Volume 7 · Issue 9 · September 2002

Contents

ISO/FDIS 19011 Approved; US Supplement to Follow
ISO EMS/QMS Auditing Standard Approved

Voting Results On ISO/FDIS 19011   Yes No Abst ISO Member Bodies* 42 0 0 US TAG to TC 176 80 0 6 US TAG to TC 207 58 0 4 * Although ISO member bodies voted separately for TC 176 and TC 207 ballots, they were encouraged to agree on a unified vote on ISO 19011 ballots. "Yes" indicates votes to approve; "No" votes to disapprove; and "Abst" votes to abstain.

Voting on the Final Draft International Standard (FDIS) of ISO 19011, Guidelines for quality and/or environmental management systems auditing, concluded internationally on August 13, 2002, with unanimous approval within both ISO Technical Committee (TC) 207, Environmental Management, and ISO/TC 176, Quality Management and Quality Assurance (see box below for balloting results). The results mean that the first standard developed jointly by two ISO/TCs will be published by November 2002.

However, because of concerns within the US Technical Advisory Groups (TAGs) to TCs 176 and 207 with the lack of guidance in ISO/FDIS 19011 on certain issues, the members of the American National Standards Institute (ANSI) Z1 Committee have delayed voting on approval of ISO 19011 as an American National Standard. Instead, Z1 balloted a New Work Item Proposal (NWIP) for the drafting of a US supplement to ISO 19011 that concluded on August 19, 2002, with 88.5% voting "Yes" on the NWIP.

The US supplement, which is tentatively titled 19011S, will be developed by a newly formed Joint Task Group on 19011 Supplement (JTG), which will consist of auditing experts from the Z1 subcommittees on environmental and quality management.

Voting Results On ANSI ASC Z1 NWIP for 19011S   Yes No Abst Z1 on QEDS 46 2 4

The JTG will be co-chaired by Gary L. Johnson, Environmental Engineer at the US Environmental Protection Agency, a representative of the US TAG to TC 207 and a US delegate to the Joint Working Group on Quality and Environmental Auditing (JWG) that drafted ISO 19011, and John H. Stratton, Chair of US Task Group (TG) 19011 to TC 176’s Subcommittee 3 and Chair of the US delegation to the JWG.

The JTG met for the first time on August 28, 2002, in Washington, DC, during the concurrent meetings of the US TAGs to TC 207 and TC 176 and expects to complete work on 19011S as soon as September 2003.

What Will 19011S Look Like?
The JTG is directed by the Z1 NWIP to develop a US guidance document to fill perceived voids in ISO 19011, according to Johnson and Stratton. Among the voids that were identified in the JTG meeting on August 28 are a lack of guidance on:

• Internal audits
• Auditing of smaller organizations
• Clarity on the competence of auditors in a range of audit types and sizes
• The application of audit program management.

The format of 19011S that the JTG has agreed upon is to have the verbatim text of ISO 19011 with the US supplementary guidance interspersed in a format similar to that used in ISO 9004:2000, Quality management systems—Guidelines for performance improvements. "There will be no tinkering with the ISO 19011 text," noted Stratton.

In a report to the US TAG to TC 176 on August 29, 2002, Stratton indicated that the JTG had made the following progress at its first meeting:

• Development of a strategy for the drafting of the supplementary guidance, including the identification of voids in ISO/FDIS 19011
• The creation of an action plan detailing work assignments for JTG members and a defined process, including plans for work meetings, primarily through conference calls, e-mail and other communications, and a schedule of deadlines for the production, review and revising of a draft document within the JTG
• The action plan sets a March 2003 date for completing a revision of the draft, most likely to be accomplished at a JTG meeting when the US TAGs next meet in Dallas March 10-13, 2002
• Wider distribution of the revised draft in April 2003 for review by all members of the US TAGs to TC 207 and TC 176 and other relevant groups
• Plans to address comments from the wider review, with ANSI to circulate a balloting draft to Z1 Committee members in the summer of 2003 and with expected publication of a final document by January 2004, with September 2003 as a target.

Patricia Kopp Ghanam of ASQ, who is the Administrator for the US TAGs to TC 176 and TC 207, reminded members of both TAGs at the Washington meetings that the JTG is an ANSI ASC Z1 on QEDS (Quality, Environment, Dependability and Statistics) task group and therefore anything it produces will be circulated for balloting only by active ASC Z1 on QEDS members. The ASC Z1 on QEDS is responsible for adopting ISO and other international standards as American National Standards and drafting American National Standards in areas that include environmental and quality management.

Ghanam, who will be sending out a reminder notice to all members of the US TAGs to TC 176 and TC 207, indicated that membership on the ASC Z1 on QEDS is not tied to membership in a TAG. "To remain an active member of Z1, members of the two TAGs must be members of either the ASC Z1 Quality Management Subcommittee or the ASC Z1 Environmental Management Subcommittee and vote on ballots for the adoption of ISO standards as American National Standards," advised Ghanam. TAG members who are in doubt about their Z1 membership should contact ASQ.

It is expected that a source for some of the content for the supplement will be the proposed changes and additions to ISO 19011 that the United States submitted with its comments on the Draft International Standard version. The plan is for ASQ to offer the ISO version of ISO 19011 in the interim and have a "statement of added-value" in the US version, 19011S.

THE OUTLOOK will provide additional information as it becomes available.

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