Volume 8 · Issue 3 · March 2003

Contents

Drafting of US Supplement to EA/QA Standard Begins
US JTG May Have "19011S" Ready by Year’s End

Drafting of a supplemental document that will provide additional guidance for internal, second-party and simple third-party management system audits began March 12-13, 2003, in Dallas. The Joint Task Group on 19011 Supplement (JTG) began the drafting process at its second meeting and expects to complete a first draft that will circulate for review within the ANSI ASC Z1 Committee and the US Technical Advisory Groups (TAGs) to ISO Technical Committee (TC) 207 and TC 176 by the time they meet in August 2003. The US supplement—tentatively titled 19011S—could be approved and published by late 2003 or early 2004.

At a time when the American National Standards Institute (ANSI) ASC Z1 Committee on QEDS (Quality, Environment, Dependability and Statistics) is balloting ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing, for adoption as an American National Standard, the JTG has begun the development of a US supplement to ISO 19011 that will address those areas where the US TAGs and their auditing SubTAGs have identified a strong need for additional guidance. The JTG is a Z1 task group made up of auditing experts from the Z1 subcommittees on environmental and quality management. It was created after Z1 balloting on a New Work Item Proposal for a US supplement to ISO 19011 concluded with overwhelming approval on August 19, 2002.

Development of 19011S is the by-product of efforts by the US delegation to the Joint Working Group on Quality and Environmental Auditing (JWG) to have additional guidance incorporated in ISO 19011 at the Draft International Standard (DIS) stage on the following areas:

• Internal auditing program management and selection of internal auditors
• Second-party audit program management and auditor competency
• Third-party audits of a small to medium-sized enterprise (SME) and required auditor competency.

After the JWG declined to consider a US proposed rewrite of one section of ISO/DIS 19011 and some proposed additional guidance in several other sections dealing with audit program management and the conducting of an audit, the US delegates and the auditing subgroups of the US TAGs decided to propose development of a US supplement once ISO 19011 was published.

The JTG held its first meeting on August 28, 2002, in Washington, DC, during the concurrent meetings of the US TAGs to TC 207 and TC 176. In a report to the US TAG to TC 176 on March 13, 2003, John H. Stratton, Chair of US Task Group (TG) 19011 to TC 176’s Subcommittee (SC) 3 and Co-Chair of the JTG, indicated that the JTG planned to complete draft language in Dallas on the two most complex parts of ISO 19011, which also require the most significant additional guidance:

1. Section 5, Managing an Audit Programme
2. Section 7, Competence of Auditors.

According to Stratton, who served as Chair of the US delegation to the JWG, the JTG completed draft language to supplement Section 5 on March 12 and expected to complete draft language for Section 7 by the conclusion of its meeting on March 13. "A subgroup of the JTG will complete the draft by developing guidance where needed to supplement the other sections of ISO 19011," noted Stratton, who added, "The draft should circulate within the JTG for review, comment and revision this spring, with the expectation that we will be able to circulate the draft—or a revision—more widely by the summer. Our expectation is that a draft will be out for review by the Z1 subcommittees by the time of the TAG meetings the week of August 25, 2003."

Technically, the JTG is an ANSI ASC Z1 on QEDS task group; therefore, anything it produces will be circulated for balloting only by active ASC Z1 on QEDS members. Z1 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.

However, members of the US TAGs to TC 207 and TC 176 are eligible for Z1 membership if they have participated actively in balloting within Z1. The JTG is likely to also seek the feedback of these TAGs, which developed the US positions on and provided the US delegates for the drafting of ISO 19011.

JTG Starts With ISO/DIS 19011 Language
Stratton indicated that the JTG had used the proposed language submitted in balloting on ISO/DIS 19011 as a starting point for the drafting of 19011S. As reported in late 2001 and early 2002, the US comments on the DIS proposed a rewrite of Section 7 to increase the guidance it offered on the selection of auditors for a variety of audit program types and sizes, not just for complex third-party auditing. The proposed revision involved reorganization of existing text, with some content being placed into Practical Help boxes, and the addition of limited new text to provide more balance to ISO 19011’s guidance so that it covered all types of audits, not just third-party audits.

The US proposal also expanded on what is in Table 1, Example of Levels of Education, Work Experience, Auditor Training and Audit Experience for Auditors Conducting Certification or Similar Audits, which is geared in ISO 19011 to the competency required for complex third-party audit situations. The proposed revision incorporated several Practical Help boxes to add illustrations of competence levels for internal auditors and for external auditors of less complicated organizations.

Gary L. Johnson, Environmental Engineer at the US Environmental Protection Agency, who is a representative of the US TAG to TC 207, was a US delegate to the JWG and is Co-Chair of the JTG, told THE OUTLOOK that he and Stratton had evaluated the draft language that the United States had proposed on the DIS to see what could be used now that ISO 19011 has been published. "We will need to make some adjustments, since what the JTG develops has to be a supplement to ISO 19011. For example, part of the proposed rewrite of Section 7 involved putting Table 1 into a Practical Help Box and adding several more boxes with examples suitable to internal, second-party and SME third-party audits. But Table 1 in ISO 19011 is in the text, not a box."

Stratton indicated to the US TAG to TC 176 that the JTG is exploring if 19011S could include the verbatim text of ISO 19011, or the American National Standard equivalent, in boxes. The supplemental guidance would be outside the boxes, as was done in ISO 9004:2000 where the text of ISO 9001:2000 is contained in boxes. "There are copyright and other issues that we will need to explore," noted Stratton.

Another idea being considered by the JTG is the inclusion of an annex to 19011S to address issues surrounding the concept of process auditing. During an initial presentation by Stratton at the opening plenary of the US TAG to TC 176 on March 12, several TAG members recommended that the JTG consider addressing the concept of process auditing or the auditing of a process-based management system. TC 176 and the TAG have identified this concept as one that many auditors, internal and external, have been having a great deal of difficulty understanding and effectively accomplishing.

"I brought this suggestion to the JTG and we considered including this in the supplement," acknowledged Stratton in his report on March 13. "However, auditing of a process approach-based system is not appropriate to the scope of the supplement, but it would be suitable to include an annex that would begin to propose solutions to the process auditing problem."

The JTG will also be consulting with several sector groups to discuss auditing guidance that has been developed to support sector-specific QMS requirements. For instance, the JTG is expected to contact a group within the Automotive Industry Action Group that developed auditing guidelines for use in the automotive sector with ISO Technical Specification 16949:2002, which is aligned with ISO 9001:2000 and therefore requires QS-9000-conforming organizations to transition to process approach-based management systems and the auditing of them.

THE OUTLOOK will provide additional coverage of 19011S as the JTG continues its work on the draft and on the balloting of ISO 19011 for adoption as an American National Standard. The US SubTAG to TC 207/SC 2, which is responsible for auditing standards in the ISO 14000 series, did not meet in Dallas, although several members of SubTAG 2 participated in the JTG meeting, which occurred simultaneous to the US TAG to TC 176 meeting.

Visit the ISO 9000:2000 Product Support Initiative web pages, located at the ASQ Standards Group web site (http://standardsgroup.asq.org), to obtain additional information about the PSI, survey results and ISO 9000:2000

A report will also be provided in the April 2003 issue on the meeting of the US TAG to TC 176 in Dallas, which included reports on the revision of several existing standards in the ISO 9000 series, reports on and sessions relating to the drafting of several new standards, consideration of proposed comments on the second committee draft of ISO 14001, a presentation from the American Petroleum Institute on the revision of API Q1 to align with ISO 9001:2000 and meetings of US TG 9001/9004 and of the ISO 9000:2000 Product Support Initiative (PSI).

Among the activities discussed at the PSI meeting was the posting of an ISO 9004:2000 Survey on the PSI web site to obtain feedback on the performance improvements standard and its use. The latest issue of PSI’s ISO Curves provides a snapshot of the responses to three questions on the ISO 9004:2000 Survey. All issues of the ISO Curves can be found at the ISO 9000:2000 Product Support Initiative web pages, located at the ASQ Standards Group web site (http://standardsgroup.asq.org).