ISO 9001: 2015 – Analysing the text – Clause 4. Context of the organization

 

With this post I begin the analysis of the different elements of  quality management systems that are established as requirements in ISO 9001: 2015 standard.

In previous posts I have analysed the context of this ISO 9001: 2015 standard, from the information with which the International Organization for Standardization (ISO) presents on its website both the management system standards, and this standard in particular, passing 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 the complementary elements, such as the bibliography and the informative annexes of the standard.

In this post I begin the analysis of the text of the standard, that is, of the elements that make up the technical body of the standard, which are those that comprise clauses 4 to 10. Therefore, this time we begin with the content of the first of these, which is Clause 4.

 Context of the organization.

I consider it important to clarify, at the beginning, that when I have referred to the context, in previous posts, it has been in relation to the content of the ISO 9001: 2015 standard, to all the information that this standard provides, both preliminary and complementary, but it is not part of the clauses that contain requirements, that is, it is outside the normative content of this standard.

Obviously, this Clause 4 refers to the context of an organization that would be establishing a quality management system using the ISO 9001:2015 standard, and not to the elements of the standard itself. I hope I am not confusing you with the handling of this term.

Now, when starting the analysis of those clauses that contain requirements, the normative body of this ISO 9001: 2015 standard, as I mentioned previously, we find that Clause 4, the first of this group, which is called “Context of the organization”, which is made up of four sub-clauses, which are the following, that I present to you in the next figure, and with their corresponding text:

4.1 Understanding the organization and its context.

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

The organization shall monitor and review information about these external and internal issues.

NOTE 1 Issues can include positive and negative factors or condition for consideration.

NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, social and economic environments, whether international, national, regional or local.

NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

 

4.2 Understanding the needs and expectations of interested parties

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that customer and applicable statutory and regulatory requirements, the organization shall determine:

a) the interested parties that are relevant to the quality management system;

b) the requirements of these interested parties that are relevant to the quality management system.

The organization shall monitor and review information about these interested parties and their relevant requirements.

 

4.3 Determining the scope of the quality management system

The organization shall determine the boundaries and applicability of the quality management system to establish its scope.

When determining this scope, the organization shall consider:

a) the external and internal issues referred to in 4.1;

b) the requirements of relevant interested parties referred to in 4.2

c) the products and services of the organization.

The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.

The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and

services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.

Conformity to this International Standard may be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.

 

4.4 Quality management system and its processes

4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the process needed and their interactions, in accordance with the requirements of this International Standard.

The organization shall determine the process needed for the quality management system and their application throughout the organization, and shall:

a) determine the inputs required and the outputs expected from these processes.

b) determine the sequence and interaction of these processes;

c) determine and apply the criteria and methods (including monitoring measurements and related performance indicators) needed to ensure the effective operation and control of these processes;

d) determine the resources needed for these processes and ensure their availability;

e) assign the responsibilities and authorities for these processes;

f) address the risks and opportunities as determined in accordance with the requirements of 6.1 ;

g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;

h) improve the processes and the quality management system.

4.4.2 To the extent necessary, the organization shall:

a) maintain documented information to support the operation of its processes;

b) retain documented information to have confidence that the processes are being carried out as planned.

 

If you do not have prior knowledge of what the ISO 9001: 2015 standard is about, and your boss assigns you the responsibility of ensuring that the organization in which you work fully complies with this Clause 4 of the standard, with what you have already read up to at this moment, I imagine that you would be looking for a corner where you could sit and cry out of despair of not understanding any of those requirements. Therefore, it is important to obtain sufficient knowledge about what a quality management system is and about this standard, either from a leader within your organization, who has the knowledge and patience to instruct you, or through of a course or training program that provides you with this knowledge and a little experience in its analysis, in order that you can understand these requirements, and from there, establish the elements in your quality management system, that meet those requirements appropriately.

When we start a project, as I have already mentioned in a previous post, for the establishment of a quality management system, either internally from the organization or with external support, we usually start to work identifying the resources that we have, those that we are going to need, the time that each stage of the project will take, as well as the results that we expect from each of them and we start bravely, but generally a little clumsy, to face each of the requirements established by the ISO 9001: 2015 standard and to generate supporting documents (documented information). However, something that we generally do not do is try to understand the basic concepts of quality management systems and how we can identify and fit that quality management system complying with all applicable requirements of ISO 9001: 2015 standard within our organization.

From this, the first step is for us to understand that any productive organization is itself a system, which is made up of various components, and from a series of system inputs, which are basically the productive resources it requires, be it material, human, financial or information, which will be used and transformed by the organization itself, to generate a series of outputs, which will be mainly the products or services that it supplies to its customers, but it should also generate satisfaction among all the people who participate, promote the survival and growth of the organization, as well as a spill of benefits to society. We can visualize this in the following way:

In the same way, if we can thus understand a productive system, regardless of the size or complexity of the organization, its productive sector, technological level, competition in markets, among other characteristics, it will also be made up of a series of components or subsystems, which They may vary depending on the type and complexity of the organization, but it will have at least the five basic subsystems, as we can see below:

Now, if you have read carefully the elements of the context of this standard, you will remember that the Introduction Clause presents a conceptual model of the quality management system established by the ISO 9001: 2015 standard, which I present below:

Considering the information contained in this conceptual model, we can see that the initial stage of the activities of the quality management system is the one that refers to the planning, both of the quality management system and of the processes, so all Clause 4 The organization and its context, including all its sub-clauses and requirements, refers to preparatory activities to carry out such planning.

It is important to understand this consideration with respect to the requirements of the aforementioned Clause 4, that if the requirements established in the corresponding sub-clauses are not properly met, the organization will surely have problems to carry out a valuable planning.

I clarify this point, since what I have observed in my experience is that this Clause 4 is, of all the clauses of the ISO 9001: 2015 standard, the least understood by the organizations that have established and even certified their quality management systems, and therefore, in which there are more real non-conformities, although both the internal auditors and the evaluators of the certification bodies are not interested or do not have the knowledge to correctly identify them, and therefore I have seen, this clause does not seem to be of much interest to the accrediting bodies, in terms of its proper compliance, and that is why there are many organizations with certified quality management systems, but without proper compliance with all the Clause 4 of this standard.

To mention it clearly, in accordance to ISO 9001:2015 standard, the context of the organization is the set of all factors that can interfere, either to favor or harm, the performance of the organization, and therefore they can affect the proper establishment of quality objectives. We can visualize this as follows:

Source: E. Palomares Hilton

To begin this analysis, we must remember what is indicated in the Introduction Clause, which although it does not establish any specific requirement, it mentions something that we should always bear in mind, and is that in this standard the following verb forms are used:

 

Source: ISO 9001:2016

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

With this information in mind, in the following post I will begin the analysis of Sub-clause 4.1 Understanding the organization and its context.

 

Author:

Ernesto Palomares Hilton