Tom Taormina Those who are invested in Quality Management System implementation and operation may find that understanding its genesis can greatly enhance their ability to be more effective facilitators – especially given that some of you were born after the first version was released in 1987. In this article, you will learn about the forerunner and history of ISO 9000 quality standards and the most important from the series – ISO 9001, which is one of the most widely accepted Quality Management System standards in current use.
Beginning of the quality standardization
World War II devastated most of Europe. Winston Churchill first proposed the concept of a “United States of Europe” in 1946. As treaties evolved and countries rebuilt, they found that there were many aspects of businesses that were incompatible from country to country. Quality standards were very diverse, and the need for a single standard led to the creation of what we now know as ISO 9001.
The quality founding fathers contracted with the International Organization for Standardization to create a non-binding quality standard. ISO, as it is now known, is in the business of writing such standards. Those who remember film cameras know that ISO 100 and ISO 200 are standards for film stock.
Technical Committee 176 (ISO/TC 176) was formed in 1979 to create a universal quality standard. Based on the British Standard BS5750, ISO 9000 was first released in 1987. It was referred to as a “quality assurance standard,” with ISO 9000 being the guidance document. The actual certification standards were divided into three parts:
- ISO 9001 was for organizations that conducted design, production and servicing.
- ISO 9002 was the standard for production and servicing companies that did not do design.
- ISO 9003 was applicable to organizations that neither designed nor produced products, such as those engaged in testing and distribution.
And they saw it was good
Those of us who were burdened by inflexible military quality standards, such as MIL-Q-9858 and MIL-I-45208, saw the standard as a revolutionary new tool from which to base quality systems that specifically fit their organizational structure and needs. Early adopters created the motto “Write down what you do, do what you write down, and make sure you are doing it” as the easily understood essence of the standard.
“Write down what you do” refers to documenting the processes and their interactions within your organization. “Do what you write down” describes the actions you take to realize your products and services and ensure that they yield the desired outcomes. “Make sure you are doing it” refers to what we know today as QMS auditing. That is, on an ongoing basis, conducting proactive audits to ensure that the processes are effective for their intended use and verify the operator’s ongoing competence.
But how do we certify conformance to the standard?
If the standard was initially intended to be applied universally throughout Europe, what mechanism was necessary to ensure that organizations were actually compliant with it? The governmental bodies that controlled their version/translation of the standard certainly did not want to take on a policing function. That led to the evolution of certification organizations.
Early on, agencies such as the American Bureau of Shipping (ABS) and Det Norske Veritas (DNV) added ISO 9000 certification services to their core businesses of certifying sailing vessels. The national accreditation bodies created a credentialing system for the certification companies to audit and grant certificates of conformance to individual organizations that demonstrated compliance with the standard.
From that beginning, the processes of desk audit, initial certification, periodic surveillance audits, three-year recertification and transition certification evolved into the current formal conformance process.
If you build it, they will come
During the 1990s, ISO 9000 exploded in its adoption and implementation. Because of its universal acceptance, consulting firms and certification services proliferated. Then, entire industries adopted the standard as a basic credential for becoming an approved supplier.
The petrochemical industry was an early adopter, and Houston, Texas, became the epicenter of ISO 9000 implementation. I facilitated ISO 9001 and ISO 9002 implementations across Texas, trained internal auditors, and wrote three guidance books for ABS Government Institutes, the consulting arm of ABS QE, the certification body.
The American Society for Quality (ASQ) devoted extensive resources to helping organizations with standards implementation and training. I chaired the Quality Management Systems Committee of ASQ and helped develop the foundation for the body of knowledge for the current ASQ certifications, such as CMQ/OE and CQA.
The essence of continual improvement
Along with the widespread implementation of the standard, professional organizations blossomed, and entire conferences were convened on the topic of quality management. TC 176 gathered vast amounts of data on implementation techniques and auditing practices. They also found that the 1987 standard was developing controversy and confusion as it was implemented in a wide variety of countries, industries, and organizations.
There was also strife about the early adopters interpreting “write down what you do” as documenting everything in the organization. As a result, many organizations became paper mills of manuals, procedures, and forms.
TC 176 did have a plan for revising the standard approximately every five years, but the amount of data to be studied and the differing opinions on interpretations and acceptance criteria became overwhelming. I sat in on one session where the entire debate was over the meaning of “continuous” and “continual” as they relate to the standard. It seems that neither word translates well into German or French.
Revision through the years
The outcome of the TC 176 continual improvement process led to the following revisions:
1994. The first revision emphasized preventive action and made a first attempt at slowing down the documentation paper mill.
2000. The second revision was a complete rewrite and did away with the three separate standards. It focused on process management instead of reactive quality assurance and quality control. It placed a higher burden on senior management to integrate quality management into business management.
2008. This revision introduced clarifications from the ongoing work of TC 176 and began harmonization with ISO 14001:2004.
2015. Another complete rewrite of the standard, this version introduced a new era of Quality Management Systems. It suggested replacing preventive action with risk-based thinking. Further, it created a focus on business performance instead of quality metrics and greatly streamlined the required documentation.
To learn more about the latest ISO 9001 revision, check out this Infographic: ISO 9001:2015 vs. 2008 revision – What has changed?
The future of the ISO 9001 standard
There are varying statistics, but there were more than 1.3 million ISO 9001 certificates in effect at the end of 2014 in 190+ countries around the globe.
Having a better understanding of the history, perhaps some of you will contribute evolutionary input to the 2020 revision.
Each revision of ISO 9001 has focused more on the success of the organization, rather than on the tools of quality management. The more we can contribute to business success, the more valuable will be the contribution of Quality Management Systems.
To comply with all ISO 9001 requirements, use this helpful ISO 9001 Premium Documentation Toolkit that provides all QMS documents.
