Frances Brunelle
Just as baby boomers on the manufacturing plant floor are getting ready to retire, so are the owners. More than 5,000 small manufacturing operations (with annual revenues between $2 and $20 million)...
Anjalika Singh
Management system implementation reminds me of the advice my gym instructor gave when I first enrolled at my local health club: “Losing weight doesn’t happen in one day and with crash diets,” he said...
Inderjit Arora
Every company uses a system to understand the requirements and inputs of its customers, and then plans to deliver outputs meeting those requirements as a conforming product or service. The...
Paul Foster
When Deloitte wanted to get people excited about employee training, the company decided to adopt a gamification strategy for its online training portal. Using elements like achievement badges,...
Jon Speer
Medical device manufacturers must implement and maintain a quality management system to ensure they are producing safe and effective medical devices. Created and maintained by the International...
Eric Weisbrod
In manufacturing, standardization in production and process control leads to increased profitability and cuts down on many siloed problems that can plague even the most quality-focused organization....
William A. Levinson
The martial arts rank, Shodan, for a first-degree black belt, does not mean “expert”; it means “first step.” ISO 9001:2015 is similarly a valuable and vital first step toward world-class performance...
Jennifer Lopez
Globalization of the medical device market as well as its supporting supply chains continues to increase year after year. This has forced regulatory bodies to grapple with finding a way to narrow the...
ISO
Innovation isn’t just about having a few bright ideas. It’s about creating value and helping organizations continuously adapt and evolve. ISO is developing a new series of International Standards on...
Stephanie McArdle
The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.
The ASR program originally launched in...
Grant Ramaley
Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1...
Chad Kymal
During the early 1980s, GM, Ford, and Chrysler established the Automotive Industry Action Group (AIAG), a not-for-profit organization with the mission “To improve its members’ competitiveness through...
Jyoti Madhusoodanan
A frog the size of a fingernail. A poncho-clad farmer leading his mule. A tree, some intertwining leaves, a silhouetted figure holding a pot. Such logos are stamped on labels of coffee, cocoa,...
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
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
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
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
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
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
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...
