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E. Palomares Hilton - GESTEC
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This time I will continue analysing the context of the ISO 9001: 2015 standard, and I will do so with the Clause Introduction.
I invite you, dear reader, both in this post and in the following, to enter into an analysis, within the context of the ISO 9001: 2015 standard, with the clause that is identified with the number 0, or not numbered at all, so it is not part of the content “certifiable” of this standard, no organization has to demonstrate compliance in a certification process, but that contains information that if we do not know and understand properly, it would be highly unlikely that we could establish a valuable quality management system , in compliance with the aforementioned standard. I am referring to the Introduction clause.
In previous entries on this blog, I have commented that at least in Mexico, most of the people who carry out their daily work in relation to one or more clauses of the ISO 9001 standard, including consultants and auditors of quality management systems, they only read and try to understand the clause or clauses of this standard that contain the requirements that are of their interest, and from this, few people pay attention to the introductory, referenced or complementary elements of said standard, which are the that I mentioned that make up the context of the standard. I have already presented to you the information with which ISO makes the presentation of this standard as well as others from different management systems on its website, and later we started this analysis of the context of ISO 9001:2015 with the presentation of the Foreword of this standard.
As I have mentioned in another post, when it is considered relevant to establish 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. We then begin with the analysis of clause 0 of ISO 9001: Introduction.
Due to the large amount of information that has been considered should be placed in this clause, 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 texts 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 the information in a standard that we commonly find it difficult to fully understand what some requirement establishes. Therefore, we must carefully read and understand what a standard establishes in each of its requirements. That is why there are organizations that offer courses in interpreting the 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 the establishment, operation or improvement of 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 the requirements:
The 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.
The 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.
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:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
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 standard. 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 ISO 9000: 2015 standard you will find a better description of these principles, and I hope you can analyse them in depth, but I include here the basic statement of each principle. Each of them, in addition to this statement, presents 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 success, organizations manage their relationships with relevant stakeholders, such as suppliers.
(This topic continues in the next post: ISO 9001: 2015 Introductory
Elements (Part 3).
Author:
Ernesto Palomares Hilton
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