Aaron Troschinetz

Aaron Troschinetz is the technical manager at NSF International Strategic Registrations (NSF-ISR, Ann Arbor, MI) where he oversees the technical support of all management system programs. For more information, visit www.nsf-isr.org.

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ISO 13485: Medical Devices and Risk Management

January 5, 2010
The standard known as ISO 13485: 2003 - Medical devices - quality management systems - Requirements for regulatory purposes, has become the global standard for those involved in the manufacture of medical devices.
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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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