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Timothy Woodcome
An integrated management system (IMS) combines multiple management system standards to which an organization is registered. The management systems are developed, implemented, and maintained via one system with processes that cover each standard’s requirements.
For example, the processes required…
Harry Hertz
Yes, it’s time for the Oxford English Dictionary (OED) to pay attention! Having recently seen an article in The Guardian about the new additions to the OED, it seemed a good time to take a somewhat tongue-in-cheek look at the 10 words I would propose for inclusion in that venerable reference for…
Electronic temperature compensation has been successfully applied to shop-floor gauges for more than 25 years. It’s become a mature technology and proven to be one of the most easily cost-justified means to achieve gauge correlation and eliminate the most common cause of high-resolution gauge…
Karleen Bacoccini
This month, the International Automotive Task Force (IATF) published IATF 16949, the standard for automotive quality management systems. In this article I’ll provide background on the origins of this important industry standard, summarize the key changes from its predecessor, ISO/TS 16949, and…
Christine Schaefer
To entertain you, to grab your attention, and (of course) to advance your understanding of the Baldrige Excellence Framework, staff members who contribute to this blog have occasionally written some odd posts—or, at least, given them curious titles.
In case you’ve missed one or more of these, I’m…
During the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D-printed medical products, ranging from regulatory to IP concerns. Some of these have been quite alarming…
Kade Moody
Is the following statement true or false? The new revenue recognition standard will have only a minimal effect on my accounting practices and policies. I hope that statement is true for your organization, but I think for many healthcare systems, the answer is false.
If you have already started…
Peter Bussey
Operational risk management (ORM) centers on environmental, health, and safety (EHS) risks that can cause accidents or incidents anywhere that work takes place, whether it’s a manufacturing plant, an offshore drilling platform, a mine, or a marine terminal. This article will discuss why and how…
NQA
For companies that are registered to more than one management system, integrating them makes a lot of sense. Combining your management systems provides greater benefit than running separate management systems in parallel. An integrated management system (IMS) can help reduce duplication and…
Christine Schaefer
Every year a new cohort of Baldrige Executive Fellows gains intensive knowledge about leading organizations to excellence through cross-sector, peer-to-peer learning hosted at the sites of Baldrige Award recipients. Every Baldrige Fellow completes a capstone project as part of the executive…
Chad Kymal
Deadlines for ISO 9001:2015 and ISO 14001:2015 registration have appeared on the horizon. Although we have 24 months to get registered to these new standards, some related timelines are looming even closer, notably scheduling a recertification or surveillance audit.
Some organizations have…
Kate Remley
If you’ve ever used a device that picks up signals over the air, you know that sometimes you just can’t get the signal to come in clearly. You point the device every which way, move it all around the room, do a little dance, but nothing seems to work. There doesn’t seem to be any explanation.…
Dawn Bailey
Public schools across the country are facing significant challenges. Lisa Muller, assistant superintendent for Baldrige Award recipient Jenks Public Schools, says schools are dealing with an increase in student needs, while at the same time managing declining revenues and attempting to prepare…
Timothy Lozier
Current management regulations and standards stress the importance of making quality management a higher priority throughout all areas of operation. At Verse Solutions, we wanted to find out how quality managers are adjusting to that new mindset, and how they are using quality-based technology to…
William A. Levinson
Clause 6.1 of ISO 9001:2015 requires “Actions to address risks and opportunities” first with regard to section 4.1, “Understanding the organization and its context” and second in section 4.2, “Understanding the needs and expectations of interested parties.” As 4.2 goes on to say, the latter are…
Daniel Desilets
Sponsored content
Y our product or service is only as good as the management system that supports it. Certification by an independent third-party certification body, such as Intertek, confirms that your management system complies with the respective international standards for quality,…
NIST
NIST scientists have devised and modeled a unique optical method of sorting microscopic and nanoscopic particles by size, with a resolution as fine as 1 nm for particles of similar composition.
A stream of particles of various sizes enters the system at a single point, but the particles exit the…
Swapnil Srivastav
Mandatory reporting requirements for regulations such as Europe’s REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) and RoHS (Restriction of Hazardous Substances) legislation have increased the focus on environmental compliance and ethical sourcing across the globe.…
InfinityQS
What do you feel when you imagine your next regulatory audit? Stress? Anxiety? Overwhelming dread? The average recall can cost a manufacturer as much as $10 million, making compliance important to your brand as well as your bottom line.
As you manage the daily ins and outs of your quality…
James Warren
Creating a new material has long been either an accident or a matter of trial and error. Steel, for instance, was developed over hundreds of years by people who didn’t know why what they were doing worked (or didn’t work). Generations of blacksmiths observed that iron forged in charcoal was…
British Assessment Bureau BAB
There are hundreds of security breaches that happen every day but in the end, they fall into three main groups: malicious, intentional, or criminal; system glitches; and human error.
The IBM “2015 Cost of Security Breach Survey” conducted by Ponemon Research, catalogs 49 percent of the breaches…
Thinh Nguyen, Rachel E. Sherman
One question that product sponsors often ask the U.S. Food and Drug Administration (FDA) is whether their medical product will be regulated as a drug, a device, a biologic, or as a combination product—and in the case of the latter, which FDA component will regulate it.
One way sponsors may…
Jon Speer
Did you know that during the first six months of 2015, 69 percent of 510(k) submissions were rejected the first time? And that up to 75 percent of first-time 510(k) submissions are regularly sent back? I heard this and thought it was a crazy statistic. Is it really that high?
Then I spoke with a…
NIST
A new publication from the National Institute of Standards and Technology (NIST) provides a basic model aimed at helping researchers better understand the internet of things (IoT) and its security challenges.
Examples of IoT systems include a smart electric grid, a home controlled by sensors,…
Jennifer Huergo
As I peer into the cardboard box NIST researcher Amanda Forster holds out for me, I can’t help thinking that this mild-mannered materials scientist has an impressive collection of shivs.
Forster’s collection of handmade prison weapons include a ballpoint pen with a razor embedded in the shaft and…
