R
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?
