Special Audit Guidance in QE19011S-2004

Many of you receiving this newsletter are auditors. Depending on when you were trained, you may have received a copy of ISO 10011 (now withdrawn), or its replacement,  ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing. All RABQSA-certified auditor training courses are now based on ISO 19011.

In the USA, we have another source of audit guidance, ANSI/ISO/ASQ QE19011S-2004. It contains the full text of ISO 19011:2002, along with supplemental text intended for organizations with simple systems. The additional guidance is provided for small organizations that may wish to consider its application to the full range of audit activities (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 a “small” organization may vary, the concept of a small organization in the 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 organization’s 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 communications processes among the personnel, functions, and management levels.

For example, ISO 19011 states in clause 6.3 that the auditee’s documentation should be reviewed prior to the on-site audit. After providing additional guidance, the standard goes on to say the document review might be deferred until the on-site audit, if this is not detrimental to the effectiveness of the conduct of the audit.

QE19011S expands on 6.3 by stating that once initial conformity of the documents has been established, an internal audit team may only need to review those documents in which changes have been made since the last audit of the area, unless the audit criteria change. The supplement adds that documents specific to a particular area, e.g., work instructions, can be reviewed while auditing that area rather than during a separate document review.

An electronic version of QE19011S-2004 can be downloaded for an ASQ member price of $72.00 at <http://e-standards.asq.org/perl/catalog.cgi?item=T19011SE>.