All Features
NIST
They activate airbags. Keep aircraft correctly positioned in flight. Detect earthquakes or sudden vibrations in failing machinery. Guide military hardware. Monitor falls in elderly individuals and initiate calls for help. They rotate the display on a smartphone from vertical to horizontal, and…
Jon Speer
If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date. Let me tell you why.
Here’s the definition of “risk management” as defined in ISO 14971:2007—“Medical devices—…
Ken Miller
Please pardon me, but I feel a little like a modern-day Paul Revere alerting you to the start of the second wave of Health Insurance Portability and Accountability (HIPAA) compliance audits.
Last week, Jocelyn Samuels, director of the Health and Human Services’ Office of Civil Rights (OCR),…
NIST
Researchers at the National Institute of Standards and Technology (NIST) have developed the first widely useful standard for magnetic resonance imaging (MRI) of the breast, a method used to identify and monitor breast cancer.
The NIST instrument—a “phantom”—will help standardize MRIs of breast…
Lillian Erickson
The updated version of ISO 9001, published in September 2015, generated much anxiety among companies fearing a bumpy transition to the updated and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.
Despite having quality experts…
NIST
I
n the age-old struggle between humans and microbes, bacteria seem to be regaining the offensive. Only about a dozen classes of chemicals protect us from the myriad pathogens that populate our environment. Numerous agencies have warned that evolved resistance could soon render common antibiotics…
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…
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…
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,…
Stephen Mundwiller
One of the more enjoyable discussions I’ve seen on the Internet recently has to be about what to do with the quality manual. A common question is, “So what do I call this thing I put all the procedures in, now that we can’t have a quality manual?” It’s part of the panic brewing among quality…
Donald J. Wheeler
Here we look at a simple example to discover the commonalties of various data analysis techniques widely used in industry today. Careful consideration of the following may result in insights that were not part of your introductory class in statistics.
Our example uses the gate oxide thicknesses…
Timothy Lozier
There’s been a shift in how companies view quality and compliance, and as a result, businesses are looking for a more comprehensive method for measuring operational efficiency. Risk management processes are proving to be an effective option for this. ISO 9001:2015 now promotes risk-based thinking…
Dawn Bailey
Dorothy: Now which way do we go? Scarecrow: Pardon me, this way is a very nice way. Dorothy: Who said that? Toto barks at the scarecrow. Dorothy: Don’t be silly, Toto. Scarecrows don’t talk. Scarecrow: [points other way] It’s pleasant down that way, too. Dorothy: That’s funny. Wasn’t he pointing…
Mark Esser
The nefarious Major Uncertainty has kidnapped Monsieur Kilogram, putting the world’s measurements of mass in jeopardy. As the world spirals into “Mass Hysteria,” the remaining SI Superheroes, champions of the metric system, leap into action to save the day, and hopefully Monsieur Kilogram as well…
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…
NIST
Let’s say you’re a biotechnologist working to develop new medicines or a better test for forensic analysis. You might find yourself frequently using absorbance spectroscopy, a technique that allows researchers to identify even small amounts of a substance (such as DNA) or an antibody based on how…
Mark Esser
Maintaining a social media account involves keeping track of the many random celebrations that can provide an excuse to post a story that otherwise might not have a timely hook. National Peanut Butter Day (Jan. 24 for the uninitiated) is just such a day.
While NIST chemist Carolyn Burdette spent…
Kevin McKinley
Walking the snowy streets of the small Swiss town of Davos, it was impressive to know that 40 heads of state and 2,500 leaders from business and society were there to talk about some of the most important global challenges facing us today.
In the main congress hall, I saw and met leading…
Chad Kymal
ISO 9001:2015, ISO 14001:2015, and ISO 45001:2015 establish clear expectations for top management. Not only are executives accountable for the effectiveness of these respective systems, they also have specific tasks ranging from establishing objectives to supporting relevant managers in their…
Lawrence Livermore National Laboratory
Although the most common method of metal 3D printing is growing exponentially, moving forward from producing prototypes to manufacturing critical parts will be possible only by reaching a fundamental understanding of the complex physics behind the process, according to a new paper written by…
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…
NIST
Flu season typically peaks between December and February, but by the time the winter holidays roll around, many of us will have already waited in line at area clinics, grocery stores, and pharmacies to get our annual flu shot. The Centers for Disease Control reports that U.S. vaccination efforts…
Miriam Boudreaux
Before 2015, many of us rode one of the largest waves of success in the history of the oil and gas industry. Everything was booming—companies, salaries, bonuses, cities, services, etc. Then 2015 came and crashed the party, leaving us all a bit uncertain.
Now, entering 2016, you may have some your…
Christine Schaefer
A question for devotees of the Baldrige Excellence Framework: Do people who passionately promote continuous improvement within organizations also tend to make New Year’s resolutions to improve their own well-being?
Seriously, I’m wondering if those who fully appreciate the framework’s value in…
Grant Ramaley
On Dec. 23, 2015, a vote was taken among 78 nations with accreditation bodies that are part of the International Accreditation Forum (IAF). From the vote it was determined that a new international database for quality management system (QMS) certifications should be created.
The intent of the…
