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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…
Mike Micklewright
I’ve made the point many times that the quality function and the lean/continuous improvement/kaizen function within an enterprise are really one and the same. Treating them as separate value streams with their own documentation, procedures, and goals is wasteful, short-sighted, and disrespectful…
TÜV SÜD America
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Company managers have a lot on their plates. It’s a tall order to handle daily operations, inventory, staffing needs, training, deadline and quota expectations, and a bevy of other duties. The best managers know enough to delegate certain responsibilities which can help maintain…
Dawn Bailey
Losing can actually have its benefits. For Baldrige users, however, it’s a common saying that everyone is a winner who takes that first step.
The most important reason for using the Baldrige Excellence Framework is not to win an award but to improve financial and business performance, says Joseph…
Christine Schaefer
Being a Baldrige examiner: What is the experience like? Some have compared the work—especially during the final phase of an evaluation—to being in a rigorous MBA program. Others may find it’s like being part of a dispersed but highly engaged task force, as teams collaborate online and on the phone…
Peter Holtmann
The auditing profession is changing. Auditors are getting older. Technology is changing the way auditors work. Companies now work 24/7 around the globe, speaking different languages and integrating different cultures, forcing auditors to adapt to a new work reality. How is all this affecting the…
Craig Cochran
ISO 9001 might be the most confusing document in business history. I first became aware of the standard in the late 1980s when my manager handed it to me and said, “See if you can figure this thing out. Our plant has to get certified.”
I took the document back to my desk and attempted to read it…
Jeffrey Eves
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In 1996, the International Organization for Standardization (ISO) first released the ISO 14000 family of standards, which provided tools for organizations wanting to manage their environmental responsibilities. In the years since, ISO 14001—“Environmental management systems—…
The QA Pharm
Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and Cosmetic Act (FDCA) legal cases that establish that the manager of a corporation can be prosecuted under the…
TÜV SÜD America
As we near the end of 2015, the pilot phase of the International Medical Device Regulators Forum’s (IMDRF) Medical Device Single Audit Program (MDSAP) is approaching its third and final year. In this article, we’ll provide a review of the pilot study’s progress since its inception two years ago,…
Mika Javanainen
With more than one million certifications issued, ISO 9001 is the world’s most widely adopted framework for quality management systems, helping companies achieve conformity of products and services to meet customer expectations and regulatory compliance. The ISO 9001 standard has become synonymous…
Donald J. Wheeler
When industrial classes in statistical techniques began to be taught by those without degrees in statistics it was inevitable that misunderstandings would abound and mythologies would proliferate. One of the things lost along the way was the secret foundation of statistical inference. This article…
NIST
In a world of incessant change, some things have to stay the same. One is the set of values for the fundamental physical constants—such as the speed of light or the charge of the electron—that underlie precision measurements in industry, science, and medicine worldwide.
Yet even the constants…
Patrick Runkel
Did you ever wonder why statistical analyses and concepts often have such weird, cryptic names? One conspiracy theory points to the workings of a secret committee called the International Committee for Sadistic Statistical Nomenclature and Numerophobia (ICSSNN), which was formed solely to befuddle…
ISO
A meaningful, systematic approach to environmental management has made IBM one of the world’s most environmentally conscious companies. The globally integrated IT company leverages ISO 14001 for a comprehensive corporate policy on environmental affairs.
In a recent interview for ISOfocus,…
Craig Cochran
ISO 9001:2015 does a lot of things right, but using clear language isn’t one of them.
One of the most glaring examples is the transformation of the word “records” into “retained documented information.” That's right, the standard’s updaters took one word and turned it into three. And the three…
Harry Hertz
Business schools today have a renewed emphasis on teaching leadership. Dawn Bailey explored this topic in a recent Blogrige post. One of the principles behind this shift, she explained, is intended to cause a deep dive into values. And values-centered leadership is, in my opinion, a critical…
Randall D’Amico
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Relationships between an organization and its suppliers have traditionally been characterized by adversarial activities and posturing in which at least one, and often both, parties lose. Rather than working together to find ways to create a win-win outcome, buyers use their…
Donald J. Wheeler, Henry R. Neave
In theory, there is no difference between theory and practice. In practice, there is. During the past three months we have looked at three families of probability models and found that they share some remarkable properties. These properties provide a theoretical explanation of how and why process…
Christine Schaefer
In early 1989, Michael Whisman, MBA, MBB, was trained by his then-employer, Baxter Healthcare, to be an examiner within the company’s newly announced Baxter Quality Award. To determine award winners for the performance recognition program, the company was using the first edition of the Criteria…
Mike Micklewright
Finally... the new version of ISO 9001:2015 has been released. I can hear many of you screaming, “Hurray!” Or not. More realistically, I’m sure many of you living in the kaizen world are thinking, “Yeah, so what? This stuff has nothing to do with real kaizen, and in fact, it often creates…