More on the approval of ISO 9001 : 2000

[Roger Eastin]

A colleague of mine who knows someone on the ISO9000:2000 committee says that a number of things have come up recently to the extent that this "committee" person told my colleague to toss the 2nd draft of ISO9000:2000 standard and that the 3rd draft is coming "soon". As I mentioned in a discussion in the TR16949 forum, there are certain legal questions beginning to surface, especially in the area of continuous improvement (there may be other areas as well - I don't know). The FDA is expressing some concern about using the continuous improvement language in the 2000 draft. Apparently, they are concerned that pharmaceutical and other FDA-regulated companies may be held liable if they don't show continuous improvement and they've documented that they will pursue continuous improvement in their procedures. Also, the fact that the 2000 version has radically reformatted the standard itself is troubling to a number of members of the committee. There are other things driving this concern as well, but it apparently has gotten to the point where companies may be given the option of retaining their registration to the 1994 version or upgrading to the 2000 version. Hence, the 2000 version would NOT supercede the 1994 version. My colleague told me that some of the wording in the next draft of the 2000 version has been watered down to the extent that he said it will be more difficult to audit to the standard. For instance, he said the section on quality systems is far less prescriptive so that you can comply with this section if you simply document the "quality system" you are doing now. He said the committee has even discussed taking the word "Quality" out of "Quality System" to make it easier for service industries to comply. (I am not sure, nor was he, how this would help service industries comply without being confused what the standard was needed for in the first place!) Hopefully, these points are just some frustration expressed by a committee member about what he perceives to be "watering down" the standard. However, my colleague thought that there was enough substance there to be concerned about the viability of the 2000 standard. If these points are true and hold up, this would seem to undermine much of the progress that has been made by ISO9000 up to now. Can anyone else corroborate these points?

[Marc]

Subject: quick announcement
Date: Fri, 25 Jun 1999 22:55:08 -0400

Open Discussion of the Year 2000 Version of ISO 9000
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Latest word from England is that it looks like TC-176 is going to accept the 2nd draft of ISO 9001 and 9004 pretty much as they stand. Only issue left to resolve is whether to number all items as section 4, just like the 1994 version. Let me know if you hear different.

Richard Clements

[Roger Eastin]

Hmmm...looks like we have a bit of disagreement here. Perhaps what I heard (2nd hand at that)was just some bad blood over the 2000 version. On the other hand, I am not sure how this ISO approval thing works. Yesterday, I saw in an ASQ publication that TC176(the American committee)was looking for people to give feedback on the latest 2000 version in a meeting they are having in September. Oh well, life goes on...

[Russ Jackson]

Typically, the ISO process goes through several committee drafts (CD) before reaching the DIS (draft international standard) stage for final comments prior to being issued as the final procedure. Currently the ISO 9000 series is at CD-2 stage and comments are being received through sometime in August for consideration at the TC 176 meeting in September. I doubt very seriously that TC176 will short circuit the planned schedule of going from CD-2 to DIS and thence to the published proceure. The transition schedule which shows the various stages and the integration of the final procedures into existing quality systems may be reviewed at the site ***DEAD LINK REMOVED***

As I recall, the drafts from TC176 are working documents until the procedures are submitted as a DIS for acceptance by participating ISO members (country representatives).

[This message has been edited by Russ Jackson (edited 02 July 1999).]

[Marc]

Thanks for the info, Russ!

Well, we got the DIS and It's still renumbered. Continual (not continuous) improvement is still in.

Does anyone really want to continue to be registered to the 1994 standard once the new standard is out?

Initially the RAB announced that companies seeking new (accredited) Registrations to ISO 9001:94 could do so up to 6 months after the release of ISO 9001:2000. Now they (RAB) are saying that you can get an accredited certificate to ISO 9001:94 up to 3 years after the release of ISO 9001:2000.

Are companies really going to "hold it against" another company if they are certified to ISO 9001:94? I doubt it.

[Aaron Lupo]

Yes but could companies who are 9001 : 2000 certified use it as a I am one up on you type thing. Which in turn say why are you not certified to the new standards yet? Which if you work for a small company that is just paying lip service to ISO will take the full 3 years to certify, and in my opinion could make it hard to bring in new business when there is someone out there who is 9001 : 2000 Certified that does the same thing you do. I as a customer would have to step back and ask why are you not certified and Company x is?