ISO 9001: 2015 - Its context (part 1)


Welcome to this blog, where issues related to management systems based on standards are analyzed and discussed. I hope you can find valuable information for you.


In this entry we will begin analyzing the context of the ISO 9001 standard, and we will do it with the preliminary elements of this standard.


If you dedicate yourself or want to dedicate yourself professionally to the field of quality management supporting your organization, or others to apply this ISO 9001 standard, it is very important that you know and properly understand each of the requirements of this standard, either to comply with them correctly, or that you can offer a valuable audit, consulting or technical support service to organizations that operate in any economic field.


Personally, over a few decades now, I have met thousands of people whose professional performance is related to the ISO 9001 standard and, although I have met professionals with a high level of knowledge of this standard, in general most of these people have been concerned with reading and knowing some clausessub-clauses and subsections of the standard, but they generally fail to understand several of the various requirements that it establishes.


However, I have repeatedly mentioned in this blog that if someone wishes to correctly apply a standard like ISO 9001 it is important, in addition to identifying and understanding all  requirements of that standard, to also know its  preliminary and complementary elements, which are what make up its context. The preliminary elements are those that are presented in the  standard before the normative or technical content begins. The complementary elements are those that the standard presents after that  technical or normative content is concluded. If we know and understand this context of the standard, it will be easier to understand and be able to apply appropriately the different requirements that it presents.


In relation to the people who work daily with the ISO 9001 standard, which are millions, very few of them take the effort to know and understand the context of said standard. That is, they know the text (clausessubclauses and paragraphs) but not the context of this standard for the application of its requirements, which sometimes leads to making very costly mistakes in the development of a quality management system.


Due to the importance of these elements, we will begin the analysis of this context of the ISO 9001 standard.


The elements that make up the context of the ISO 9001:2015 standard, both preliminary and  complementary, that we will analyze before starting with the requirements of this standard, are the following:



- Code.


The first element of this context is the code of this standard, which is the following: "ISO 9001:2015".


This code is an identification element of the  standard. The standards issued by International Organization for Standardization (ISO) are basically identified by three components:


a) The first component consists of the short name of this organization, which is ISO.


b) The second identifier is a number, which corresponds to the order in which the standard is issued by this organization. In this case, for example, the number 9001 corresponded to it. The reason why it was assigned this number was simply because it was assigned after ISO 9000, and before ISO 9002.


c) The third identifier component is the one corresponding to the year of issuance of said standard. In this case, it was issued in 2015, and replaced the ISO 9001 standard issued in 2008.


- Title of the standard.


The second element of the context is the title of the standard, which in this case is: Quality management systems - Requirements.


What this title indicates to us from the outset is that it is a standard that covers the aspect of  management systems, which, within this universe, contains information on the discipline of quality, and which establishes requirements, which makes it a certifiable standard.


- Foreword.


The third preliminary element is the Foreword, a field that describes the organization that has issued this international standard, which is the ISO, indicating which part of its structure is responsible for the development of the standard, as well as some basic elements for its structure and writing.


It tells us that the ISO (International Organization for Standardization) is a worldwide federation of national standards bodies  (ISO  member bodies). The work of preparing  International Standards is usually carried out by  ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that  committeeInternational organizations, public and private, in coordination with ISO, also participate in the work. ISO  collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.


It explains that part 1 of the ISO/IEC Directives describes the procedures used to develop this standard and for its subsequent maintenance. In particular note should be taken of the different approval criteria required for different types of ISO documents. This standard was drawn up in accordance with the editorial rules of Part 2 of the ISO/IEC Directives.


Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO does not assume responsibility for the identification of any or all patent rights. Details of any patent rights identified during the development of this standard are indicated in the introduction and/or in the ISO list of patent declarations received.


Any trade names used in this standard are information provided for the convenience of the user and do not constitute a recommendation.


For an explanation of the meaning of specific  ISO terms and expressions related to conformity assessment, as well as information on ISO's  adherence to the World Trade Organization (WTO) Principles regarding  Technical Barriers to Trade (TBT), see the following URL:


The technical committee responsible for the development of this standard is ISO/TC 176, Quality management and assurance, through its Subcommittee SC 2, Quality systems.


It tells us that this fifth edition cancels and replaces the fourth edition (ISO 9001:2008 Standard), which has been technically revised, by adopting a sequence of revised chapters and adapting the revised quality management principles and new concepts. It also cancels and replaces the Technical Corrigendum ISO 9001:2008/ Cor.1:2009.


With all this information, you can find out who elaborates this standard, under what criteria, which is the current version, among several other elements that you can access in greater depth.


Regarding the Foreword to the Spanish version, it indicates that this International Standard has been translated by the Spanish Translation Task Force (STTF) Working Group of the ISO/TC 176 Technical Committee, Quality management and assurance, in which representatives of the  national standardization organizations and representatives of the business sector of the following countries participate:


Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador, Spain, United States of America, Honduras, Mexico, Peru and Uruguay.


Likewise, representatives of COPANT (Pan American Commission for Technical Standards)  and INLAC (Latin American Institute for Quality) participate in the aforementioned Working Group.


This translation is part of the result of the work that the ISO/TC 176 Group has been developing since its creation in 1999 to achieve the unification of terminology in Spanish in the field of quality management.


This translation work, if another language is used in your country, maybe is not important, but for countries where Spanish is spoken, it has been a very important job, because originally, the  standards issued by ISO come in three languages: French, English and Russian. For publications in other languages, the necessary translations must be worked on. In the case of these countries in which the Spanish language is spoken, those who were interested in the ISO standards carried out the corresponding translation of the first two versions, and it really seemed that each of these  standards were translated into a different language. And this caused the concept of international  standard to be lost for a while. The Mexican standard “equivalent to ISO 9001” was very different from the Chilean standard “equivalent to ISO 9001”, and both were very different from the Spanish standard “equivalent to ISO 9001”, and this was repeated for each country. For this reason, it was very important that the Spanish Translation Task Force (STTF) working group was created in 1999 within the Technical Committee ISO/TC 176, Quality management and assurance, since since 2000, when the third version of this standard was published, all Spanish-speaking countries have the same text.


Now, I am presenting to you some information about the Introduction clause. As I have mentioned in another entry, when it is considered relevant to develop an introductory element when developing a standard, either to contextualize or give an explanation that is considered valuable for understanding and applying the requirements that will be presented in that document, this  introductory information should not be considered as a technical element or  requirement of said standard, and therefore it is presented with number 0 or not a number at all. We then begin with the analysis of clause 0 Introduction of ISO 9001Curiously, this clause does not have the number 0 or any number marked in the text of the standard, but all its sub-clauses are identified with this number, and that is why we consider it with the number 0 and that it does not form part of the technical content of the standard.


Due to the large amount of information that has been considered should be placed in this Clause Introduction, it has been displayed in four sub-clauses, which are the following:


- 0.1 General,


- 0.2 Quality management principles,


- 0.3 Process approach, and


- 0.4 Relationship with other management system standards.


The first point worth mentioning about all the information contained in a standard like this one is that the text should be as simple and clear as possible. The information should not be duplicated or contrasted. It is not allowed to include excessive wording, that is, long descriptions of some  element or requirement, or abundant descriptions or explanations about it. The requirements of a standard are presented in a concise manner, and in the event that any additional explanation is required, “explanatory notes” are used, in the plainest way that can be described.


It is due to this form of presentation of information in a standard that we commonly find it difficult to fully understand what some requirement  establishes. Therefore, we should carefully read and understand what a standard establishes in each of its requirements. That is why there are  organizations that offer courses in interpreting  requirements of certain standards.


The Sub-clause 0.1 General presents the following concepts, which all of them should be understood by any person who is going to participate in establishingimplementingmaintaining or improving a quality management system, about what it is, what it can do for us and what it should not be considered this type of system; its rational basis and how to understand its requirements:


The sub-clause 0.1 mentions that adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives.


It says that potential benefits to an  organization of implementing a quality management system based on this standard are:


a) The ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;


b) Facilitating opportunities to enhance customer satisfaction;


c) Addressing risks and opportunities associated with its context and objectives;


d) The ability to demonstrate conformity to specified quality management system  requirements.


This standard can be used by internal and external parties.


It is not the intent of this standard to imply the need for:


— Uniformity in the structure of different quality management systems;


— Alignment of documentation to the clause  structure of this standard;


— The use of the specific terminology of this standard within the organization.


It states also the next concepts:


The quality management system requirements  specified in this standard are complementary  to requirements for products and services.


This standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.


The process approach enables an organization to plan its processes and their interactions.


The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement  are determined and acted on.


Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of  opportunities as they arise.


Consistently meeting requirements and addressing  future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization.


In this standard, the following verbal forms are used:


Information marked as “Note” is for guidance in understanding or clarifying the associated  requirement.


Sub clause 0.2.- Quality management principles


This standard is based on the principles of quality management outlined in ISO 9000: 2015. The descriptions include a statement of each principle, a rational basis for why the principle is important to the organization, some examples of the benefits associated with the principle and examples of typical actions to improve the performance of the organization when the  principle is applied.


In the standard ISO 9000: 2015 you will find a better description of these principles, and I hope you can analyze them in depth, but I include here the basic statement on each of these principles. Each of them, in addition to this statement, presents its complementary elements, as I mention you before: its rational basis, the key benefits that could be obtained and possible actions that  organizations can take to comply with them.


We can say that a principle is a subjective element that establishes a fundamental truth or  proposition as the basis for human behaviour, for a belief system, or for a chain of reasoning.


In the case of these principles of quality management, they are elements that give rationality and utility to a quality management system and without them it would be impossible to consistently achieve any benefit.


The principles of quality management are as follows:


— Customer focus: The primary focus of quality management is to meet customer requirements  and try to exceed customer expectations;


— Leadership: Leaders at all levels establish unity of purpose and direction and create conditions in which people are involved in achieving the organization's quality objectives;


— Engagement of people: Competent, empowered and committed people across the organization are essential to increasing the organization's ability to generate and deliver value;


— Process approach: Consistent and predictable results are achieved more effectively and  efficiently when activities are understood and managed as interrelated processes that function as a coherent system;


— Improvement: Successful organizations have a continuous focus on improvement;


— Evidence-based decision making: Decisions based on analysis and evaluation of data and information are more likely to produce the desired results;


— Relationship management: For sustained successorganizations manage their relationships with relevant stakeholders, such as suppliers.

In the next post, we will continue to discuss the Introduction element of this standard, as the rest of preliminary elements.





Ernesto Palomares Hilton