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Volume 8 · Issue 11 · November 2003


19011S Draft Circulates for Comment
US Supplement to QMS/EMS Auditing Standard Takes Shape

Additional US-developed guidance on management system auditing has reached the stage of development that should result in its publication in early 2004. On October 1, 2003, the ANSI Z1 Joint Task Group (JTG) on Auditing began the process of circulating a Committee Draft (CD) of a proposed US supplement to ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing, for review and comment.

Titled BSR/ASQ QE 19011S, Guidelines for Quality and/or Environmental Management Systems Auditing - U.S. Version with Supplemental Guidance Added, the CD began to circulate in October 2003 among the members of the two subcommittees on quality management and environmental management of the American National Standards Institute (ANSI) Z1 Committee. Comments from members of the Z1 Environmental Management Subcommittee and the Z1 Quality Management Subcommittee are due back by November 30, 2003, to Patricia Kopp Ghanam of ASQ, who serves as Administrator for the US Technical Advisory Groups (TAGs) to ISO Technical Committees (TCs) 176 and 207, which are responsible for the ISO 9000 quality management and ISO 14000 environmental management standards respectively.

“The purpose of the Supplement is to provide needed guidance on first-party (internal) audits, second-party (supplier) audits and use by small organizations,” noted John Stratton and Gary Johnson, Co-Chairs of the JTG, in their letter to the Z1 subcommittees accompanying the CD.

“While the scope of the International Standard, ISO 19011, was to include the full range of auditing activities, the United States did not believe that sufficient guidance was provided in the final version of ISO 19011:2002 in these areas. ISO 19011:2002 seemed to focus on third-party audits, particularly [registration] audit situations, and contained some guidance that would be difficult to apply or inappropriate for some internal audits or small organizations. The US TAGs to ISO/TC 176 and ISO/TC 207 found that ISO 19011:2002 was insufficient to meet the needs of the US marketplace and user community.”

Stratton and Johnson, who served on the Joint Working Group on Quality and Environmental Auditing (JWG) that drafted ISO 19011:2002, also reported that “several other countries have expressed similar concerns about the scope of ISO 19011:2002 and have indicated their interest in this Supplement” since drafting of QE 19011S began in March 2003. As reported previously, QE 19011S is being drafted along the lines of ISO 9004:2000—which contains the text of ISO 9001:2000 in boxes—with the text of ISO 19011:2002 in boxes within the Supplement. “No changes to the ISO text have been made, nor will any changes to that text be permitted in this document,” added Stratton and Johnson.

Additional information and guidance have been included for most clauses and subclauses of QE 19011S, as shown in the sidebar on the next page. This supplemental guidance takes one of four forms:

  1. General guidance for all audit situations
  2. Guidance specific to internal audits
  3. Guidance specific to second-party audits
  4. Guidance for use by small organizations.

In fact, when there is guidance relative to some of forms 2, 3 and 4 but not to all, QE 19011S states that “there is no additional guidance for this clause” under a heading for the form(s) for which additional guidance is not provided. Because the period of review and comment could lead to changes in the supplemental guidance found in the CD of 19011S, THE OUTLOOK will not provide an analysis or additional information regarding the guidance in the CD.

Such information will be provided once the comments on the US supplement have been reviewed and revised and subsequent steps have been taken to finalize the drafting of QE 19011S.

Clauses and Subclauses of ISO 19011:2002 to Which QE 19011S Adds Guidance

1. Scope

4. Principles of Auditing

5.1 Managing an Audit Program—General

5.2.1 Audit Program Objectives and Extent—Objectives of an Audit Program

5.2.2 Extent of an Audit Program

5.3.1 Audit Program Responsibilities, Resources and Procedures—Audit Program Responsibilities

5.3.2 Audit Program Resources

5.3.3 Audit Program Procedures

5.4 Audit Program Implementation

5.5 Audit Program Records

5.6 Audit Program Monitoring and Reviewing

6.1 Audit Activities—General

6.2.1 Initiating the Audit—Appointing the Audit Team Leader

6.2.2 Defining Audit Objectives, Scope and Criteria

6.2.3 Determining the Feasibility of the Audit

6.2.4 Selecting the Audit Team

6.2.5 Establishing Initial Contact With the Auditee

6.3 Conducting Document Review

6.4.1 Preparing for the On-Site Audit Activities—Preparing the Audit Plan

6.4.3 Preparing Work Documents

6.5.1 Conducting On-Site Audit Activities—Conducting the Opening Meeting

6.5.3 Roles and Responsibilities of Guides and Observers

6.5.4 Collecting and Verifying Information (including practical help on conducting interviews)

6.5.5 Generating Audit Findings

6.5.6 Preparing Audit Conclusions

6.5.7 Conducting the Closing Meeting

6.6.1 Preparing, Approving and Distributing the Audit Report—Preparing the Audit Report

6.6.2 Approving and Distributing the Audit Report

6.7 Completing the Audit

6.8 Conducting Audit Follow-Up

7.1 Competence and Evaluation of Auditors—General

7.2 Personal Attributes

7.3.1 Knowledge and Skills—Generic Knowledge and Skills of [QMS] and [EMS] Auditors

7.3.2 Generic Knowledge and Skills of Audit Team Leaders

7.3.3 Specific Knowledge and Skills of [QMS] and [EMS] Auditors

7.3.4 Specific Knowledge and Skills of Environmental Management Systems Auditors

7.4.1 Education, Work Experience, Auditor Training and Audit Experience—Auditors

7.4.2 Audit Team Leaders

7.4.3 Auditors Who Audit Both Quality and Environmental Management Systems

7.4.4 Levels of Education, Work Experience, Auditor Training and Audit Experience

7.5.1 Maintenance and Improvement of Competence—Continual Professional Development

7.5.2 Maintenance of Auditing Ability

7.6.1 Auditor Evaluation—General

7.6.2 Evaluation Process, including text relating to Table 2, Evaluation Methods, and Table 3, Application of the Evaluation Process for an Auditor in a Hypothetical Internal Audit Programme