ISO 9001 - 4.1 - Understanding the organization ant its context (Part 1)

In this post we will be applying a detailed analysis method that can be used for each of the clauses, subclauses and subsections that ISO 9001: 2015 standard incorporates, and we will start with the topic of Understanding the organization and its context, according to requirements established in sub-clause 4.1 of that standard.

In previous posts we 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 0 Introduction, 1 Scope, 2 Normative references, 3 Terms and definitions, and ending with complementary elements, such as the bibliography and informative annexes of the mentioned standard.

I have received some comments and suggestions, which I really appreciate, in which they have asked me to perform a deeper analysis of the requirements of the ISO 9001 standard, which I will do in the best possible way, expecting that what I present here could be useful in your professional activities. We will be carrying out this analysis in the different management system standards, so in those clauses that make up the High Level Structure (HLS) there will necessarily be great similarities, although they may also have some differences, depending on the nature of the management system.

For this reason, we will begin with that deeper analysis of the text of the standard; that is, of the normative elements that make up the technical body, included in clauses 4 to 10 of this  ISO 9001: 2015 standard,  which I present below:

We are starting from the basis that this standard, in general, as well as each of the requirements established in it, they should generate value for the organization that implements them appropriately within its quality management system. In order to understand the meaning and value of these requirements, it is important to establish a method for this analysis that should be supported by in-depth knowledge of quality management systems and their supporting elements.

Personally, I have used my own method to support the organizations I have worked with, which consists of seven steps for the correct implementation of the requirements. I will gladly share with you the first three steps of this method, hoping it will serve as additional support to what you apply in your activities, especially those who carry with managerial activities on the establishment, operation and improvement of a quality management system, as well as of those who audit this type of system. I believe that many of us who have participated in audits at QMS have been through situations in which there has been a great deal of anguish on the part of the person who receives the audit, or of great despair by the person conducting the audit, when the auditor requests evidence about a requirement that the organization has not specifically identified, so that the personnel attending the audit do not have or do not even know what kind of evidence could demonstrate compliance with that requirement, and the auditor, no matter how many times he or she rephrases his questions, feels that speaks in the emptiness. This is a situation that occurs commonly, even in organizations that have been operating their QMS for several years.

In order to carry out this analysis, we should remember what is established in the Introduction  Clause, which although it does not indicate any specific requirement, it provides us with a lot of information, which we should always take into account, among which it stands out that in this standard the following verbal forms are used:


Similarly, it clarifies that the information identified as "NOTE" is presented as a guide for understanding or qualifying the corresponding requirement. 

Therefore, if we want to implement a QMS we should ensure that we correctly identify and apply all times the term "shall" appear in the standard.

It is also important to remember that in the same  Introduction Clause of this standard, seven principles of quality management are established, which are described in greater detail in the ISO 9000: 2015 standard, namely: 

customer focus, 


engagement to people, 

process approach, 


evidence-based decision making, and

relationship management.

These principles should be considered and applied throughout the quality management system, so that it can generate value for the organization.

In addition to the aforementioned principles of quality management, it is important to consider other   three   application  principles  that  should  be considered by the personnel who lead and operate the establishment, implementation and improvement of a QMS, in order to carry out an adequate analysis of the different requirements of the ISO 9001: 2015 standard, and from this, a correct establishment, implementation, verification, monitoring (including auditing) and improvement of each of the elements to ensure compliance with the quality management system. These principles are as follows:



- Objectivity:

The main characteristic and value of a standard, such as ISO 9001: 2015, is its objectivity. It is intended that each requirement of the standard is established by the organization, clearly and unquestionably. To achieve this, it is essential that the people who lead and operate the establishment and implementation of the quality management system in the organization act according to objective criteria, that is, related to the object under consideration and never with the interested parties or with the personal feeling of the person who acts.


- Diligence:

The people who lead and operate the establishment and implementation of the quality management system in the organization should carry out their functions, in accordance with the responsibility that this implies and the trust placed in them by senior management. They must look for the necessary competence and keep it up to date.

A quality management system, in compliance with the ISO 9001: 2015 standard, is made up of a large number of elements that depend on details for their proper understanding and their establishment, implementation, verification, monitoring and improvement.


- Ethics:

As a basis for professionalism, the personnel who lead and operate the establishment and implementation of the quality management system in the organization should act in an ethical manner, identifying errors and correcting them, documenting non-conformities and seeking the best solutions through corrective actions. even if they had been by fault of their own.

One of the most common problems that organizations face with their quality management systems is caused by their staff doing everything possible to hide their failures, for fear of being reprimanded or sanctioned by their supervisors. This is a problem both of an organizational nature that does not provide confidence to its staff to overcome limitations in terms of their competencies, and of an ethical nature of the staff, which prefer to cause harm to the organization before exhibiting their own limitations.

Something similar happens with those who make up the top management, or those who lead the establishment, operation and improvement of the quality management system, who sometimes find elements related to their responsibilities, which they do not completely understand or not understand them at all, and apply them in a wrong or limited way, before recognizing their urgent need to upgrade their skills in order to improve their performance. This uncompetence and lack of ethics of top management generally leads to insurmountable problems for organizations in terms of their quality management systems.

Therefore, we will start, in the next post: QMS - Understanding the organization and its context (Part 2), with the Subclause 4.1 of ISO 9001: 2015 standard.


Ernesto Palomares Hilton