ISO 9001:2015 has significant structural changes that differentiate it from the previous standard. The new high-level structure is common to all ISO management system standards (i.e., quality, environmental,  IT security) and enables us to start looking at integration of these systems. There is a standard core text and structure and, important for ISO 9001, there is now the inclusion of services.

Our Sept. 8, 2017, episode of QDL examined a different way to conduct clinical trials, discussed fixing problems before they occur, and in the aftermath of Hurricane Harvey looked at resources for building a more resilient and sustainable infrastructure.

“A Better Way to Design Clinical Trials”

In the last week of August 2017, two extreme weather events occurred on opposite sides of the world. Hurricane Harvey brought record-breaking rain and catastrophic flooding to Houston, Texas, causing loss of life, mass evacuation of people, and damage estimated to be in billions of dollars. Around the same time, Mumbai, India, received extremely heavy monsoon rains, flooding roads, crippling the city’s public transport, and stranding thousands of people.

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A new report by Jupiter Research says $8 trillion will be the price tag—within the next five years—of cyber attacks against businesses around the world. Hacks and other forms of digital theft are accelerating despite what would seem to be nonstop efforts by corporations to harden their networks with anti-virus software, network intrusion filters, virtual private networks, vulnerability testing, and all manner of expensive gadgets to keep the bad guys out.

Value has found a place at the heart of healthcare innovation. For money-conscious governments and other actors in the system, it’s not enough that a new treatment be beneficial and safe. It also needs to be cost effective.

On Friday, Sept. 1, 2017, QDL included news about the disaster in Texas and no apocalypse in retail, an interview covering a different approach to failure modes and effects analyses, a feature article on consumer views about for-profit social-benefit enterprises, and a great new Tech Corner demo. Here’s a closer look:

Have you ever wondered who collects the clothes you stuff into that donation drop box in your neighborhood? Chances are, you assumed it was a nonprofit, but that box actually may instead belong to a for-profit social venture. If you don’t know what that means, you’re not alone.

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Scientists at the Fermi National Accelerator Laboratory (Fermilab) are working on research projects that aim to answer fundamental physics questions. How did the universe begin? What are dark matter and dark energy? What is the mass hierarchy of neutrinos? Are there other undiscovered particles beyond the currently known Standard Model of Particle Physics?