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ISO 9000 & AUDITS WORLD CONFERENCE

ISO 9001 Auditing – The Dilemma

Presenter:   David Auda, Reliability/Safety Engineer, Volvo/Mack truck, Greensboro, North Carolina, USA

Keywords: Bayesian Thinking, Effectiveness, Objectives, Double Loop Learning

Industry: Healthcare

Level: Intermediate


ABSTRACT

Experience can be a good teacher, yet it requires a student that is prepared for and capable of learning. Even when the lesson is a hard one, it may be that the learning somehow seems to have been missed and no effective change is realized. In the case of the 9001 audits, this would be evident through the continued persistence of new and repeat issues in spite of the fact that audits are performed and have findings. For many this is the proverbial elephant in the room. This cycle of audit, findings, corrections, and issues encounters continues and from the viewpoint of the casual observer, seems to be a reasonably robust process in itself. There is of course the natural variation of any system which we could refer to as the noise floor, yet there are few organizations that have achieved such a high level of control that the focus in now turned to squeezing the margin of the noise. This presentation focuses on the exceptions to this and examines the audit process providing some suggestions on steps that can be taken as well as changes that need to be made to realign the activity with its original intentions.



Government Organizations




Corporations

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(*) based on previous conference attendance






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