Standards Features

Anonymous's picture
Rick Gould
Well over half the world’s population does not have access to safe sanitation. For many people, this means the indignity and risks that come of having no toilets. The answer, it seems, lies in new...
Jon Speer's picture
Jon Speer
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for...
James J. Kline's picture
James J. Kline
The term “risk-based thinking” (RBT) is familiar to those in the quality profession. This familiarity comes in part from its inclusion in ISO 9001:2015, the International Organization for...
Ryan E. Day's picture
Ryan E. Day
In the article, “ANSI’s Role in the Wide World of Standards,” (Quality Digest, March 12, 2019), we looked at where standards originate and how companies are involved in developing them. In this...
Ronda Culbertson's picture
Ronda Culbertson
The AS9100 family of standards has completed very important updates, raising the business management quality bar again for aerospace and defense suppliers and OEMs. The transition to the new...
Harry Hertz's picture
Harry Hertz
Recently I’ve seen some startling statistics from Gallup and Glassdoor about employee and customer engagement. I hope those statistics do not represent data from any organization you or I associate...
Alexandra Killewald's picture
Alexandra Killewald
Almost 70 percent of American mothers with children younger than 18 work for pay, but motherhood remains disruptive for many women’s work lives. American women earn almost 20 percent less per hour...
Brian S. Smith's picture
Brian S. Smith
Throughout my career, I have been a member of several trade organizations. I believe that standards have meaning, in every field. When I become a member of an organization, I endeavor to learn as...
Ryan E. Day's picture
Ryan E. Day
According to the International Labor Organization, around the world every day 7,600 people die from work-related accidents or diseases—that’s more than 2.78 million people every year. To address the...
Tom Taormina's picture
Tom Taormina
Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes...
Chad Kymal's picture
Chad Kymal
When we think about IT security, we typically think about the large hacks that were reported in the press. When viewed as a whole, we can understand the magnitude of lost data. It’s no surprise that...
Jon Speer's picture
Jon Speer
You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food...
Ryan E. Day's picture
Ryan E. Day
I love standards, and whether you know it, you love standards, too. For example, let’s say a bulb in your lamp goes bad. You drive down to the local hardware store, buy a bulb, come back home, change...
Donald J. Wheeler's picture
Donald J. Wheeler
Managers the world over want to know if things are “in control.” This usually is taken to mean that the process is producing 100-percent conforming product, and to this end an emphasis is placed upon...
William A. Levinson's picture
William A. Levinson
The Pareto principle calls for focus on the vital few rather than the trivial many. While none of ISO 9001’s clauses are trivial—a nonconformance for any of them requires corrective action—ISO 9001...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety...
Laurel Thoennes @ Quality Digest's picture
Laurel Thoennes @ Quality Digest
Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business? 1988: Food and Drug...
Graham Freeman's picture
Graham Freeman
Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated...
Wendy White's picture
Wendy White
Starting a new facility in the food-processing industry is an enormous undertaking. There are thousands of things that must be accomplished, from hiring and training new staff to ordering and...
Richard Harpster's picture
Richard Harpster
On Oct. 13, 2018, the Automotive Industry Action Group (AIAG) sponsored a webinar on the status of the AIAG Core Tools Software (AIAG CTS). John Cachat, AIAG project manager for the AIAG CTS project...