Standards Features

Peter Merrill's picture
Peter Merrill
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,...
Joe Bollard's picture
Joe Bollard
As of Sept. 14, 2018, ISO/TS 16949 certificates are longer valid, which means automotive suppliers must certify to the new version, IATF 16949. Transition audits are underway and will continue into...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
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...
DNV GL's picture
DNV GL
Sponsored Content 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...
Mike Richman's picture
Mike Richman
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...
Amie Whittington's picture
Amie Whittington
As discussed in my previous article, the Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under section 501(c)3. However, the IRS isn’t the...
Mike Richman's picture
Mike Richman
There was a lot of ground to cover on this week’s show… fortunately we had drones (I mean, unmanned aircraft systems) to help us cover it all. Here’s a quick flyby: “Girl Scouts Offer New Badges...
John Flaig's picture
John Flaig
Independence is an important issue in statistics, so I found the article, “Ethics, Auditing and Enron,” by Denis Arter and J. P. Russell, in the October 2003 issue of Quality Progress quite...
Chad Kymal's picture
Chad Kymal
Globally, there are more than 68,000 organizations certified to ISO/TS 16949:2009 that will need to undergo a transition audit to the International Automotive Task Force (IATF) international...
Ryan E. Day's picture
Ryan E. Day
What do cocoa, socks, and smartphones have in common? If you guessed risk of slavery in the manufacturing supply chain, you are correct. Does your organization have an international supply chain?...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
Our August 11, 2017, episode of QDL looked at the role of technology in after-market service, stairs that help you up, Fidget Cubes, and more. “Climbing Stairs Just Got Easier With Energy-Recycling...
William A. Levinson's picture
William A. Levinson
Joseph Juran once warned1 that ISO 9001 standardizes mediocrity, and users often discover that it does not deliver outstanding or world-class results. This is not because of any inherent problems...
Sal Lucido's picture
Sal Lucido
Automated process management systems are the workhorses of every modern company. These systems guide operations and improve quality and efficiency. Hidden away in the core of each automated process...
Mike Richman's picture
Mike Richman
The dog days of summer are here, but the Aug. 4, 2017, episode of QDL offered lots of cool content. Let’s take a closer look: “What Went Wrong With the F-35?” One expert calls the Lockheed Martin’s...
DNV GL's picture
DNV GL
Bribery and corruption are a $1 trillion drain on the global economy and a door-shutting event for companies unable to prevent rogue acts from destroying a company’s entire reputation. If you think...
AssurX's picture
AssurX
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top...
Elizabeth Gasiorowski Denis's picture
Elizabeth Gasiorowski Denis
Change is nothing new. Nobel laureate Bob Dylan sang that “the times they are a-changin’” back in 1964. The difference today is the pace of change. In his book, Thank You for Being Late: An...
Scott Gottlieb's picture
Scott Gottlieb
It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers...
Pam Bethune's picture
Pam Bethune
Every company is in business to take risks. Every action or failure to take action by that company naturally has some form of risk inherent in the process. To survive, a company needs to...
Claire McCluskie's picture
Claire McCluskie
With ISO 13485:2016—“Medical devices—Quality management systems—Requirements for regulatory purposes” published and being implemented, many medical device customers are experiencing some...