ISO 9001: 2015 - The basics



Welcome to this blog, in which we will be presenting information derived from management system standards, with the intention of facilitating its understanding and use to successfully  establishimplement and maintain this type of system.


You are most likely aware that there are currently millions of organizations around the world that have established and are operating management systems, using and applying one or more of these standards. But what you almost certainly do not know is that most of those millions of  organizations are not applying these standards  properly, and this is mainly because the people responsible for their application do not understand them correctly, even though they have all the related information in their hands.


That is why in this blog we will be presenting to you, and also analyzing, the information of these  standards, so that all those interested can understand them and that from there their correct application is facilitated.


To establish and operate a management system  based on a standard requires a significant use of resources by the organization, as well as a great effort from all the personnel involved. If this effort is adequate, the operation of the management system will bring great benefits to the entire  organization that applies it, as well as advantages for its staff. But on the other hand, if that effort is inadequate, even if it is massive, the system will entail the use of practically the same resources, but much less benefits for the organization, and almost the same great effort of the personnel at the beginning, which will later be much greater, but with little or no benefits to such personnel.


That is why it is worth making the effort to properly understand the management system standard or standards that the organization  decides to use.


On this occasion, I invite you to start with the analysis of the ISO 9001:2015 standard, a subject that is already well known, but which is so well known that it is worldwide, sometimes it seems that each person understands it in their own way, even when its elements are common; By this I mean the aforementioned ISO 9001:2015 standard and what a quality management system should be in compliance with the requirements of this  standard.


I will start by commenting that, as you probably know, the ISO 9001 standard is a document whose current version is the one published in 2015, and which is equivalent to the fourth revision of the standard originally approved and published in 1987.


If you analyze the texts of these two standards, the first version and the current one, it might seem to you that they are two different standards that deal with different topics. Both the focus of the  standard itself, the introductory elements and those referred to, as well as the identification and description of its requirements differ greatly, even when its orientation and objective do not change so much. The evolution shown by this standard is equivalent to what both people and organizations  have increased in recent years in their knowledge and experience in handling the elements that make up a quality management system, as well as to clarify those specific points that are commonly difficult for them to understand and apply correctly, or that at some point have generated important doubts.


As an example, we can mention that this  standard was originally considered to establish  requirements for a quality assurance system  aimed at generating trust in its customer, based on an established contract, and that in its latest version, and already since some previous ones, establishes  requirements for a quality management system, aimed at generating trust in its customer, but also in its interested parties, which may include its staff, its managers, owners or shareholders, among other groups of people, whether or not there is a defined contractual situation.


This type of changing characteristics has led to the fact that over time adjustments have been made to practically all the original requirements of this standard, both in the way of identifying them and in presenting and writing them.


This is a natural process of improving a standard. If there is within the universe of application of a standard, continuously more knowledge and experience about its elements and applicability, improvements will be made continuously, not only to keep it current, but also so that the  organizations that apply it obtain greater benefits from it and further learning.


Parallel to this development that the ISO 9001 standard has had over time, some support methodological schemes and software products applicable to quality management systems have been developed to facilitate compliance with the various requirements of this standard. In my opinion, most of these methodologies and products may generate benefits to the organizations that apply them, if they are used appropriately.


However, if you are a professional of quality and have a particular interest in one or more of the methodological schemes and innovative software products applicable to quality management systems, learn how to use them, apply those that are useful to you, but I recommend that you do not stop giving importance to what it requires, both the knowledge of what a quality management system  is, and an adequate understanding of each of the requirements of the ISO 9001 standard, as well as knowing and understand the other elements of this standard which, although they are not  requirements, are very important for its proper understanding and application. I am referring to the introductory and complementary elements of this standard, as well as those of the ISO 9000:2015 standard, which are referenced in ISO 9001 itself.


Something important that we should know is that in order to apply a standard properly, it is as important to understand the text of that  standard  as its context. This is something very valuable, and generally applies to all standards, including ISO 9001. However, it is very common for many professionals in the field of quality management  to go to great lengths to read and understand the technical elements of the standard, its  clauses and requirements, and that leave aside, as if it did not exist, the context and of this standard.


So, if we start the review of the ISO 9001 standard, it is good that we can know what the same International Organization for Standardization (ISO) presents in relation to the ISO 9001 standard.


If we take what refers to the standards of quality management systems, it tells us that a quality management system is the way in which an organization manages the interrelated parts of its business to achieve its quality objectives. These objectives may include aspects of the quality of your products or services, as well as the operational efficiency to achieve them.


The level of complexity of a quality management system will depend on the specific context of each organization. For some organizations, especially smaller ones, it may simply mean having strong leadership from the business owner, providing a clear definition of what is expected of each individual employee and how they contribute to the overall objectives of the organization, without the need for a extensive documentation. More complex companies operating, for example, in highly regulated industries, may need extensive documentation and controls to meet their legal obligations, as well as their organizational objectives.


The ISO 9001:2015 standard specifies the requirements for a quality management system when an organization:


a) needs to demonstrate its ability to consistently provide products and services that meet applicable legal and regulatory requirements of the customer, and


b) aims to improve customer satisfaction through the effective application of the system, including processes for system improvement and ensuring compliance with customer and applicable legal and regulatory requirements.


All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.


Let us now see some of the fundamental concepts of quality management systems, as they are considered in the ISO 9000: 2015 standard:




According to the reference standard, a quality-oriented organization promotes a culture that results in behaviours, attitudes, activities and processes to provide value by meeting the needs and expectations of customers and other relevant interested parties.


It also mentions that the quality of an organization's products and services is determined by the ability to satisfy customers, and by the intended and unforeseen impact on relevant interested parties.


It indicates that the quality of products and services includes not only their intended function and performance, but also their perceived value and benefit to the customer.


Quality management system


This ISO 9000 standard mentions that a quality management system (QMS) comprises activities through which the organization identifies its objectives and determines the processes and  resources required to achieve the desired results.


It also notes that the QMS manages processes that interact and the resources that are required to deliver value and achieve results for relevant  interested parties; that enables top management  to optimize the use of resources considering the consequences of their decisions in the long and short term; and that a QMS provides the means to identify actions to address intended and unintended consequences in the provision of products and services.


Context of an organization


Similarly, this standard tells us that understanding the context of an organization is a process. This process determines the factors that influence the purposeobjectives and sustainability of the organization. Consider internal factors such as the organization's values, culture, knowledge, and performance. It also considers external factors such as legal, technological, competitive, market, cultural, social and economic environments.

It is important not to be confused between the concepts of "context of the ISO 9001 standard" with that of "context of the organization"


It also clarifies that the visionmissionpolicies  and objectives are examples of the ways in which the purposes of the organization can be expressed.


Interested parties


The ISO 9000 standard points out that the concept of interested parties extends beyond the focus solely on the customer. It is important to consider all relevant stakeholders. That part of the  process for understanding the context of the organization is to identify its stakeholders. Relevant interested parties are those who create significant risk to the sustainability of the organization if their needs and expectations are not met. Organizations define what results are necessary to provide to those relevant interested parties to reduce that risk.


Organizations must attract, win, and retain the support of the relevant stakeholders on whom they depend for their success.




Indicates this standard, in general, the support of top management to the QMS and the commitment of people allows the provision of human resources and other adequate resources, the monitoring of processes and results, the determination and evaluation of risks and  opportunities, as well as the implementation of appropriate actions.


It also mentions that the acquisition, deployment, maintenance, improvement and responsible final disposal of resources support the organization in achieving its objectives.


In the same way, it points out that people are essential resources for the organization. It mentions too that performance of the  organization depends on how people behave within the system in which they work. And also that in an organization, people are committed and aligned through a common understanding of the quality policy and the results desired by the organization.


QMS is most effective when all employees understand and apply the necessary skills, training, education, and experience to perform their  roles and responsibilities. It is the responsibility  of top management to provide opportunities for people to develop these necessary competencies.


This same standard mentions that awareness is achieved when people understand their  responsibilities and how their actions contribute to the achievement of the organization's objectives.


It also points out that planned and effective  internal (i.e., throughout the organization) and  external (i.e., with relevant interested partiescommunication fosters people's engagement and increases understanding of: the organization's contextneeds and expectations of consumers and other relevant interested parties, as well as the quality management system itself.


Counting on this preliminary, but fundamental information, in the following entry we will delve into the context of the ISO 9001:20015 standard.





Ernesto Palomares Hilton