What’s Old Is New Again
ISO 9001 revision planning is under way
by John E. "Jack" West, Lorri Hunt, Nigel H. Croft and Alka JarvisThe time appears to have finally come to start another major revision of ISO 9001. But before moving forward, it’s a good idea to look back at where we’ve been. So let’s place this work in a historical perspective.
This year marks the 25th anniversary of the first edition of ISO 9001, which debuted in 1987. But the work on international standards for quality management started in 1980 with the establishment of ISO Technical Committee 176 (ISO/TC 176). The committee’s initial work was to establish an agreed-on vocabulary for quality management. This required several years of detailed discussions among quality leaders around the world.
Richard Freund—a former president of ASQ for whom the ASQ Freund-Marquardt Medal is, in part, named—was instrumental in getting much of the terminology found in ASQ literature imbedded in the international vocabulary.
ISO/TC 176 issued its first standard, ISO 8402, in 1986. The standard presented the terminology developed by Subcommittee 1 in 1986. The first version of ISO 9001—along with two other lower-level standards, ISO 9002:1987 and ISO 9003:1987—was issued by Subcommittee 2 in 1987.
These releases were based on traditional 20-element quality assurance models that had been used for many years in industries such as nuclear, defense and manufacturing.
Figure 1Phasing it in
Early in the process, it was recognized that ISO 9001:1987 could be substantially improved, so a two-phase revision process was set in place in 1990 to develop a near-term minor revision followed by a more substantial improvement.ISO 9001:1994 included changes to significantly improve the clause on control of design and development, and to provide several other clarifications. The 1994 series also slightly modified the role of ISO 9002 and 9003.
In the second stage of this revision process, the major changes were to the format of the standard, the elimination of ISO 9002 and 9003, and a focus on process management—called the process approach. A clause on application also was added to the scope to allow for the exclusion of specific requirements that were not relevant to the organization and to accommodate the elimination of ISO 9002 and 9003.
The ISO 9001:2008 revision can be thought of as an amendment to clarify issues that had been raised during the application of ISO 9001:2000. It included several changes to the text but no additional requirements.
This decision was based on the fact that ISO 9001:2000 had allowed for a three-year transition period, so many organizations were only just coming to grips with the new concepts—in particular the process approach—and user feedback indicated a period of stability was needed prior to significant changes.
Furthermore, sector-specific standards based on ISO 9001, such as ISO/TS 16949 in the automotive industry, had completed their revision cycle later. To introduce major new changes would have caused significant disruptions and added costs in the supply chain.
Having their say
The International Organization for Standardization (ISO) initiated the normal three-year systematic review of ISO 9001:2008 three years after it was published. A systematic review involves a ballot of the participating national member bodies of ISO/TC 176 Subcommittee 2 in which the voting options are:- Confirm—continue with the document as is.
- Revise/amend—make changes.
- Withdraw—eliminate the document.
There are many inputs to the revision process. The ISO Technical Management Board has adopted a standardized format and common-core text for use in all new and revised ISO management system standards. This promotes greater ease of use for organizations that want to integrate the requirements of standards such as ISO 9001, ISO 14001 and ISO 50001 into a single, coherent system.
In the early stages of the systematic review, the chair of Subcommittee 2 sent a comprehensive letter of explanation to ensure the members understood the context in which the review was being conducted. For example, it’s obvious a vote to revise would subject the revision to the new format and standardized text requirements.
It was also clear to many that failure to propose a new version could be fatal to the ultimate use of ISO 9001. After all, by the time a new revision could be issued, the standard would have been almost unchanged for 15 years. Table 1 compares the titles of the clauses from ISO 9001:2008 and the common structure.
Table 1Background info
The next revision will consider as inputs work that has been completed since ISO 9001:2008 was published. This background work was planned specifically to support any potential revision to ISO 9001 or its associated standards, including the following:Survey results. An extensive web-based user survey was conducted to obtain feedback from users and non-users of ISO 9001. This survey was unique in that it focused on feedback about concepts rather than specific clauses to change.
In particular, it included information on the concepts that were explored for consideration of future work in Subcommittee 2. It also sought information from non-users on what types of things would encourage the use of ISO 9001 in their organizations.
Results of studies of the latest thinking on quality management. At the time ISO 9001:2008 was published, many suggestions for improvement were provided. But due to the nature of an amendment and the mandate for no new requirements, these suggestions could not be incorporated at that time.
These ideas were published in a report from the task group that developed ISO 9001:2008. The ideas were subsequently merged into concepts to be considered in any future work of Subcommittee 2, but specifically work related to ISO 9001. White papers were developed exploring the benefits of incorporating the concept and the potential impact to users.
Review of quality management principles. Prior to ISO 9001:2000, quality management principles were developed by a group of strategic thinkers within Subcommittee 2 as the foundation for its quality management standards. These principles were not reviewed at the time ISO 9001:2008 was published, but due to the nature of the changing world, it was decided they should be reviewed to ensure their ongoing relevance prior to any future revision to ISO 9001.
To do this work, a joint task group comprised of representatives of Subcommittees 1 and 2 was established. This work will probably be completed in mid-2012—in time to provide an input to the revision of ISO 9001:2008. The outputs of that group also will form inputs into the future revision of the quality fundamentals section of ISO 9000.
Experience with the current and past editions. When ISO 9001:2000 was published, a group was established to review requests for interpretations of specific issues related to the standard. Many of the needed clarifications were incorporated into ISO 9001:2008. But because ISO 9001:2008 could not include new requirements or delete existing ones, some needed improvements could not be made.
There have been subsequent requests for interpretation of ISO 9001:2008, but these will be considered during the next revision process.
Subcommittee 2’s vision, mission and strategic plan. These were developed in 2010-2011 to provide long-term direction to the subcommittee’s work. These and associated white papers establish the relationship between ISO 9001 and ISO 9004, and the role of the other documents and tools that support their correct interpretation and implementation.
All of this helps achieve Subcommittee 2’s core mission: to develop, maintain and support a portfolio of products that enable organizations to improve their performance and to benefit from the implementation of a robust quality management system.
Likely revision process
Figure 2 shows the revision process. The details may change over time, but the steps will most likely look like this:
Figure 2Development. After the NWIP is approved, WG24 will develop the revised drafts of the new version. There may be one or more working drafts provided to the member bodies for comment and to develop initial consensus on the technical detail.
Committee draft (CD). After WG24 has achieved an initial level of consensus, it will prepare a CD that is formally balloted by the Subcommittee 2 member bodies. At this stage, the technical content should be generally agreed on, although detailed wording may not be perfected. Also at this stage, WG24 will probably start a verification and validation process to ensure the initial specifications in the NWIP have been met and that the draft meets users’ needs.
Draft international standard (DIS). After the CD is approved for circulation as a DIS, it will be submitted for a formal ballot of the Subcommittee 2 participating members by ISO’s Central Secretariat in Geneva.
Final draft international standard. After the DIS has been approved, the standard would move to the publication stage. The document will be finalized by the staff in Geneva and submitted for final ballot to the Subcommittee 2 participating members. This stage is generally considered to be a simple check for editing errors, and only minor changes can be made.
International standard. After approval of the FDIS, the document will be published and provided to member bodies for national adoption purposes. In the United States, ASQ adopts these standards as American national standards as a part of the American National Standards Institute national adoption process.
Get involved
With so much work ahead, the U.S. Technical Advisory Group (TAG) to ISO/TC 176 is seeking qualified people to help with standards work.TAG members review documents and provide input on national positions for documents such as ISO 9001. They provide input to the delegates who represent the TAG at international meetings. If you are interested in volunteering for this work, call ASQ headquarters 800-248-1946, and ask for the standards staff.
John E. "Jack" West is past chair of the U.S. Technical Advisory Group for the International Organization for Standardization Technical Committee 176 (ISO/TC 176) and a current member of the ISO/TC 176 Subcommittee 2 Strategic Planning and Operations Task Group.
Lorri Hunt is the U.S. lead delegate to ISO/TC 176 Subcommittee 2.
Nigel H. Croft is chair of ISO/TC 176 Subcommittee 2.
Alka Jarvis is the current chair of the U.S. Technical Advisory Group for ISO/TC 176 and a current member of the ISO/TC 176 Subcommittee 2 Strategic Planning and Operations Task Group.
No comments:
Post a Comment