Articles by Tim Mohn

Learning Quality from Pharmaceuticals

April 1, 2010
The quality processes used in pharmaceuticals can help other manufacturers learn quality processes and ways to further improve efficiencies.
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Bill Arbogast explains his perspective on quality, ISO 9001, and how to manage inevitable business changes.


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A Practical Field Guide for ISO 9001:2008

The purpose of this field guide is to assist organizations, step by step, in implementing a quality management system (QMS) in conformance with ISO 9001:2008, whether from scratch or by transitioning from ISO 9001:2000. It examines each sub-clause of Sections 4–8 of ISO 9001:2008, which contain the requirements, and gives a list of the documentation/documents required, internal audit questions, a summary of management’s responsibilities, and a flowchart of the steps that need to be undertaken to satisfy the requirements.

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