Is It Already That Time—Again?
by John E. “Jack” West
For most organizations, the transition to ISO 9001:2000 is a recent memory. The transition period just ended last December.
Yet, on Dec. 18, 2003, just three days after the transition period ended, the committee responsible for the standard issued a call for systematic review of ISO 9001:2000 and ISO 9004:2000. What is going on here? Are we going to start revising ISO 9001 again this soon?
Much to my relief and I am certain yours too, the simple answer is no. In fact, the working group (WG) responsible for ISO 9001 (WG 18) has indicated the earliest that any revision or amendment could be issued would be the second quarter of 2008. But it is time to start the process of getting formal feedback on the 2000 standards from all around the world.
You may be aware that ISO technical committee (TC) 176 has been soliciting feedback from organizations that implement ISO 9001:2000 through its Product Support Initiative. But the number of organizations that have made submissions has been small.
You may have noticed the an-nouncement in the news pages of the March issue of Quality Progress asking for feedback on both ISO 9001:2000 and ISO 9004:2000 at TC 176’s website, http://isotc.iso.ch/webquest/tc176/index.html.
Jeffrey Hooper, leader of WG 18, points out this survey breaks new ground for the International Organi-zation for Standardization, known as ISO. He said, “I would emphasize that this online ISO 9001 and ISO 9004 survey is another first for ISO—the first time a Web survey has been used worldwide to gather feedback on the use of a major standard with the opportunity to provide specific suggestions for improvement.”
Your feedback is important, so please go to the site and provide it. But the public survey is only a part of a much more complex process to determine what, if any, changes are to be made. ISO Guide 72 requires completion of a market justification study before any change can be made to any ISO management system standard, and even before that there will be systematic review by the committee members.
Exact details on how the market justification study will be produced are being worked out now, but the study should be available to TC 176 members sometime prior to its November 2004 meeting.
Figure 1 illustrates the activities and projected approximate timing required to get to a decision to revise or amend ISO 9001:2000 and ISO 9004:2000. It is quite likely the decision will be different for ISO 9001 than for ISO 9004.
Possible Scenario for ISO 9001
There is a valid argument the requirements of ISO 9001:2000 should remain stable for quite a while.
In fact, some leaders in industries with sector specific documents (such as AS 9100 for aerospace, TS 16949 for automotive and TL 9000 for telecommunications) have told me they think 2010 is the earliest there should be any changes in ISO 9001.
On the other hand, there may be a valid need to clarify some requirements. Hooper says, “A major input for the amendment of ISO 9001 is the TC 176 interpretation process. Based on number of informal requests for interpretation TC 176 receives from the interpretation group, there are a number of places in the ISO 9001 text where further clarification is clearly warranted.
Hooper says he will obtain a summary of ISO 9001 clarification opportunities from the interpretation group and then draft the justification study this summer.
While it is possible feedback will provide evidence of the need for more substantive changes, it is likely any needed changes could be handled with an amendment to ISO 9001:2000 rather than a full revision.
Possible Scenario for ISO 9004
ISO 9004 may prove to be quite a different situation. When ISO 9004: 2000 was released, many in the standards world believed it fell short of providing an adequate bridge be-tween the requirements of ISO 9001 and the excellence criteria of the Malcolm Baldrige National Quality Award or its European counterpart, the European Foundation for Quality Management.
While there is also a wide range of possible ISO 9004 feedback, the most likely scenario appears to be a preponderance of feedback indicating ISO 9004 should be significantly strengthened to fit its intended role as a bridge beyond ISO 9001 toward excellence.
On the other hand, we could get feedback that the document is not needed at all. An unlikely possibility is feedback indicating a need for minor changes to ISO 9004.
While I can’t make assumptions regarding what final shape the feedback will take later this year, it may prove useful to have a plan based on what appears likely.
The WG 18 timelines provided in Figures 2 and 3 (p. 70) were based on the assumption that market feedback will indicate the need for an amendment (rather than a full revision) to ISO 9001 and a full revision to improve the maturity of ISO 9004.
Figure 2 illustrates the actions needed to get a first draft of both potential documents by October 2005. Thus, it is projected a committee draft of a simple amendment will be issued for ballot in the fall of next year. There would also be a working draft of a more substantial change to ISO 9004 issued for comment at the same time.
Figure 3 illustrates the path from these first drafts to the issue of a revision to ISO 9004 and an amendment to ISO 9001.
While it appears there is a lot of time and little action between April 2006 and completion, don’t forget ISO balloting takes a long time, and even small numbers of comments take considerable time to resolve.
Of course, this scenario assumes the amendment to ISO 9001 will be simple, requiring no working draft. It also assumes the design specifications for changes can be drafted and approved between the TC 176 meeting this fall and the end of the first quarter next year. I believe these assumptions are optimistic, and there is no certainty the design specifications will be approved on the first ballot.
Neither does the projected timeline take into account factors outside of the control of TC 176. The bottom line is we should have a few good years of stability before there are major changes to the requirements. That is good news.
Implementing and Auditing ISO 9001:2000
Even though the transition period is over and the systematic review has begun, life goes on for those who are still in the process of implementing ISO 9001:2000. TC 176 remains committed to providing up-to-date implementation guidance to those organizations.
Introduction and support packages for ISO 9001:2000 and ISO 9004:2000, listed in Table 1 (p. 70), are updated as needed and available for free download at http://www.bsi.org.uk/iso-tc176-sc2.
For those involved in auditing to ISO 9001:2000, the ISO auditing practices group has a website at http://isotc176sc2.elysium-ltd.net/APG_index.html where you can get downloads on a variety of subjects. Since early 2003 the site has provided articles on the following subjects:
- Identifying processes.
- Understanding the process ap-proach.
- Auditing processes that areneeded only “where appropriate.”
- Demonstrating conformity to the standard.
- Linking an audit of a particular task, activity or process to the overall system.
- Auditing continual improvement.
- Auditing a quality management system (QMS) that has minimum documentation.
- Auditing top management pro-cesses.
- The role and value of the audit checklist.
- The scope of ISO 9001:2000, the scope of a QMS and defining “scope of certification.”
- Value added auditing.
- Auditing competence and the effectiveness of actions taken.
The auditing practices group is a joint project of ISO TC 176 and the International Accreditation Forum (IAF). The articles produced by the group are not official guidance since they have not been subjected to a formal review process within either TC 176 or IAF. On the other hand, they do contain many ideas that may prove useful to both auditors and those implementing a QMS to meet the requirements of ISO 9001.
JOHN E. “JACK” WEST is a management consultant in the areas of productivity and quality. He served on the board of examiners for the Malcolm Baldrige National Quality Award and is now chair of the U.S. technical advisory group to ISO Technical Committee 176 and lead delegate to the International Organization for Standardization committee responsible for the ISO 9000 family of quality management standards. He is co-author of ISO 9001:2000 Explained, published by ASQ Quality Press.