Auditing Process-based Quality Management Systems
Auditing Process-based Quality Management Systems
Charlie Cianfrani and Jack West
? C. A. Cianfrani & J. E. West January, 2013
Agenda
? Course objectives ? What is an audit? ? How to prepare for and plan an audit ? How to conduct an audit ? How to report on an audit ? Course closing
? C. A. Cianfrani & J. E. West January, 2013
Course Objectives
? Learn the basics of performing internal audits of a QMS based on the process approach
? Process mentality ? Consider policy, objectives, processes,
products and organizational alignment ? Prepare an audit plan ? Conduct an audit ? Document findings ? Write an audit report ? Ensure follow-up on corrective actions
? C. A. Cianfrani & J. E. West January, 2013
Agenda
? Course objectives ? Introductions ? What is an audit? ? How to prepare for and plan an audit ? How to conduct an audit ? How to report on an audit ? Course closing
? C. A. Cianfrani & J. E. West January, 2013
What is an audit?
An audit* is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled
* Definition is from both ? ISO 9000:2005 Quality management systems-
Fundamentals and vocabulary ? ISO 19011:2011 Guidelines for quality and/or
environmental management systems auditing
? C. A. Cianfrani & J. E. West January, 2013
What is an internal audit?
An internal quality audit is an audit that is performed by or at the direction of members of the organization
? C. A. Cianfrani & J. E. West January, 2013
Why audit?
Possible reasons to audit:
? ensure compliance with ISO 9001:2008 ? ensure compliance with organization
requirements ? ensure compliance with regulatory
requirements ? ensure the QMS is effectively implemented
and maintained
? C. A. Cianfrani & J. E. West January, 2013
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