WHY CHANGE AT ALL?
As many of you who have worked with the ISO 9000 standards know, the standards are periodically updated. The last revision of the ISO 9001 standard was in the year 2000 (hence the title "ISO 9001:2000"). The next revision (technically an "amendment") is scheduled to be released by the end of 2008, probably around October.Any ISO standard goes through several formal steps on its way to final release. ISO 9001:2008 is currently at the DIS ("Draft International Standard") stage, meaning it is nearly complete. The draft of ISO 9001:2008 is now available for public review. The only step left is to finalize the language and then a formal committee vote.
Regardless of the schedule, most users of the ISO 9001:2000 standard (whether certified, conforming or preparing) want to know what is going to change in 2008. Those who went through the previous transition from ISO 9001:1994 to ISO 9001:2000 know first-hand the disruption that was caused by the significant changes introduced by the last revision. It was very costly for all certified companies to change over to the new version.
The good news is that the 2008 release should not have the same impact. In fact, the ISO technical committee (TC176) who develops the ISO 9000 series of standards is purposely planning the next release as an amendment rather than a formal revision. The difference is that an "amendment" is focused on making changes for clarification purposes only or for better alignment with ISO 14001, the standard for environmental management. With the 2008 release, the committee is purposely not intending to introduce substantive changes that will affect the QMS processes and documentation of currently certified organizations. Thus, the new ISO 9001:2008 standard should have limited impact on companies already certified.
WHAT CAN WE EXPECT?
Here are a few examples of the types of changes in the currently available DIS ISO 9001:2008 draft:
- There are some terminology changes that are intended to clarify ideas or make documentation more consistent - e.g. "devices" is changed to "equipment".
- There are several additional or revised "Notes" within the standard. However, notes are not considered part of the auditable requirements but are, instead, included for clarification.
- The phrase "where applicable" is used more extensively with regard to several requirements within the standard. This was done to help more organizations in various industries more easily apply the standard to their particular business.
- A number of sentences and paragraphs have been re-worded to be easier to understand and apply the language.
Bottom line is that there is nothing to worry about if you are already certified to ISO 9001:2000. The only likely impact would be on organizations that had previously misunderstood the intent of certain parts of the standard and, due to the clarifications in the 2008 version, it is recognized that the standard had been mistakenly applied incorrectly. A process or procedure here or there might need some minor modification in this case.
So, the upcoming release of ISO 9001:2008 should be a fairly simple transition for most certified organizations. If you are currently preparing for your initial ISO 9001 certification, there is no reason to delay or to change your approach. If you are correctly implementing an ISO 9001:2000 quality management system in preparation for your initial certification audit, the new standard will not impact you significantly. As usual, we expect there will be a 1 - 2 year "transition period" following the release of the new revision to make any necessary changes to comply with the new standard. But, as I have said, there aren't likely to be any substantive changes anyway.
