by Denise Robitaille
By now most people are aware that ISO 9001 is in the process of being revised, with a planned release date of sometime in 2015. Reactions from users to the impending release of ISO 9001:2015 range from mild curiosity to excitement to extreme trepidation.
ISO 9001 hasn’t had a significant makeover since 2000, and a lot has changed in our world since then. Supply chains now routinely span the globe. Vast quantities of information can be transmitted virtually instantaneously. Environmental concerns are now incorporated into most organizations’ strategic plans. The evolution of ideas and technology has exploded—and our ability to manage it all has become increasingly critical. It is in this tumultuous environment that the most popular standard ever published by the International Organization for Standardization (ISO) is being revised.
More than three years ago, anticipating the eventuality of a revision, members of ISO Subcommittee 2 (SC 2)—the subcommittee responsible for the revision and maintenance of ISO 9001—began conducting an extensive user survey. It was important to solicit the kind of information the market could provide to ensure that ISO 9001 remained relevant and beneficial to the users.
Feedback was sought from every industry and sector, from users of other management system standards, and even from those who have chosen not to implement an ISO 9001-compliant quality management system (QMS). More than 10,000 responses were received from around the world. Many contained comments that needed to be translated. All these data were collated, reviewed, and analyzed.
Overall, the consensus from respondents was that the standard is good as it is, but it needs to be revised. There seemed to be little support for wholesale changes or creating a hierarchical or tiered set of requirements standards similar to Capability Maturity Model Integration (CMMI)—a framework for improving the processes organizations use to develop, deliver, and maintain products and services, initially utilized in the software industry but gaining acceptance in other fields—or the old ISO 9001/ISO 9002/ISO 9003 scheme. There is also little support for withdrawing ISO 9001.
ISO 9001 user survey’s most common comments
The most commonly received comments from the extensive survey that SC 2 sent to ISO users related to the following:
- Requests to include requirements relating to risk management, financial management, and change management
- Requests for clarification of existing requirements relating to outsourcing, product realization, and the distinction between verification and validation
- Some respondents voiced concern about the ease of use for service and software industries
Concepts and ideas for the ISO 9001:2015 revision
While the user survey was being conducted, a task group was established to explore “concepts and ideas for a future revision of ISO 9001.” During the course of several meetings, the technical experts explored the significant global changes and evolving concepts vis-à-vis the standard to decide which ones might be relevant to any future revisions. Some of the concepts that were discussed included:
- Risk management approach
- Financial resources of the organization
- Time, speed, agility
- Process management
- Knowledge management
- Maintenance of infrastructure
- Product and service life-cycle management
- Supply chain management (and outsourcing)
- Expanding the concept of customer
This list represents only a small subset of the original plethora of ideas that were advanced.
It should be noted that inclusion on this list, in the survey results, or in any other document does not guarantee that the concept will find its way into the newly revised standard. Although it’s likely some of the ideas will be incorporated, many others will continue to be perceived as outside of the scope of ISO 9001. It’s important to remember that ISO 9001 is a generic requirements document and that the requirements must be applicable to the broad and diverse spectrum of users. It is not a “how to” guide nor is it an encyclopedia of tools.
Based on the work of the task group, several white papers were generated elaborating the justification for possible inclusion of some of the concepts.
In accordance with ISO directives, the members of ISO Technical Committee (TC) 176 initiated a systematic review of ISO 9001 in October 2011. The ballot choices for a systematic review are: withdraw, revise/amend, or confirm. The output of the global survey and of the task group meetings provided essential feedback to the participating members as they cast their votes. When the ballot closed in March 2012, the results were announced. The members of TC 176 had voted to revise/amend.
Having made the decision to revise ISO 9001, SC 2 began laying the foundation for the work ahead. This kind of revision project generally takes several years. A working group (WG 24) was established, requests went out to nominate experts to participate, and the new work item proposal was developed.
In subsequent meetings the task group moved forward with a project plan, design specification, and working draft. Inputs into the design review process included the results of customer surveys, white papers generated from the task group on the future of ISO 9001, and ideas tabled during the previous revision that had been deemed inappropriate for a minor revision.
There are two other factors that are having an influence on the revision. The first is the impending revision to the Quality Management Principles. This fundamental document lays the foundation for any quality management system and can be found in the document above as well as in ISO 9000:2005 and ISO 9004:2009. The principles relate to, among other things, leadership, the customer, involvement of people, and the process approach. The principles have remained unchanged for more than two decades. Although this revision will not be dramatic, it is important. It may result in a slight shift in focus for organizations implementing quality management systems.
The second factor is the development of a high-level structure by the Joint Technical Coordination Group for all ISO management system standards. The structure has been published in the ISO directives and is known as Annex SL. Although the intent is to bring greater homogeneity to the systems of organizations that adopt multiple management system standards, it remains to be determined what effect it will have on the revision of ISO 9001.
In the coming months, the output of the most recent meeting of the WG 24 will be released. The committee draft (CD) of ISO 9001:2015 is expected to be for sale sometime in June. At that time, comments will be solicited to ensure that this revision perpetuates the high standard that has been the hallmark of ISO 9001 for more than a quarter of a century.
About the author
Denise Robitaille is a member of the U.S. TAG to ISO/TC 176, the committee responsible for updating the ISO 9000 family of standards. She is committed to making your quality system meaningful. Through training, Robitaille helps you turn audits, corrective actions, management reviews, and processes of implementing ISO 9001 into value-added features of your company. She’s an Exemplar Global-certified lead assessor, ASQ-certified quality auditor, and ASQ Fellow. She’s the author of numerous articles and several books, including The Corrective Action Handbook, The Preventive Action Handbook, and her latest book, 9 Keys to Successful Audits, all published by Paton Professional.
This article originally appeared in Quality Digest Daily, an electronic publication from Quality Digest (www.qualitydigest.com).