ISO 9001:2015 – 5.2.1 -Establishing the quality policy – Part 2


Welcome back to this page. I hope, as always, that the information presented here is of interest to you and that it helps to deepen your knowledge of ISO 9001:2015 and its requirements somewhat.


In the previous entry we carried out the analysis of the first three requirements of this section of the standard. If you want to access this text, click here.


In this entry I will continue with the analysis of the following nine requirements of this group corresponding to Section 5.2.1 Establishing the quality policy, which in turn is part of Subclause 5.2 – Policy, of this ISO 9001 standard.


It is important that when we consider  establishingimplementingverifyingreviewingauditing and maintaining the quality policy, we take into account all elements presented in that previous entry, as well as those presented in this one.


In order that you can identify all requirements that are broken down in this Section 5.2.1 of the ISO 9001 standard, I present the complete list again:


As I have mentioned in other entries regarding  requirement´s analysis of management system standards, we should be very careful when reading and trying to understand these  requirements, since the way in which the texts are presented in these  standards can lead to confusion, and when each  requirement is individually separated, it may appear that they are repeated. However, this is not so. Each of them establishes a different  specification from the others.


Allow me to present you as a simple example of this characteristic that I comment on in these  standards, considering only what refers to  subparagraph a) of this section. The text states the following:


Top management shall establishimplement  and maintain a quality policy that is appropriate to the purpose and context of the organization and supports its strategic direction”.


When reading this text, have you been able to identify the nine requirements specified here? And if so, would you be identifying each of them with the same level of importance?


Many people, when reading this type of text, subjectively establish a different level of importance to requirements, as they are presented in the text, considering that the first one that appears is the most important, and the others decrease in level of importance in progressive order. This phenomenon achieves that when trying to comply with these requirements in  organizations, they give preference to the first ones that are indicated in the text, and the others are given less relevance, and some of them are not even considered as specific requirements. That is, they become invisible to those organizations, and therefore there are requirements that have never been identified, so they are never met. And just as it happens with the personnel of the organizations, it also happens with the auditors, both internal and external, even if they are qualified, as well as with the evaluators from certification and  accreditation bodies.


This is the motivation I have had to carry out this type of analysis of requirements of these  management system standards, although it may seem excessive or repetitive, but in this way I can help all the people whose activity is related to this type of management system.


If you doubt what I am mentioning here, I suggest that you analyze the documentation of the quality management system of the organization in which you work and compare whether the first  requirement of this Section 5.2.1 is given the same treatment as the I presented in the previous entry, with No. 92, which states: "Top management shall establish quality policy that is appropriate to the purpose of the organization"


Now compare that description with the one corresponding to the requirement that I present to you in this entry, with No. 100, which is the last one that is presented in this subsection, and that says: "Top management shall maintain quality policy that support the strategic direction of the organization.


There you will see if the different requirements are given equal importance in your organization.


A very clear example in relation to what I am commenting on here, we can see in the Technical Specification ISO/TS 9002: 2016 - Quality management systems — Guidelines for the application of the ISO 9001:2015 Standard. In the previous post I presented what this  specification indicates in relation to Section 5.2.1, which states that the intent of this subclause is to ensure that a quality policy is established which aligns with the strategic direction of the organization, including the organization’s  overall understanding of what quality means to itself and for its customers. The quality policy  describes the intentions and direction of the  organization as formally expressed by its top management.


Interestingly, in this description it only refers to the quality policy being established, but it does not even mention that this policy shall be implemented and also maintained. And in the same way, in reference to subparagraph a) of the standard, it mentions nothing more than that said policy should be appropriate to the  organization and support the strategic direction, but it does not specify that it should be appropriate to the purpose and context of the organization.


That is where we find the main difficulty when an organization tries to establish a management system in accordance with this standard, not to identify all requirements or not to give the same importance for their identification and fulfillment.


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



Requirement No. 95: Top management shall implement a quality policy that is appropriate to the purpose of the organization.


What this requirement tells us is that once top management has established the quality policytop management itself should implement it. So that we all can understand this requirement clearly, I present the definition of this term:


Based on this definition, we can understand that top management should give practical effect to this policy, and ensure that it is accomplished throughout the organization, at all relevant levels and functions, each of the elements  (intentions  and direction) that make up said quality policy, and that are appropriate to the purpose of the organization. That is, that the entire operation of the quality management system and all its  processes, is oriented to fulfill the established  mission, with the identified values, and to achieve the vision in the expected time.



Requirement No. 96: Top management shall implement a quality policy that is appropriate to the context of the organization.


With the previous requirement we saw what the term “implement” means. Based on this definition, we can understand that top management should give practical effect to this policy, and ensure that it is accomplished throughout the organization, at all relevant levels and functions, each of the elements (intentions and directionthat make up said policy, and that they are appropriate to the context of the organization.



Requirement No. 97: Top management shall implement quality policy that supports the  organization´strategic direction.


When analyzing requirement No. 95 we saw what it means to "implement" the quality policy, and with requirement No. 94 we saw what the  strategic direction of the organization is.


So, to meet this requirement, it is important that when top management is implementing this  quality policy, it ensures that this implementation supports the formulation of the strategic plan, as well as the deployment of that plan through the specific objectivesplansgoals and design and operation of the processes.



Requirement No. 98:  Top management shall maintain a quality policy that is appropriate to the purpose of the organization.


What this requirement tells us is that once top management has established and implemented  the quality policytop management itself should  maintain it. For this, I present the definition of this term:


This means that top management should preserve from failure or decline the quality policy, before any adjustment that should be made, for any change that may exist in relation to the purpose of the organization, in order for this policy to maintain its validity over time, and continue to be applicable for all relevant functions and levels.



Requirement No. 99: Top management shall maintain a quality policy that is appropriate to the context of the organization.


With the previous requirement we saw what the term maintain” means in relation to the quality policy. Based on this definition, top management  should preserve said policy, for any change or update that may have been generated in relation to the context of the organization, so that this  policy maintains its validity over time and continues to be applicable. for all relevant functions and levels, considering the review and updating of information sources for, where appropriate, considering the updating of internal and external issues determined by the organization that are relevant for its purpose and that affect its capacity to achieve the intended results of its quality management system, the needs and expectations  of interested parties, the scope of the QMS as set out in Sub-Clause 4.3and also the characteristics and processes of the QMS itself, as set out in Sub-Clause 4.4 of this standard.



Requirement No. 100: Top management shall maintain a quality policy that supports the  organization`s strategic direction.


When analyzing requirement No. 98, we saw what it means to "maintain" the quality policy, and with requirement No. 97 we saw what the strategic direction of the organization is.


So, to meet this requirement, it is important that when top management is carrying out the necessary actions to "maintainthis quality policy, it ensures that support for the reformulation of the strategic plan is “maintained”, as well as the deployment of that plan through the specific objectivesplansgoals and design and operation of the processes.



Requirement No. 101Top management shall establish a quality policy that provides a  framework for setting quality objectives.


This requirement also refers to establish  the  quality policy by top management, as we saw previously in the requirements numbered 92, 93 and 94, but in particular this requires that the aforementioned policy provide a framework  for establishing the objectives of the QMS.


If you have read the ISO 9001 standard, you will know that there is a Clause 6 - Planning, dedicated to this topic of QMS PlanningHowever, what we should understand with this requirement No. 101is that the quality policy should provide the basis for that planningThe important point in relation to this is: How can we identify that framework, within that policy, to establish  the  objectives of this management system?


Remember that when developing and issuing  management system standardsISO has not invented anything new, inventing is not its function. It has been selecting the best practices and integrating knowledge that for more than a hundred years has been developed in management areas, from the concepts of scientific management to date. The most relevant thing about these  standards is that they have identified some valuable elements of the administrative process  as standard requirements to integrate a  management system so that an organization that implements it can build confidence in its performance.


It is considered that for an organization  to  establish its objectives (specific or quantifiable), within any productive system, it should be able to count on some strategic elements on which to base itself.


We have already mentioned what the missionvision and values are, as well as the importance they have to identify the purpose of the  organization, that is, the justification for the existence of the organization, what it intends to achieve in the future, in a determined time and with what bases of behavior accepted by the  organization itself.


These elements are of a general type, basic for any organization, and do not have to refer to any particular management system. From this, top management should break down this purpose and specify other strategic elements, from general to particular, so that all corresponding areas, functions and levels of the organization participate actively to achieve this purpose.


After those three elements already mentioned  (missionvision and values), the next strategic level is commonly known as general objectivesTop management should identify all the general objectivesor global intentions, that are necessary for the organization to fulfill its purpose. As the name implies, these objectives have a broad coverage and do not need to be quantifiable. They may refer to any relevant item concerned with quality, such as productive areas of interest, investment and profit aspects, technological focus, competitiveness, among others, but it is important that there be one or more of them that are related to the quality management system.


The next strategic level is known as policies, which are the guidelines and direction elements that the organization establishes as general behavior guides for all the organization's personnel.


With respect to this requirement of the standard, what is needed is that top management issues a  documented statement, which the standard calls the quality policy, which should be made up of all the general objectives (intentions) and all  policies (guidelines, orientation or direction  elements) that guide the entire organization  towards where it should move forward and what is expected to be achieved in terms of quality.


Since the first version of ISO 8402 – Quality management and quality assurance — Vocabulary (now updated to ISO 9000: 2015), which was published in 1986, it was considered to use the term global intentions instead of general objectives, even if the concept was the same, to avoid confusion between the different levels of objectives (general or specific), as well as using the direction term instead of policies, to leave this term as identification of the requirement and the core strategic element of these management systems based on standards.


Based on these elements that make up the quality policy, the corresponding planning areas will have the appropriate framework so that from each of the intentions or general objectives established in the aforementioned policy, all the objectives  (specific ) necessary to comply with that intention, and that from each of these objectives  the planning of all the activities necessary to comply with each one of them can be established, and by following the established guidelines (direction elements), they are fulfilled all the intentions (general objectives), and with that, the purpose of the organization can be achieved. All this, through appropriate processes  management.



Requirement No. 102: Top management shall implement a quality policy that provides a framework for setting quality objectives.


This requirement also refers to implement  the quality policy by top management, as we also saw previously in the requirements numbered    as 9596 and 97, but in particular this requires that when the aforementioned policy is implemented, it provides this appropriate framework for the formulation of the strategic plan, as well as its deployment in the objectives of the quality management system.



Requirement No. 103: Top management shall maintain a quality policy that provides a  framework for setting quality objectives.


This requirement also refers to maintain the  quality policy by top management, as we also saw previously in the requirements numbered  as 9899 and 100, but in particular this  requirement specifies that when the aforementioned policy is maintained, it continues to provide an appropriate framework for  establishing the objectives of the quality management system. This means that when the organization carry on updates to its  purpose (missionvision or values), or updates the elements that make up the context of the  organization, it should consider these adjustments in the maintenance of the quality policy, so that it continues providing an appropriate framework for the establishment or adjustment of quality objectives.


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


As always, I will be grateful to the readers who raise their doubts or comments about this analysis.





Ernesto Palomares Hilton