Nikki Willett

Nikki Willett is vice president of product marketing and regulatory affairs, Pilgrim Software Inc. (Tampa, FL). For more information, e-mail willettn@pilgrimsoftware.com or visit www.pilgrimsoftware.com .

ARTICLES

Quality Management: The Need for ISO 13485

January 1, 2011
The increasing need for quality medical devices is matched by the need for compliance with ISO 13485: 2003.
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Optimize Your Quality Management System

November 30, 2009
Quality management is not about compliance, rather, it is all about product safety and continuous improvement, and each time we optimize, we improve our preventive measures for avoiding the occurrence of costly defects.
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Bill Arbogast explains his perspective on quality, ISO 9001, and how to manage inevitable business changes.


Read: The 2013 Quality Professional of the Year

 
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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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