What is ISO 9001? Introduction to ISO 9001

Learn How the International Organization for Standardization’s Premiere Quality Management System Standard Can Help Your Organization

At the heart of all good organizations is the relentless pursuit and maintenance of quality. This focus on quality is key, regardless of whether the organization is a company, non-profit, or a branch of a government. To create this culture of quality and keep it strong over time, many organizations have employed the concept of a quality management system (QMS). A QMS is a set of rules and guidelines that an organization can follow to maintain quality, and each organization must create their own QMS, following a standard that can guide its development and implementation. Among the world’s finest QMS standards, there is none more prevalent and influential than ISO 9001. Created and promulgated by the International Organization for Standardization (ISO), the ISO 9001 QMS standard has been utilized by over 1.2 million companies, organizations, and governments around the world. Yet, if your organization is new to the concept of quality management, this venerable standard may seem unfamiliar and even intimidating. This introductory article provides an overview of what ISO 9001 is, how it can be used to help you create a QMS, and how assistive tools like our product QMS2GO can be utilized to help you learn and make sense of ISO 9001’s complexities. This article also serves as the first in a series of ISO 9001-related articles which cover the standard in great detail; we encourage you to start here, and then check out all the other articles to fully understand the utility and value of this world-renowned QMS standard.

Introduction to ISO 9001

Throughout our many blog articles and informational resources at QMS2GO, we’ve frequently talked about quality management system (QMS) standards. These standards are the guidance documents that allow an organization, whether a company, non-profit, or government, to design, implement, and maintain a QMS. And among global standards, there is none more significant or influential than ISO 9001. This preeminent standard, in continuous publication since 1987, serves as the underpinnings for quality management systems utilized by over 1.2 million organizations worldwide, making it by far the most widely-used QMS standard.[1] The great versatility of ISO 9001 lies in its continuous evolution to match changing times and needs, as well as its generality in providing useful guidance for a wide range of organizational types. Unlike some QMS standards which are industry-specific and issued / audited by trade organizations, ISO 9001 is not officially enforced; indeed, it is not even a system in and of itself. Rather, it is a set of guidelines, an instruction book, if you will, for how a QMS can be created. Compliance with ISO 9001 is determined by having an organization submit to optional audits by qualified and accredited third-party entities. These are typically consultancies that have trained staff who specialize in the latest revisions and additions to the ISO 9001 standard. While being audited is voluntary, many organizations eagerly seek such certification from an accredited third party so as to demonstrate their compliance and competency in following the standard.

The aforementioned versatility of ISO 9001 has also enabled it to be either the basis for, or a companion to, many of the other industry-specific standards. For example, AS9001 Revision D, the standard of choice for the aircraft and spacecraft industries, is derived from ISO 9001 and differs primarily by incorporating several additional safety assurance and risk avoidance sections which are applicable to aerospace.[2][3] Several other industry standards, while written as their own unique guidelines, are still regularly adjusted to operate in conformance with ISO 9001. This enables organizations which follow these conformed industry-specific standards to also comply with, and achieve certification for, ISO 9001. Being covered by two widely-recognized standards can carry great benefits for companies which need to establish and prioritize vendor and customer trust. Furthermore, this overlap with ISO 9001 allows companies in highly-specialized industries to also vouch for their quality management when dealing with clients

outside their specific field.

If an organization is looking to create a QMS for the first time, in nearly all instances, the standard to turn to will be ISO 9001. But who has created and maintained this standard, and how do they ensure that ISO 9001 remains applicable to a vast range of potential needs? To answer that question, we must consider the author of ISO 9001: the influential and important ISO.

Throughout the world, innumerable processes occur in government, business, and other organizations, every single day. To one extent or another, all of these activities depend upon set understandings of basic facts and accurate data. These understandings are standards. Merriam-Webster defines a ‘standard’ as “something established by authority, custom, or general consent as a model or example,”[1] and the same dictionary defines the related concept of ‘standardization’ as “to bring into conformity with a standard especially in order to assure consistency and regularity.”[2] Because we take standards for granted, we may not realize that they themselves must be created and promulgated. Therefore, the natural question arising from this realization is: who is creating the world’s standards?

The answer to this question is the International Organization for Standardization, commonly known as the ISO. This little known but vastly important organization has, since 1947, written and issued the standards which govern our understanding of the modern world. Based in Switzerland and comprised of global experts in multitudinous fields, the ISO designates such things as country codes,[3] the internationally-recognized measurements of date and time,[4] and the precise way that computer data can be recorded onto storage media.[5] There is no facet of our lives that the ISO’s guidance has not somehow touched. Simply put, it is the most important organization you have probably never heard of.

The roots of the ISO date back to 1926 and the predecessor organization known as the International Federation of the National Standardizing Associations (ISA). This prior organization focused on standardization of practices in the field of mechanical engineering, and was a trailblazer in bringing together the previously disconnected and uncooperative standardizing bodies of various countries in Western Europe. Unfortunately, the advent of World War II brought an end to the ISA in 1942; at that time, it was hard to focus on maintaining any kind of standardization when the entire globe was in desperate conflict.[6] Nonetheless, the scientists, engineers, and statisticians who had made up the ISA knew that, when peace returned, so too must a new embodiment of their group. Meanwhile, in 1944, with the war still raging, the Allied countries brought together their own standardization group to aid the war effort and lay the groundwork for eventual reconstruction. The name of this group, perhaps prophetically of what was to come, was the United Nations Standards Coordinating Committee (UNSCC); the group predated the actual United Nations by nearly a year. Once the war had ended, the UNSCC called upon the ISA’s members to unify with them and create a new, successor organization: the ISO.[7] In 1946, 65 delegates from 25 countries met to begin this vital work. And finally, in 1947, the ISO was officially established. With the goal that all their standards would provide consistent understanding and application, and perhaps with a wish to reunify the still broken and grieving world, the ISO chose its acronym to invoke the Greek word “isos” – meaning that ‘all are

equal.’[8]

In the postwar decades, the ISO worked to ensure that, regardless of politics and governance issues, all interested global parties would be involved in and abide by the standardization initiatives the organization established. Even in the depths of the Cold War, the Western and Eastern Blocs both participated in creating ISO standards. And since the end of the Cold War, the ISO’s influence has extended to nearly every country in the world. Today, 172 countries and territories are ISO members,[9] and over 25,000 standards have been created and are regularly updated and overseen by 840 technical committees and subcommittees.[8] From humble beginnings to global prominence, the ISO is now one of the most influential and respected organizations on Earth. It should therefore come as no surprise that, when they create or update a standard, the world takes notice.