The International Organization for Standardization (ISO) is at work on a major revision to its standard ISO 9001; an internationally-recognized standard that outlines the principles for quality management systems. The revision, the first major rewrite since 2000 (a 2008 update included no changes to the technical requirements), is currently scheduled for publication in September 2015, and is expected to include a number of important changes for organizations currently holding ISO 9001 certification, as well as those contemplating the development and implementation of a quality management system. This page will provide answers to many of the frequently asked questions about the upcoming revision of ISO 9001.
Why is a revision of ISO 9001 being undertaken?
Originally developed and published in 1987, ISO 9001 was based on the quality management principles originally identified by Dr. W. Edwards Deming, Dr. Joseph M. Duran and other leading quality management system quality professionals. Since then, ISO 9001 has served as the foundation for many other sector specific management system standards, such as ISO 13485 (medical), AS 9100 (aerospace & defense), TS 16949 (automotive) and TL 9000 (telecommunications).
In recent years, the ISO Technical Committee 176 (TC 176), the committee responsible for ISO 9001, determined that a fundamental review of the standard and its underlying quality management principles was required. That review found that the standard was in active, widespread use, and had withstood the test of time well. At the same time, the review also noted that the essential principles that served as the basis for ISO 9001 had undergone considerable evolution during the 25-years since the standard’s original publication, and that the standard needed to evolve to remain relevant to modern quality management practices.
What are the goals of the ISO 9001 revision?
ISO/TC 176 has articulated a number of goals that it hopes to achieve in this revision of ISO 9001.
Establishing a stable core set of requirements suitable for the next 10 years and beyond
Ensure that the standard remains relevant to organizations in any industry sector of all types and sizes
Maintain the standard’s current focus on effective process management as the primary tool to produce desired quality outcomes
Account for changes in quality management systems practices and technology since the last major revision of the standard in 2000
Reflect on the requirements of the increasingly complex, demanding and dynamic environments in which organizations operate
Facilitate efficient and effective implementation of quality management systems, and streamline the conformity assessment process
Utilize simplified language to aid in the understanding of the standard and establish consistent interpretations of the standard’s requirements
Apply to the standard the framework detailed in Annex SL of ISO Directives to enhance compatibility and alignment with other ISO management systems standards.
What advanced research and planning did the ISO/TC 176 conduct for this revision?
From the beginning, ISO/TC 176 realized that it needed to develop a long-term strategic plan for ISO 9001. Committee members began the planning process by hosting several open workshops with current users of ISO 9001. ISO/ TC 176 also launched a web-based survey of users and potential users of the standard in 10 different languages, and received nearly 12,000 responses from users in more than 120 countries.
In addition, ISO/TC 176 studied the latest concepts and trends in quality management that might be incorporated into future revisions. Finally, ISO/TC 176 worked with other ISO Technical Committees to develop a high-level structure, definition set and common content that could be used across all management system standards. The result of this joint committee work has now been published as Annex SL to the ISO Directives.
What is the current status of the revision?
Actual deliberations have progressed at a slightly different pace compared to the original proposed timeline for the development and publication of the revised ISO 9001. For example, the Committee Draft of the revised standard, ISO/CD 9001, was actually issued in June 2013, two months later than the original schedule. As a result, balloting on the Draft International Standard (DIS) began in April 2014 and will continue through August 2014.
Currently, ISO/TC 176 projects that the newly revised ISO 9001 will be published in September 2015. However, achieving this deadline depends in part on the outcomes of the DIS and Final Draft International Standard (FDIS) balloting.
Regardless of the actual publication date, it is expected that organizations will be provided with a three-year window within which to modify their previously certified quality management systems to meet the requirements of the newly revised standard.
What are some of the anticipated changes in the new version of ISO 9001?
The ISO 9001 revision is expected to include a number of important changes, including the following modifications:
The revised standard will adopt the high-level structure presented in Annex SL to the ISO Directives, as well as terms, definitions and content similar to other management systems standards. It is anticipated that approximately 30% the content of all future management systems standards will be identical.
The standard’s current focus on process management will be strengthened, with a greater emphasis on producing desired outputs, and demonstrated confidence in an organization’s ability to consistently produce that output.
The revision will employ more simplified language to ease the process of translating the standard into multiple languages, and to help ensure consistent application of its requirements.
The revised standard will place an increased emphasis on risk management and business management throughout its scope.
The standard will include less explicit requirements for documented procedures, but more explicit requirements on documented information.
The revision will modify the use of a number of terms, as follows:
Use of the terms "goods and services" instead of "product"
An emphasis on "improvement’ rather than "continual improvement," reflecting common practice
The terms "purchasing" and "outsourcing" will be replaced with "external provision of goods and services."
How will organizations currently holding ISO 9001 certification be affected by the standard's changes?
Until the revised standard’s projected publication date of September 2015, organizations currently holding ISO 9001 certification should track the progress of the revision process as well as information regarding important changes to the standard. Organizations may also want to consider beginning the process of reviewing their existing quality management system for possible areas of change under the new requirements. Once the revised standard has been published, certified organizations will need to carefully review changes in the standard and map out a process for implementing modifications to their existing quality management system to meet the new requirements.
Should organizations considering ISO 9001 certification delay until the new version of the standard has been released?
Implementing an effective quality management system and achieving ISO 9001 certification is an important step in an organization’s commitment to quality, and the benefits will typically out weigh any challenges associated with the introduction of revised requirements. However, given the amount of time usually necessary for implementation and certification, organizations beginning that process now may want to consider the prospective changes in the standard as they develop their quality management plan.