What is ISO 9001 and why is a revision 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 9001:2015 revision?
ISO/TC 176 has articulated a number of goals that it hopes to achieve in this revision of ISO 9001.
The goals include:
Establishing a stable core set of requirements suitable for the next 10 years and beyond Making sure that the standard remains relevant to organizations of all types and sizes and operating in any industry sector
Maintaining the standard’s current focus on effective process management as the primary tool to produce desired quality outcomes
Accounting for changes in quality management systems practices and technology since the last major revision of the standard in 2000
Reflecting the requirements of the increasingly complex, demanding and dynamic environments in which organizations operate
Facilitating efficient and effective implementation of quality management systems, and streamlining the conformity assessment process
Using simplified language to aid in understanding and consistent interpretations of the standard’s requirements
Finally, applying 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. So 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?
ISO 9001:2015 was published on 23 September 2015. Organizations have a three year window to modify their previously certified quality management systems to meet the requirements of the newly revised standard.
How will organizations currently holding ISO 9001 certification be affected by the changes in the new version of the standard?
Organizations have a three year window to modify their previously certified quality management systems to meet the requirements of the newly revised standard. TÜV SÜD recommends that organizations upgrade their systems to the new standard at an early stage within the scope of a regular re-certification audit.