What are ISO, ISO 9001 and Annex SL?
What are ISO, ISO 9001 and Annex SL?
Mark Kaganov, Principal Consultant, Lean ISO Management Systems
ISO is a non-governmental organization established in 1947 in Geneva, Switzerland. Today, ISO has some 160 member countries. The mission of ISO is to promote the development of standardization and related activities in the global marketplace, to simplify the international exchange of goods and services, and to develop cooperation in the spheres of intellectual, scientific, technological, and economic activities.
The term “ISO” stands for the International Organization for Standardization. You may wonder about the difference between the names of the organization: International Organization for Standardization, and the acronym, ISO. Well, the fact is that it is not an acronym. The organization chose the designation “ISO” from the Greek word “isos,” which means “equal.” The prefix iso- occurs in many words, such as isometric, meaning equal measure or dimensions, isonomy, meaning equality of laws or people before the law, and others. From equal to “standard,” the choice of ISO as the name of the organization is easy to follow. The name also has the advantage of being the same in each of the organization’s three official languages — English, French, and Russian. In other words, ISO would not correspond to the official title of the organization in French — Organization Internationale de Normalisation — or Russian — Международная Организация по Стандартизации.
What does this worldwide standardization mean to you and me? Well, thanks to ISO, for example, we can get cash from an automated teller machine (ATM) in New York City, Hong Kong, Buenos Aires, or Moscow. Several ISO standards establish requirements for the format of credit cards, phone cards, and smart cards. These standards define the features of the cards: the size and thickness, the location, and the data format on the magnetic strip. The consistency means that all ATMs, telephones, and other card machines throughout the world can read the cards. Since its establishment, ISO has focused primarily on the development of product-specific standards. However, in the mid-1980s, ISO started its work on systems-related standards. This direction eventually resulted in the well-known ISO 9000 series of standards, ISO 13485 for medical device manufacturers, ISO 14001 for environmental management systems, and others.
The history of standards for modern quality management systems goes back to 1959. That year, the U.S. Department of Defense introduced its MIL-Q-9858 quality management program. For nearly three decades, the U.S. defense and aerospace industries used the standard. In the mid-1960s, the former Soviet Union introduced a national standard KC YKP to govern the quality management process across the country.
In 1979, the British Standards Institution (BSI) had developed and introduced the first commercial quality management system standard for quality that became known as BS 5750. That same year, BSI issued its first certificate to a small cement plant in England for compliance with BS 5750. It took almost another decade for the international community to recognize the benefits of standards for quality management systems.
In 1987, International Organization for Standardization (ISO) finished and introduced to the market its series of ISO 9000 standards. ISO 9001 incorporated a significant part of the elements of BS 5750. The ISO 9000 series of standards first gained popularity in Europe. By the late 1980s, the ISO 9001 standard had reached the U.S. market.
Organizations can use the ISO 9001 standard for any product or service in a wide range of industries. A long time ago, I saw a flag-size poster on a theater in Singapore bragging about its registration to the ISO 9001 certification. A European colleague of mine mentioned that he received an application to register a church choir.
The ISO 9001 standard requires that a company develops and implements a basic quality management system, using the specific elements to ensure the company is capable of maintaining uniformity of its processes and, as a result, provides its customers with a consistent quality of products and services. ISO 9001 comprises a series of standards outlining the requirements and guidelines for quality management systems. There are three core standards in this group:
- ISO 9000 — Quality management systems — Fundamentals and vocabulary
- ISO 9001 — Quality management systems — Requirements
- ISO 9004 — Quality management — Quality of an organization — Guidance to achieve sustained success
ISO has recently, in 2019, renamed its Annex SL standard into Annex L. This standard prescribes the new high-level structure for all ISO management system standards. The document replaces previously used ISO Guide 83. ISO created this standard to define the identical format and common terms and definitions. In the old days, each standard had its structure and enumeration of clauses. When a company used an integrated system, it needed to create cumbersome cross-reference tables to navigate its manuals and documentation structure. Now, with Annex L, every standard shall follow this format:
- Normative References
- Terms and Definitions
- Context of the Organization
- Performance Evaluation
Since the beginning, management system standards focused on the “effectiveness” of the processes, not their “efficiency.” ISO 9001 2015, for example, mentions the term “effectiveness” some seventeen times in its requirements part and “efficiency” only once in the introduction section. We all remember the definitions of these terms, right? Effectiveness is the ability to produce something with the intended results. Efficiency is the ability to accomplish something with the least waste of time and effort. If we made a marker meeting its specifications and the user needs: the process was “effective.” If we made that marker spending $50,000, the process was not “efficient.” Businesses certified to ISO standards have to ensure that their processes are effective. Unfortunately, companies often forget that to succeed in business; one has to be “efficient” also. The application of Lean methods helps companies to make their processes not only effective but also efficient! What is Lean? Check out our Why Lean page.