New ISO 19011- Auditing Guidelines for ISO 9001 and other standards
By Jim Robison, 3rd Party Registrar Lead Auditor
ISO 19011 is a terrific auditing guideline that will and can make your audit process more effective. It replace the guideline called ISO 10011.
Terms
ISO 19011 has several terms that both Internal and Lead Auditors need to learn. For example, the term Audit Criteria is 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 are now 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 9001:2008 and ISO 140001 standards.
Principles of ISO 19011
ISO 19011 is focused on reemphasizing solid auditing principles. These are the most prominent:
- Independence: Auditors cannot audit work where a conflict of interest would arise.
- Ethical Conduct: Actions that may influence the results of an audit should be avoided.
- Fair Presentation: Obligation to truthfully & accurately report QMS inadequacies.
- Evidence: The rational basis for reaching audit conclusions based on audit criteria.
- 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.
Auditing under ISO 19011
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.
Conclusions
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 or other standard audits. Be sure to include ISO 19011 in your search for a training course. Be sure to include ISO 19011 in your search for a Lead Auditor Transition course or the 5-day Lead Auditor course training.
