Introduction to the ISO 9001 Standard
Hi, my name is Jared Clark. I am the principal ISO consultant with the Evata Consulting Group.
The purpose of this article is to introduce you to the ISO 9001 standard and the philosophy and principles behind it.
This articles may be used by your entire organization, as everyone will need to understand these principles in order to help create the culture of quality necessary to support your ISO-compliant quality management system.
Where is your ISO 9001 Standard located?
To start out with, make sure you know where your ISO 9001 standard is located, or how to access it, within your organization. Due to copyright restrictions, I cannot display the standard as part of this training. It would be helpful if you could have it available for review during this training.
High-Level-Structure
When you review the table of contents, you will see that the main headings start at 0 and go to 10. It is worth noting that ISO has implemented a new “High Level Structure” that all of its management system standards now follow. That means that ISO 9001, ISO 27001, ISO 14001, ISO 45001, and other management system standards all share these same headings. This makes the integration of the various management systems much simpler. If, for example, an organization wishes to implement ISO 14001 in addition to ISO 9001, the same sections of each standard cover the same topics – the overlap and difference between them can easily be seen if you compare them side-by-side. You’d be surprised to see how much easier it would be to implement ISO 14001 or ISO 45001 once you already have ISO 9001 in place.
That high-level structure is as follows: [Click]
- Introduction
- Scope
- Normative reference
- Terms and definitions
- Context of the organization
- Leadership
- Planning
- Support
- Operation
- Performance Evaluation
- Improvement
Again, this will be the same for all management system standards. Another significate aspect of this new high-level-structure is that it follows the PDCA cycle, which we will discuss later.
Sections of ISO 9001 Explained
Now let’s review these ten sections and place them in context.
The introduction section sets forth the philosophy and principles behind the ISO 9001 standard and provides other insights into the standard, its purpose, and its relationship to other standards.
The scope section simply states that the scope of this standard is to specify requirements for a quality management system.
The Normative Reference section simply references documents that are considered “indispensable” to the application of the standard. In this case, the only document listed is ISO 9000. Often people will mistakenly refer to ISO 9001 as ISO 9000. ISO 9000 is a separate document from ISO 9001 entitled “Quality Management Systems - Fundamentals and Vocabulary” that contains, not surprisingly, definitions for the principles, concepts, and terms used in ISO 9001 and in the other 9000 series standards.
The Terms and Definitions section usually contains terms and definitions for the standard, but in this case ISO 9000 already serves that purpose, so the standard simply refers you to ISO 9000. The downside to this is that you will have to pay extra for ISO 9000.
Sections 4 through 10 contain the substantive requirements of ISO 9001. These sections are covered in great detail in our Understanding ISO 9001 Series of courses, and so these sections will not be discussed in this article.
Introduction Section
This training will focus on the philosophy, principles, and layout of the ISO 9001 standard. This is covered in section 0 of the standard – the Introduction section.
Understanding the philosophy and principles behind the standard is important when it comes to interpreting and applying the standard to your organization. Also when it comes to discussing questions of compliance with your certification auditor. Often the difference between a mediocre implementation of ISO 9001 and an excellent implementation is the degree of understanding that your organization has of these underlying principles and how to apply them.
The introduction section is four pages long and consists of six subsections.
0.1 General
0.2 Quality management principles
0.3.1 Process approach
0.3.2 Plan-Do-Check-Act Cycle
0.3.3 Risk-based thinking
0.4 Relationship with other management system standards
We will hit the main points and provide additional context to enhance your understanding of these concepts and principles.
General Section
Let’s start with the general section. The general section:
- Outlines potential benefits of implementing an ISO-compliant quality management system
- For your information, we cover the benefits of implementing ISO standards in a separate article in our General ISO Education Series.
- Outlines what is contained in subsequent sections of the Introduction
- This is the subject matter of this article, so we will discuss these presently.
- Explains how to interpret the language of the standard
- For your information, we cover how to interpret ISO standards in a separate article in our General ISO Education Series, so we will not discuss this here.
Seven Quality Management Principles
So we can launch right into the quality management principles section.
This section lists 7 quality management principles that provide the foundation for ISO 9001.
- Customer focus (ISO 10001, 10002, 10003, 10004, 10008)
- Leadership (ISO 10014)
- Engagement of people (10015, 10018)
- Process approach (10005, 10006, 10007, 10012, 10013)
- Improvement (ISO 9004)
- Evidence-based decision making (10017, 19011)
- Relationship management
ISO 9000, the “Fundamentals and Vocabulary” document, actually goes through each of these principles in detail and provides a rationale for each principle, the expected benefits of each principle, and the possible actions you could take to integrate the principle into your system. Many of the proposed actions overlap, by the way, with the ISO 9001 requirements. Nonetheless, it is still good to review ISO 9000 in order to deepen your understanding of these principles.
The most overlooked of these principles, in my experience, are the following:
- Leadership, and
- Engagement of people
Studies on the critical success factors of ISO implementation confirm my experience.
The Ten Critical Success Factors
One study identified 10 critical success factors, listed in order of priority – notice the overlap with the Seven Quality Management Principles mentioned in the standard.
- Leadership
- Training
- The involvement of everyone
- Dedicating sufficient organizational resources
- Building a quality‐oriented culture
- Adopting a customer‐based approach
- Adopting a process‐centered approach
- Communication and teamwork
- Customizing the ISO requirements
- Performing adequate quality audits
I think it is interesting that the most difficult parts of implementing ISO are often people-related. I guess at the end of the day a system still needs to be supported by people – people who understand the system, appreciate the system for what it does, and maintain the system with an expectation of valuable results.
Evata strives to go the extra mile to provide you with additional methods and tools to address each of these critical success factors, especially those top three most critical success factors: leadership, training, and the involvement of everyone. Hopefully careful attention to these factors will help to ensure the success of your implementation system.
The Process Approach
Now on to the Process Approach Section. The process approach is about understanding and managing your processes in a way that enhances performance and ensures continual improvement.
This section provides this schematic representing the elements of a single process.
Understanding single processes is the first step.
The elements listed here are:
- Sources of inputs
- Inputs
- Activities
- Outputs
- Receivers of Outputs, and
- Controls and checkpoints to monitor and measure performance
With respect to every controlled process, you should define these elements and identify how those elements interact with other processes.