ANSI/ASQ QE19011S-2008
This American National Standard provides guidance on the principles of auditing, managing audit programs, conducting quality management system audits and environmental management system audits as well as the competence of quality and environmental management system auditors. It is applicable to all organizations having a need to conduct internal or external quality and/or environmental management system audits or manage an audit program.
The supplemental text contained in this document provides additional guidance to users to augment the International Standard. In particular, additional guidance is provided for small organizations that may wish to consider its application to the full range of audit activities (i.e., first, second, and third-party audits) and for any users that wish to apply the standard to internal (first-party) audits and external supplier (second-party) audits.
Since the definition of small organizations may vary, the concept of a small organization in this Supplement relates not only to the size of the organization but also to the complexity of the management system, the complexity of the product and processes, the organizations regulatory environment, and the effectiveness of communications within the organization. Therefore, the guidance given for small organizations may also apply to larger organizations with simple management systems, simple products and processes, little regulatory impact, and good communication processes among the personnel, functions and management levels.
Supplemental guidance for first-party audits, second-party audits, use by small organizations and OHSMS audits has been added to individual sections of this Supplement as applicable.