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E. Palomares Hilton - GESTEC
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On this occasion, I invite you to iniciate the analysis of a topic that is already known, but even when it is very well known at worldwide level, sometimes it seems that each person understands it in their own personal way, even when its elements are common; I am referring to the ISO 9001 standard and what should be a quality management system in compliance with the requirements of this standard.
I will start by commenting that, as you surely are aware, the ISO 9001 standard is a document whose current version is the one published in 2015 by the International Organization for Standardization (ISO), and which is equivalent to the fourth revision of the standard originally approved and published in 1987.
If you analyse the texts of these two standards, the first version and the current one, it could seem to you that they are two completely different standards that deal with different subjects. The focus of the standards themselves, the introductory and referred elements, as well as the identification and description of its requirements differ greatly, even though its orientation and objective do not change as much. The evolution shown by the standard is equivalent to what both people and organizations have increased in these years their knowledge and experience in handling the variety of elements that make up a quality management system, as well as to clarify those specific topics that are usually difficult for them to understand and use correctly, or that at some point they have raised 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 from some previous ones, establishes requirements for a quality management system, aimed at generating trust in its customer, but also in its stakeholders, 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 kind of changing characteristics has led to adjustments over time in practically all the original requirements of this standard, both in the way of identifying and presenting and writing them.
This is a natural process of improving a standard. If every day there are, within the universe of uses of a standard, more knowledge and experience about that standard and its applicability, improvements will be made continuously, not only to keep it current, but also so that the organizations that use it will obtain greater benefits and more learning.
In parallel to this development that ISO 9001 standard has had over time, some methodological support schemes and software products have been developed that are applicable to quality management programs to facilitate compliance with of various requirements of ISO 9001 standard. In my opinion, most of these methodologies and products can generate benefits for the organizations that use them, if those organizations use them appropriately.
However, if you are a professional of quality and have a particular interest in one or more of those methodological schemes and software products applicable to quality management programs, I suggest you to learn how to use them, apply the ones that are beneficial, but I recommend that you do not give up to the importance to both knowledge and a proper understanding of each of the requirements of ISO 9001 standard, as well as to know and comprehend the other elements of this standard, which although they are not requirements, are very important for the proper understanding and application of that standard. I am referring to the introductory and complementary elements of this standard, as well as those of the ISO 9000 standard, which are referenced in ISO 9001 standard itself.
I have already mentioned in a previous post that in order to use a standard appropriately, it is as important to understand both the text of the standard as its context. This is something really important, and generally applies to all standards, including, of course, the ISO 9001. However, it is very common for many professionals in the field of quality management to strive to read and understand the technical elements of the ISO 9001 standard, meaning only its requirements, and they leave aside the context and complementary information of this standard.
Additionally, if we want to start the analysis of the ISO 9001 standard, it is good that we know what the International Organization for Standardization (ISO) presents on its website in relation to the ISO 9001 standard. It begins this presentation with an initial explanation of what are the standards of management systems.
If we take just the information correspondent to the quality management system standards from this website, it tells us that a quality management system is the way an organization manages the interrelated parts of its business to achieve its quality objectives. These objectives may include aspects of the quality of their products or services, as well as the operational efficiency to achieve them.
The level of complexity of the system will depend on each organization’s specific context. 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 from each individual employee and how they contribute to the organization’s overall objectives, without the need for extensive documentation. More complex businesses operating, for example, in highly regulated sectors, may need extensive documentation and controls in order to fulfil their legal obligations and meet their organizational objectives.
And then explains that the standard ISO 9001:2015 specifies requirements for a quality management system when an organization:
a) Needs to demonstrate its ability to
consistently provide products and services that meet customer and applicable
statutory and regulatory requirements, and
b) Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory 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.
With all this information, we will delve into the text of the
introductory elements of the standard ISO 9001:
20015 in the next post.
Author:
Ernesto Palomares Hilton
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