By Jim Robison, 3rd Party Registrar Lead Auditor

ISO 19011. Have you heard about it yet? If not, you will soon. This is latest ISO auditing guideline that will be released in mid 2001. It is now in a Committee Draft (CD) stage and work continues to make this the core Auditor guideline for ISO 9001:2000 Quality Management Systems (QMS) and ISO 14001 Environmental Management System (EMS) auditing. ISO 19011 will replace the current auditing guideline called ISO 10011.

ISO 19011 has several new terms that both Internal and Lead Auditors need to learn. For example, the term Audit Criteria has been introduced. Audit criteria are now defined as "The set of policies, procedures or other requirements against which collected evidence is compared". Also, the term Audit Findings is redefined under ISO 19011 as "The results of the evaluation of the collected audit evidence against audit criteria". Many of us used to call a Finding a type of Noncompliance, but not any more under 19011. Terms such as Concerns, Observations, and Opportunities for Improvements, as well as Positive Observations and Noncompliances may now be defined as Audit Findings. ISO 19011 defines Audit Conclusions as "The outcome of an audit reached by the audit team after consideration of all the audit findings". Confusing? Not really, you will just have to learn the new terms. Terms and definitions need to be understood and used consistently by auditors under the new ISO 9001:2000 and ISO 140001 standards.

ISO 19011 is focused on reemphasizing solid auditing principles. These are the most prominent:

1. Independence: Auditors cannot audit work where a conflict of interest would arise.

2. Ethical Conduct: Actions that may influence the results of an audit should be avoided.

3. Fair Presentation: Obligation to truthfully & accurately report QMS inadequacies.

4. Evidence: The rational basis for reaching audit conclusions based on audit criteria.

5. Due Audit Care: The reasonable care in all matters and the completeness of the audit report. Auditors should avoid errors that may comprise any of the above-mentioned principles.

Under these ISO 19011 principles, the audit output should result in an audit containing these distinctive characteristics:

• Objective, systematic and independent audits which produce information from management to improve operations.

• Authorized, planned and properly managed audits that have a clear purpose and used defined techniques.

• Relevant, reliable, sufficient and consistence audit evidence and audit conclusions that are reproducible.

• Competent auditors free from biases and any conflict of interest.

• A relationship between all parties involved in the audit that ensures confidentiality of the results.

• Appropriate audit sampling to obtain the required evidence of conformance.

It is the responsibility of the auditor, client and auditee to control these stated features of an audit activity, which are their responsibilities to ensure the highest value possible.

ISO 19011 offers a new and refreshing approach to the spell the myth that Auditors must find fault with one's QMS, or they are not doing their job. It's focus on continuous improvement and value added auditing makes this a must read for anyone that will be performing ISO 9001:2000 and ISO 14001 audits. Be sure to include ISO 19011 in your search for a Lead Auditor Transition course or the 5-day Lead Auditor course training.

Jim Robison is an RAB Registered Lead Auditor and provides both the ISO 9001:2000 two-day RAB approved Auditor Transition course and the 5-day RAB approved Lead Assessor course which includes the new ISO 19001 requirements. As an ASQ certified Quality Auditor, he conducts actual ISO 9001:2000 Registration audits, QS-9000 and EMS 14001 audits while also serving as the Lead Software trainer for the Harrington Group. Having over 17 years of industry experience, Jim is further qualified with an MBA and Engineering degree from the University of Michigan. To find out about courses on ISO 9001:2000 with ISO 19011 requirements, click here.