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Are You Wearing ISO 9001’s Risk-Based Thinking Cap?
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…
The Secret Foundation of Statistical Inference
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…
Fundamental Constants: The Latest—and the Last?
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…
So Why Is It Called ‘Regression,’ Anyway?
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…
IBM Leverages ISO 14001 for Sustainable Business
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,…
Work Systems and Supply Chains: Are You Ready in Case of Disaster?
Dawn Bailey
I heard the example that best helped me understand work systems and supply chains at a Baldrige training event right after the very sad 2011 earthquake and tsunami in Japan. A colleague was talking about automakers in the United States and elsewhere whose suppliers were located in the devastated…
Benchmarking Risk and Compliance: How Do You Add Up?
Timothy Lozier
Compliance is a broad term. It can mean compliance to financial obligations, quality and safety, or general compliance to any regulation that is driving the organization. When you look at the current state of quality management and safety management with respect to compliance, most of the…
‘Retained Document Information’ in ISO 9001:2015
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…
What Comes After Teaching Leadership?
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…
Your Employees: A Principal Factor in the Supply-Chain Risk Equation
Sonal Sinha
In a recent poll, employees (22.9%) were identified as the top source of supply chain fraud risk, followed by vendors (17.4%) and other third parties (20.1%), including subcontractors and their vendors. In calling new attention to the old cliché of “an inside job,” the statistics may prove to be…
Failure Analysis
Fred Schenkelberg
Why do so many avoid confronting the reality of failure? In plant asset management, we are surrounded by people who steadfastly don’t want to know about nor talk about failures. Yet failure does happen; let’s not ignore this simple fact. The blame game Unlike a murder mystery, failure analysis (…
Using ISO Management Systems Standards to Develop Effective Supplier Partnerships
Randall D’Amico
Sponsored Content 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…
Shewhart and the Probability Approach
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…
The Value of the Baldrige Criteria to Manufacturers
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…
Kaizen Approach to ISO 9001:2015
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…
Discovering the ‘S’ in CSR
Quality Digest
Born in Bulawayo, Zimbabwe, and raised in Cape Town, South Africa, Wayne Visser, Ph.D. is, as CSRWire USA says, “. . . one of the most prolific, creative, and original thought leaders on corporate social responsibility.” That begs a question, however—should we use the term “social” or “sustainable…
Implementing ISO 9001, ISO 14001, and ISO 45001
Chad Kymal
The outward focus of an organization comes from defining the context, mission, vision, policies, and interested-party expectations. A company’s goals and objectives provide the lens through which this outward focus can be seen (figure 1). Setting the strategic direction An organization uses its…
Data-Driven Decision Making
Akhilesh Gulati
The big data revolution is requiring a seismic shift inside organizations, both in the way we build relationships and the way we make decisions. Each is now driven by data rather than intuition. In general, decision making is accomplished via a thought process of selecting a logical choice from…
Certifying Body: Partner or Police Force?
Arun Hariharan
In my previous article, “Is Poor Quality ISO 9001’s Fault?” I shared the example of the chairman of a large company who ridiculed ISO 9001, saying, “Even the municipal office of this city is ISO 9001-certified. And we all know how bad the municipality is. I don’t believe ISO 9001 can do my…
Is Poor Quality ISO 9001’s Fault?
Arun Hariharan
The chairman of a large company once ridiculed ISO 9001, saying, “Even the municipal office of this city is ISO 9001-certified, and we all know how bad the municipality is. I don’t believe ISO 9001 can do my business any good.” The chairman had similar uncharitable things to say about other…
A Risk Management Primer
Tim Lozier
Sponsored Content We’ve all heard it before: Change is the only constant. This isn’t just cliché but a truth that all companies will come to recognize. Change is the driving force behind improvement. And all of the changes that take place within an organization, whether to products, processes, or…
Three Benefits of ISO 9001 Certification for Small Businesses
Gurdeep Mahal
Sponsored Content One of the most common misconceptions about ISO 9001 certification is that it’s only for big businesses. This couldn’t be further from the truth. The standards set forth by ISO are generic by design so that they may be applied to businesses of any size, type, and product line. As…
Pushing the Frontier of Risk Assessment and CAPA
Mary McAtee
  Technology is evolving more rapidly than at any point in history. We tend to think of seminal moments in history, such as the inventions of the steam engine or powered flight, as literal moments in time. The reality is that the invention of the steamboat by Robert Fulton was only possible…
Mission, Vision, and Values Come First
Dawn Bailey
As a writer for the Baldrige Program, I have a lot of fun learning about how various people and organizations use the Baldrige Excellence Framework to guide, focus, and improve their operations. I recently had the pleasure of conversing with Shannon Block, the president and CEO of the Denver Zoo…
ISO 9001:2015 and Enterprise Information Management
Mika Javanainen
The recently released final draft of the ISO 9001:2015 standard for quality management systems has now been voted on by members of both the ISO and CEN standards bodies. The latest version still targets the same goal—to help organizations improve overall performance—while addressing the profound…

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