Webinar: How To Prepare For FDA Migration To ISO 13485 And MDSAP

[fa icon="calendar'] Mon, May 06, 2019 / by David Bolton


Media theorist Marshall McLuhan may not have had quality management for medical devices in mind when he coined the phrase “global village” in the 1960’s, but the fundamental interconnectedness of modern society has brought his concept to life. And while technology is at its core, the need for international harmony in the regulatory sphere is arguably a key QMS issue.

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Medical Devices ISO Standards Life Sciences Regulatory Compliance iso 13485

Regulating Sustainability: Finding Common Ground between Standards

[fa icon="calendar'] Thu, May 24, 2012 / by Tim Lozier

Sustainability is a common goal among many organizations in business today.  It is not only becoming a good practice for organizations to ensure they are adhering to their own internal standards, but it is also becoming a requirement from suppliers, consumer, and investors.  With the growing interest in sustainability (particularly environmental sustainability), the question arises, "What exactly should we be reporting, and to whom?"

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EHS Management ISO Standards

The Top 10 QMS and EHS Management Articles of 2011

[fa icon="calendar'] Thu, Dec 22, 2011 / by Tim Lozier

As 2011 comes to a close, I thought this would be a good time to take a look back on some of the most popular topics that have been written about in our humble blog.  That, and I'm one foot out the door, egg nog in hand, so...

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EHS Management Quality Management GFSI eMDR MedWatch ISO Standards Food and Beverage Safety

ISO Crazy: The Lighter Side of ISO Standards

[fa icon="calendar'] Thu, May 26, 2011 / by Tim Lozier

When I first started my career, I knew nothing about ISO.  In college, I got about a day's worth of ISO explanation in business school.  It was summed up as, "ISO 9000 is a management standard.....Deming.....Japan....quality management.......any questions?" 

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Quality Management ISO Standards

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