ISO 9001:2015 – 5.2.1 -Establishing the quality policy – Part 1



You are welcome to this page, a blog in which we break down and analyze the information presented in the management system standards, in order to increase our knowledge about them and that they can be applied in the best way. I hope that the information presented in this post will be of interest to you and that it will somewhat enrich your knowledge of ISO 9001:2015 standard and its requirements.


In this entry we begin the analysis of the groups of requirements corresponding to Sub-clause 5.2 – Policy of ISO 9001: 2015 standard, so we will begin with Section 5.2.1 Establishment of the quality policy. This section, which in the standard is presented in a small paragraph and four subsections, when applying the methodology that we usually use to break down the text of sub-clauses, in this type of standard, becomes in eighteen requirements, which are all important so that an effective and high-value quality management system can be establishedDue to the great importance of these requirements, in this post we will analyze the first three of them, which are the most complicated to analyze, in order to facilitate their understanding. We will be analyzing the rest of those requirements in the following two posts.


However, before beginning with this analysis of requirements of Section 5.2.1, it is important to present to you some useful preliminary information for a better understanding and application of the requirements of all this Sub-clause 5.2, and of which little is mentioned in relation to this ISO 9001 Standard.


First of all, it is important to consider that in its Clause 3 - Terms and definitions, the ISO 9000 Standard, in its Subsection 3.5.8, presents the term "policy" and defines it as follows:


We can understand this in a better way, if we consider that intention is a word which means what one intends to accomplish or attain”; and we can understand by direction: guidance or supervision of action or conduct.


In its next subsection, 3.5.9, this standard presents the definition of the following term:


Along with this definition, the ISO 9000: 2015 standard presents the following explanatory notes:


Note 1 to entry: Generally the quality policy is consistent with the overall policy of the organization, can be aligned with the organization’s vision and mission, and provides a framework for the setting of quality objectives.


Note 2 to entry: Quality management principles presented in this International Standard can form a basis for the establishment of a quality policy.


These terms lead us to consider that the policy, in this case of quality, should integrate a series of elements: on the one hand, those that identify the "intentions" of the organization in terms of quality, which can be from a single intention, to all those that the organization can identify as desirable or necessary. On the other hand, this policy should integrate as well, all the direction elements that it considers relevant in this matter of quality.


The top management of an organization that establishes a quality management system in compliance with ISO 9001 standard should take into account that the quality policy is a strategic element of great importance so that said system can be valuable to the organization itself. In fact, for the quality management system, the quality policy is the most important strategic element, because all other activities that are going to be carried out within that system should be aimed at complying with that policy. Of course that there are strategic elements of a higher level than this policy, such as the mission, vision and values, but these are above this management system, and it is the policy that should be aligned with those elements.


Similarly, it is very important to understand that this quality policy is a statement that should be issued by top management and contain various components, including intentions and direction elements, in accordance with the requirements of this Section 5.2.1.


However, a common flaw in organizations that apply these quality management systems, based on the ISO 9001: 2018 standard, is that the quality policy they establish are not elements generated by top management, but rather by some operational-type mid-level official, perhaps with the participation of some technical manager and, therefore, these policies do not integrate either the intentions or the direction elements that should be established and formally expressed by top management. So, they are elements that do not really make up a quality policy, according these requirements, but some statement that contains some phrases, more motivational than guiding, with the intention of meeting with a requirement of the standard, but that are far from complying with all requirements established for said policy. In most of these cases, these policies do not meet the definition presented above, nor do they contain the intentions or the direction elements that can serve as a guide to the entire organization in terms of quality, nor do they meet the requirements contained in this Section 5.2.1 of the standard, which we will see in this post, and which very few people and organizations take into account.


After this brief introduction to the subject, we begin with the analysis of the requirements related to the quality policy that I will analyze in this post, and which are the following:




As I have mentioned in other entries regarding analysis of requirements of management system standards, we should be careful when reading these requirements, since the way in which the texts are presented in these standards, when separating each requirement individually, seems that these are repeated. However, each of them sets a different specification from the others.


In accordance with Technical Specification ISO/TS 9002:2016 - Quality management systems — Guidelines for the application of ISO 9001:2015, the intent of this Section 5.2.1 is to ensure that a quality policy is established aligned with the strategic direction of the organization, including the organization's general understanding of what quality means to it and its customers. The quality policy describes the intentions and direction of the organization as formally expressed by top management.

The ISO 9001:2015 standard establishes the following requirements derived from the Section 5.2.1, and I present them with the corresponding progressive numbering, as I have been presenting all the requirements of this standard that I have been analyzing.



Requirement No. 92: Top management shall establish a quality policy that is appropriate to the purpose of the organization.


The first thing that this requirement establishes, and that is repeated in some subsequent ones that correspond to this sub-clause, is that top management should establish the organization's quality policy, but it also establishes that it should be appropriate to the purpose of the organization.


This leads us to identify the meaning of the word "establish", which we previously did in what corresponds to Sub-clause 4.4 of this standard:



Based on this definition, top management should develop and bring into existence a quality policy for the organization, and for this, it should take into account the definition, previously presented, of this term, so that it can be well established and be a valuable element of the quality management system.


The second element to consider from this requirement is that this quality policy should be appropriate to the purpose of the organization. However, a question could enter here: What is the purpose of an organization? How can we find it, understand it or know it?


I have read and analyzed many ISO management system standards, and I have not found a single one of them that defines the concept of purpose, although it is included in all of these standards.


However, if we investigate enough, we can find some answer, and in this case we found the standard ISO 37000:2021 -Governance of organizations — Guidance, which presents the following definition:


This definition is presented with two notes:


Note 1 to entry: The organizational purpose is the ultimate value the organization intends to generate for specified stakeholders.


Note 2 to entry: The organizational purpose guides the performance objectives and provides clear context for daily decision-making by relevant stakeholders.


Additionally, in the ISO 9000:2015 standard, two terms and their definitions are included that can shed some light on this concept:


If we add another term to these two, that is related to them, which is values, this one is not defined in the ISO 9000:2015 standard, but whose definition appears in the ISO 22316:2017 standard - Security and resilience - Organizational resilience - Principles and attributes, and is as follows:


Similarly, the standard ISO 37000:2021 - Governance of organizations — Guidance contains the definition of the following term, which although not identical to the previous one, is very similar and indicates the relevance of this concept:


Let's think that in order to have a reasonable expectation for an organization to operate in a valuable way, it should do some planning activities. But, for that organization to be able to properly carry out its planning, it should have some basic elements, such as mission and vision, and if possible with the identification of the relevant values for the organization, these three elements together are known as “purpose of the organization”. We can visualize this as follows:


We can consider that the purpose of an organization is identified from two key strategic elements for any organization, which are the mission and vision, which may be accompanied by another element, that we can consider as complementary, such as values, but which is important in guiding and supporting the behavior of the entire organization. These elements should be established by the owners and would mean why the organization was created (fundamental goal), and what would be the expectations of its performance in a certain period of time.


The fact that an organization should have identified a mission, vision and values, does not mean that they are specific requirements of the ISO 9001 standard, nor of any management system standard, since it is considered that every organization should have these elements identified and documented, before they even think about establishing their quality management system, and that they should be accessible to its entire staff. Also, it is considered that an organization could not perform in a successful way if it does not have these primary strategic elements. These elements can also be modified, either to redefine them, enrich them, or to redirect them.


It would be expected that this purpose would establish the reason that justifies the existence of an organization based on three elements: its profits, its impact on society, and its impact on the people that comprise it.


Once the concept of organizational purpose is understood, top management should ensure that the quality policy is appropriate and aligned with these elements. This would mean that by consistently applying and complying with this policy, the organization would be getting closer to fulfilling that purpose.


The technical specification ISO/TS 9001:2018 - Quality management systems — Guidelines for the application of the ISO 9001:2015 indicates that in order to establish the food safety policy, entries such as the following may be taken into account:


— a clear understanding of the context of the organization, including the current performance of its management system and the needs and expectations of its relevant interested parties;

— the organization’s strategic direction, based on its mission, vision, guiding principles and core values;

— the level and type of future improvements needed for the organization to be successful;

— the expected degree of customer satisfaction;

— the resources needed to meet intended results;

— the potential contributions of relevant interested parties.


Requirement No. 93: Top management shall establish a quality policy that is appropriate to the context of the organization.


We already saw with the previous requirement what it means for top management to establish a quality policy. In addition to that, the requirement establishes that this policy is appropriate to the context of the organization.


For this, it is good to remember what the context of the organization means, in accordance with the ISO 9000:2015 standard.


This definition in the ISO 9000:2015 standard contains four notes, which contain important complementary information, and I present below:


Note 1 to entry: The objectives of the organization may be related to its products and services, investments and behavior towards its interested parties.


Note 2 to entry: The concept of context of the organization is equally applicable to not-for-profit or public service organizations as it is to those seeking profit.


Note 3 to entry: In English language, this concept is often referred to by other terms, such as “business environment”, “organizational environment” or “ecosystem for an organization”.


Note 4 to entry: Understanding the infrastructure can help to define the context of the organization.


Thus, this requirement indicates that this quality policy should be appropriate to this context of the organization, considering the internal and external issues, determined by the organization, that are relevant to its purpose and that affect its ability to achieve the expected results of its quality management system, as set out in ISO 9001 Sub-Clause 4.1. It should consider what the organization has determined in terms of the needs and expectations of its interested parties, as set out in Sub-Clause 4.2. This policy should also consider the scope of the QMS, as established in Sub-clause 4.3, and also the characteristics of the quality management system itself, as established in Sub-clause 4.4 of this standard.


This can be visualized as follows:



Requirement No. 94: Top management shall establish a quality policy that supports the organization`s strategic direction.


We have already seen with the previous requirements what it means for top management to establish a quality policy. In addition to this, this requirement establishes that this quality policy supports the strategic direction of the organization.


We have here a little problem. Although all management system standards refer to the concept of strategic management, none of them define this term. The ISO 9000: 2015 standard contains the definition of the following term:


And the ISO 21001: 2018 standard, mentioned above, indicates another definition of this term:


Another term that we find, but this time in the ISO 24513: 2019 standard - Service activities related to the supply of drinking water, wastewater and stormwater systems — Vocabulary is the following:


And another interesting definition is presented by the ISO 30400:2022 standard, on the following term:


However, even if the standards do not have this definition, if we search carefully, we can find one that can help us:


We can understand then, after this puzzle of definitions, that the strategic direction is the part of top management that is in charge of formulating the strategic plan and deploys the set of strategic elements that are generated from the organizational purpose (mission, vision and values), such as general objectives, policies, specific objectives, plans and processes.


The strategic direction formulates and implements the strategy, mobilizing the resources of the organization and attending to the complexity of the organizations and the environment. It should be a mixture of knowledge of the environment, a planned, organized, clear and responsible management with its resources, at the same time that it is assertive regarding what the organization should improve to increase its competitive capacity in the market and achieve excellent results.


Based on this strategic plan, the strategic management should develop, together with the operational areas of the organization, the tactical planning, and from this, the operational areas will develop their operational planning, including the goals (partialized specific objectives considering the time factor).


In the next entry we will continue with the analysis of requirements derived from Section 5.2.1 of ISO 9001:2015.


I will be grateful to the readers who upload their doubts or comments about this analysis.





Ernesto Palomares Hilton