ISO 9001:2015 - 4.1 Understanding the organization and 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 the standard ISO 9001: 2015 incorporates, and we will start with the topic of Understanding the organization and its context, according to the requirements established in sub-clause 4.1 of the standard.

In previous posts we have analysed the context of the 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 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 one 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 must remember what is established in the Clause Introduction, 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 must ensure that we correctly identify and apply all requirements, that is, always the term "shall"  appears in the standard.

It is also important to remember that in the same Clause Introduction 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, leadership, engagement to people, process approach, improvement, evidence-based decision making and relationship management. These principles must 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 must be considered by the personnel who lead and operate the establishment, implementation, audit and improvement of a quality management system, 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 perform 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 must 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 appropriate use.

 

- Ethics:

As a basis for professionalism, the personnel who lead and operate the establishment and implementation of the quality management system in the organization must 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 a 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 situation generally leads to insurmountable problems for organizations in terms of their quality management systems.

Therefore, we will start with the content of Clause 4 of the ISO 9001: 2015 standard, which is the one corresponding to: Context of the organization. This time we are beginning to deal with Subclause 4.1. Understanding of the organization and its context, and I will take the opportunity to present to you the method that I personally apply to support my customers in the establishment of their quality management systems.

 

Requirements analysis method:

 

Step 1.- Make an exhaustive breakdown of the requirements of the standard.

As a first recommendation, in my opinion, for the identification and understanding of the different requirements established in the standard, it is precisely to identify them in an appropriate way, that is, to specify the scope of each of the established requirements.

There are people who have the responsibility of establishing and implementing quality management systems, as well as many consultants in this field, who generate a list of all the "shall" that each clause of the standard indicates, to avoid that any of the these are left out of the system. This is a valuable exercise, but, in my opinion, it is not clear enough, since in many cases the clauses of the standard indicate a requirement (“shall”), referring to two or more elements in the same sentence, or covering several paragraphs, which can lead to confusion and even non-compliance with some requirements. I suggest that you make an effort to understand the coverage of each of the requirements ("shall") that each clause, subclause or subsection contains, making an exhaustive breakdown and listing them individually so that you can understand, implement, verify, monitor and audit each one of them separately.

Bearing in mind this information, let's see what subclause 4.1 of the standard presents us, when establishing the first requirements of this standard:

 

The organization shall determine the external and internal issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended results of its quality management system.

The organization shall monitor and revise the information on these external and internal issues.

This subclause contains three explanatory notes, which must be considered when analysing the established requirements.

I invite you to do this exercise, that from the wording of subclause 4.1, presented above, break down all the requirements that are established there, and compare them with the identification that I will present to you in the following post.

It will continue in the post: ISO 9001:2015 - Understanding the organization and its context (Part 2).

 

Author:

Ernesto Palomares Hilton