Standards Features

Taran March @ Quality Digest's picture
Taran March @ Quality Digest
As manufacturing becomes increasingly oblivious of where one country stops and another begins, the responsibilities of quality managers have extended beyond the safely measurable and into the...
Chad Kymal's picture
Chad Kymal
What is enterprise quality? Simply put, it is a system where there is one quality manual, and a core of common processes, work instructions, and forms and checklists for a multisite environment....
Ryan E. Day's picture
Ryan E. Day
Sponsored Content My wife and I purchased a new car this year. The employee handling the closing paperwork gave a compelling presentation concerning the extended warranty, which we also purchased....
David Sefcik's picture
David Sefcik
Believe it or not, I love to grocery shop. Besides getting to pick all my favorite foods, I love the challenge of getting the best deals—and a challenge it can sometimes be. Without a doubt, I have...
Inderjit Arora's picture
Inderjit Arora
Risk-based thinking can be considered the fundamental change in ISO 9001:2015. Compared to ISO 9001:2008, where preventive action (PA) held a spot in the “act” phase of the plan, do, check,...
Mike Richman's picture
Mike Richman
The March 24 episode of QDL offered a potpourri of topics, including news and features from the realms of academia, corporate culture, and politics. Here’s a quick recap: “Winners Selected for the...
Joseph Aldy's picture
Joseph Aldy
President Trump jettisoned more than 30 years of bipartisan regulatory policy on Jan. 30, 2017, when he issued an executive order on “Reducing Regulation and Controlling Regulatory Costs.” The...
DNV GL's picture
DNV GL
“You should prioritize agility, but find ways to take risks without sacrificing sound execution that can jeopardize both customer satisfaction and, more importantly, safety.” —PWC “2016 Auto...
Mika Javanainen's picture
Mika Javanainen
The September 2018 certification deadline for ISO 9001:2015 is looming. The updated standard promises to further streamline mission-critical tasks and information flows as well as better align...
Bert Coursey's picture
Bert Coursey
Marie Curie is perhaps the most famous woman of 20th-century science. Major films and best-selling biographies have chronicled her discovery of the radioactive elements polonium and radium, for...
Tom Middleton's picture
Tom Middleton
Just inside the entrance to Thomas Edison’s winter home in Naples, Florida, is a bronze bust of Edison himself. The base of the sculpture reads: “There is a way to do it better—find it.” As an...
AssurX's picture
AssurX
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape. In December 2016, Director Janet Woodcock laid out some of the...
Christine Schaefer's picture
Christine Schaefer
Last month, 2001 Baldrige Award-winning University of Wisconsin-Stout hosted a lively campus engagement session. (See for yourself via this video of the live-streamed event, which kicked off with...
DNV GL's picture
DNV GL
More than a million organizations around the world embrace the ISO 9001 quality management system (QMS) standard to guide their businesses and operate in the most efficient manner possible. The...
Pam Bethune's picture
Pam Bethune
One of the newest parts of ISO 9001:2015 and related management standards are the concepts of context and interested parties. What do these mean, and how can you apply them to your organization?...
Mary McAtee's picture
Mary McAtee
Sponsored Content Technical and commercial media sources are constantly discussing how design safety and security has not kept pace with quickly evolving technologies. Pundits are pointing to...
Tim Lozier's picture
Tim Lozier
Sponsored Content For quality management to be effective, a solid corrective action process is critical. ISO standards and general best-practice guides suggest—and even mandate—a set procedure and...
DNV GL's picture
DNV GL
According the International Organization of Standardization (ISO), there are more than 300,000 certifications to ISO 14001 in 171 countries around the world, making it the most relied-upon symbol...
Katherine Watts's picture
Katherine Watts
While at the National MACRA MIPS/APM Summit in Washington, D.C., I heard much discussion centered on how to create and implement strategies that pay physicians fairly, while controlling...
Dara Corrigan's picture
Dara Corrigan
For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this...