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How ISO 9001:2015 Helps Improve Customer Relationships
John Nolan
The ultimate aim of ISO 9001:2015 is to enable businesses to satisfy their customers effectively. You could say that all the standard’s clauses help to provide your customer with a consistent and rewarding experience from your goods or services, but ISO 9001:2015 actually deals with “customer…
Health Plan Member Satisfaction Climbs
J.D. Power and Associates
According to the recently released J.D. Power 2016 Member Health Plan Study, critical factors of health plan member satisfaction are highest in areas of the country that have more competition between different health plans. On a nationwide basis, member satisfaction with their health plans has…
Brain Imaging Triggers Marketing Breakthroughs
Hilke Plassmann
The holy grail of marketing—a universal predictor of customer behavior—may be closer than ever, thanks to recent advances in the field of neuromarketing. Even at its best, traditional market research has built-in limitations. First of all, consumers may be biased or unwilling to reveal their true…
A Surgeon’s View of Data-Driven Quality Improvement
Eston Martz
There’s plenty of noisy disagreement about the state of healthcare, but when you look beyond the controversies, a great deal of common ground exists. Many agree that the way we’ve been doing things is wasteful and inefficient, when healthcare should be delivered as efficiently and effectively as…
NIST Method May Find Elusive Flaws in Medical Implants and Spacecraft
NIST
Medical implants and spacecraft can suddenly go dead, often for the same reason: cracks in ceramic capacitors, which are devices that store electric charge in electronic circuits. These cracks, at first harmless and often hidden, can start conducting electricity, depleting batteries or shorting…
Why ISO 13485:2003 Is Important
ISO
With medical devices ranging from simple needles to life-saving high-tech implants, ensuring the highest possible level of safety is one of the industry’s greatest priorities. Here, as the chair of the ISO technical committee for quality management and related general aspects for medical devices,…
Volume and Value in Healthcare Models
Katherine Watts
Bundled payments. Volume-to-value. Cost accounting. Process improvement. Patient engagement. Population health. Organizational leadership. These are more than just the newest industry buzzwords: They’re the trends that will compel the healthcare industry to transform its business model. They will…
Are You Losing Opportunities for Improvement?
Arun Hariharan
The other day, I visited a retail outlet of a wireless services provider to get information about its international roaming packages. The company has a few thousand outlets nationwide; they’re called “relationship centers” staffed with half a dozen employees who try to up-sell products and…
Pinpointing the User Experience
Knowledge at Wharton
Today, design has a seat at the table. With the success of products like the iPod and the iPhone, businesses have realized that a good user experience is key for improving the bottom line. Yet even with this determined focus on design, most digital experiences fall short of user expectations. Of…
How B2B Companies Become Customer Experience Leaders
Annette Franz
When I go to customer experience conferences, B2B companies are underrepresented, both in attendees and speakers. When clients look for benchmark data, B2B reports are few and far between. These are just two examples of why I want to revisit a question I posed in a post I wrote two years ago: If…
The Center for Biologics Evaluation Keeps Biological Product Standards High
Peter Marks
Part of the vision of the Center for Biologics Evaluation and Research (CBER) is to strengthen the center as the preeminent regulatory organization for biologics. One way CBER is achieving this is through the work of the Office of Compliance and Biologics Quality (OCBQ) and the Office of Vaccines…
Retailers Compared, Lower Satisfaction Results
American Customer Satisfaction Index ACSI
Two years removed from its all-time high, customer satisfaction with the retail trade sector fell for a second consecutive year, sliding 2.6 percent to an ACSI score of 74.8. Despite the decline for 2015, the overall score for retail stands almost exactly at its long-term average (74.6). A closer…
What Do They Care About Keeping Customers?
Annette Franz
The perils of focusing on customer acquisition and sales over customer experience and retention can be summed up nicely with this: “As fast as you’re bringing customers in the front door, they’re running out the back door.” Some refer to it as the leaky bucket syndrome. If only companies knew…
Successful Digital Transformation Starts With the Customer
Joerg Niessing
I’ve noticed that many companies are using the trendy term “digital transformation” without fully understanding what it means. Leveraging digital technology to make organizational processes and offerings more efficient may increase profit margins in the short term. But a true digital…
FDA Proposes Cybersecurity Guidelines for Medical Devices
Ken Miller
I wrote last month about the need to increase security for imaging devices in hospitals. The devices I cited store both personal and medical information about patients and should be subject to standard security measures. Very often they are not. Last month the U.S. Food and Drug Administration (…
Modernizing Pharmaceutical Manufacturing to Improve Drug Quality
The U.S. Food and Drug Administration (FDA) is working with drugmakers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective—with an eye toward avoiding drug shortages. When manufacturing problems…
Creating a Culture of Innovation in Your Healthcare Organization
James Brewton
The healthcare industry is under pressure to improve performance across strategic measures of performance, including delivery cost, operating revenue, employee engagement, patient safety, patient experience, and patient outcomes. A growing number of organizations turn to innovation as a way to…
Are Quality Bonuses Right for Your Medical Directors?
Greg Anderson
A s the market gradually moves toward value-based reimbursement, hospital payments to physicians have also been in transition from purely productivity-based pay to incentives based in part on quality, patient experience, and efficiency of care. This shift has taken place in employment,…
How to Prepare for an FDA Inspection
Jon Speer
During the past several years, the FDA has been more aggressive and active in performing medical device company inspections. This has led to a far greater number of companies receiving Form 483 warning letters and citations. FDA Form 483s are a good way for your medical device company to flush $…
Six Surefire Ways to Insult Your Customers
Kevin Cundiff
Ask how you can help, always keep a smile, respond to requests promptly... the list goes on. You’ve probably been exposed to an abundance of tips and tricks about how to become more customer-friendly. That kind of advice can definitely be valuable, but what you likely don’t hear—unless you’re a…
What Technology Can and Can’t Do for Quality
Arun Hariharan
Technology is a useful tool in quality. That said, there are limits to what technology can do. Here’s my summary of its advantages and disadvantages for quality professionals. 1. Data and measurements. Technology can help you automate measurements and analysis of data (Minitab statistical software…
MDSAP Reaches for a 2019 Deadline in Canada
Grant Ramaley
The International Medical Device Regulators Forum (IMDRF) began a pilot phase for its new Medical Device Single Audit Program (MDSAP) in January 2014. This audit combines regulatory audits the manufacturer would typically face when they sell their products in certain IMDRF member countries: the…
Desired Outcomes Matter
Annette Franz
What happens when we really understand our customers’ desired outcomes or the jobs they are trying to do? Something pretty incredible. A few weeks ago I wrote about “Faster Horses... and Customer Outcomes” and the importance of asking the right questions to understand desired outcomes in order to…
Will You Be Ready for a FSMA Audit?
Brandon Henning
Although the FDA’s Food Safety Modernization Act (FSMA) was passed in 2011, the reality is that the rules that went along with the law—and that truly define how it will be executed and regulated—are just now being finalized. Enforcement of these rules should really ramp up in 2016 and 2017. Will…
Process Excellence Makes Sales Problems Solvable
Michael Webb
This month Quality Digest Daily welcomes Michael Webb, a noted author and consultant who writes about how the quality and productivity sciences improve sales and marketing departments. How well does your company benefit from quality improvement and productivity? For instance, how well do you…

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