required in an organization, based on its mission, taking into account the vision and, where appropriate, values ​​that have been recognized, in order to identify and establish general objectives and quality policies, collectively referred to as "quality policy". Based on these general quality objectives, the strategic direction of the organization must deploy its specific objectives (operational planning), and from there establish its operational plans and quality goals (tactical planning). And precisely that is what these requirements of the standard are about, to establish mechanisms or methodologies so that organizations can identify all those factors that affect, favourably or unfavourably, in their strategic planning, and can evaluate those possible positive or negative impacts, to achieve greater precision in setting their quality objectives.


We can visualize this process as follows:


It is important that the organization has defined, and you were aware of, its organizational structure, composition of senior management, basic elements of its strategic and operational planning, including its actual performance data as well as relevant references of the industrial sector in which the organization operates, and information of relevant aspects at the local, national and international level that have an impact on the activities, performance and competitiveness of this organization referring, in this case, mainly to the concept of quality. These elements are essential in order to meet these first requirements.


When the organization carry on strategic planning, all these issues, both external and internal should be considered, since if the organization can appropriately identify all factors influencing, both positively and negatively, its performance, it will be able to establish in the best way those objectives of its quality management system.


In part 3 of this post, I will conclude this analysis of the requirements of Sub-Clause 4.1 of ISO 9001: 2015 Standard.





Ernesto Palomares Hilton


  1. Great explanation. Indeed, most organisations do not understand this clause and also auditors don't know what to ask or look for when auditing it.


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