posted 08 December 1999 07:44 PM               

From: Dennis Arter Arter@Quality.Org

Report on US TAG Standards Group Meetings

The US Standards Group on Quality, Environment, Dependability and Statistics (QEDS) met in Crystal City, Virginia, the week of November 15, 1999. While many issues were discussed and work was conducted by all working groups, there were several issues surrounding the Draft International Standard (DIS) of ISO 9000:2000 series that bear reporting.

(The pre-publication editions of the DISs (available for translation) were provided to the members of Task Group (TG) 18 for their use in starting the development of a US position. These copies were retrieved after the meeting.)

The issues of concern to the US Technical Advisory Group (TAG), which formulates the US position on documents developed within ISO Technical Committee (TC) 176, are as follows:

A. Non-conformance

Although the requirements for non-conforming products (clause 4.13 in the 1994 edition) had remained virtually unchanged in the new version through the second committee draft (CD 2), the pre- publication version of the DIS being worked on by the International Organization of Standardization (ISO) now has some changes. These changes were apparently made to make the document easier to use in the service sector. This raises issues with manufacturing oriented people since some of the older requirements have been dropped and there are now no directions for the disposition of non-conforming products.

B. Documented procedures

Throughout the DIS, there has been a significant and intentional reduction in the number of places which have specific requirements for documented procedures within the clauses. Although there is some general discussion in Section 4, some participants indicated that the DIS may go too far in eliminating requirements for procedures.

C. Document vs. Record

There are lingering questions concerning the use of documentation terms. In specific, the definitions of "record" and "document" needs to be clarified. This is not considered a significant concern.

ISO 19011, the integrated standard for internal auditing of quality and environmental management systems, is planned for release as a DIS in the September-October 2000 time frame to correspond with the release of ISO 9001:2000 as an FDIS. This will be one of the four core documents contained in the ISO 9000 family. This is down from dozens of documents to ISO 9000, ISO 9001, ISO 9004 and ISO 19011. There is also one international document that is frequently included with these four documents: ISO 10012 on measuring equipment.