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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