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Quality Digest
BioCision was founded in 2007 by Rolf Ehrhardt and Brian Schryver when they realized, having spent many years in the clinical and laboratory environment, that there were critical unmet needs in the handling of temperature-sensitive biospecimens and biologics.
The rapid adoption of their first…
Quality Digest
In October 2001, an international team led by Lockheed Martin was awarded the contract to build the next-generation Joint Strike Fighter (JSF) aircraft, which resulted in the development of the F-35 Lightning. The requirements for the new aircraft were complex, demanding new heights of lethality…
Paula Oddy
Organizations pursue registration to international standards for a variety of reasons, but in the broadest possible sense most agree that the goal is to improve business operations and reap financial rewards, either by saving money through increased efficiencies or in making money by getting or…
NIST
At the new NIST Center for Automotive Lightweighting (NCAL), workloads are fraught with stress and strain—all to help the auto industry take a heavy load off future cars and light trucks.
To meet proposed federal fuel-efficiency standards—54.5 miles per gallon by 2025, or nearly double today’s…
Denise Robitaille
Unless you’ve been hiding under a rock for the last two years, you can’t help to have noticed that the ISO 9001 standard is in the middle of its revision process. Seems like people have been talking about this revision for ages. And, it’s not even a whole new standard. They’re not starting from…
Whitney Andrews
Medical device manufacturers are facing mounting pressure to better manage the quality of their supply chain. One approach they’ve taken to improve risk management and increase efficiency is to partner with suppliers who are ISO 13485 certified.
ISO 13485 is an internationally recognized quality…
NIST
Recent experiments have confirmed that a technique developed several years ago at the National Institute of Standards and Technology (NIST) can enable optical microscopes to measure the 3D shape of objects at nanometer-scale resolution—far below the normal resolution limit for optical microscopy (…
Rick Gehrke
The International Labour Organization estimates that more than 2 million deaths every year can be attributed to work activities. This single statistic clearly indicates the pressing need for occupational health and safety regulations, and the importance of a single standard to help organizations…
Gary Phillips
For decades now, the measurement systems analysis (MSA) approach has been the predominant method for evaluating measurement systems capability. Although this method is widely considered to be an acceptable and comprehensive approach throughout most of the world, a growing number of specialized…
Rob Fenn
Arecent client satisfaction survey conducted by our company, the British Assessment Bureau (BAB), a UK-based certification body, highlighted the benefits of achieving certification to ISO 9001. Here is a summary of the results.
As our client base has increased over the years, we have moved the…
Gurdeep Mahal
ISO standards help make the world a safer and more efficient place and help tackle a myriad of societal issues. They also touch almost everything we do. The sparked interest in the new ISO 9001:2015 revision is significant, given that the draft has notable changes vs. the current 2008 version. The…
Christine Schaefer
In the Baldrige Health Care Criteria for Performance Excellence, category three, concerning customer focus, asks how your organization engages its patients and other customers for long-term marketplace success. The related self-assessment questions cover how your organization listens to the voice…
Dawn Bailey
Much has been discussed about the value of tomorrow’s leaders learning about the Baldrige Criteria for Performance Excellence while still in school. As an example, I remember listening to a presentation by Bruce Kintz, president of Concordia Publishing House, a 2011 Baldrige Award recipient, about…
Maria Lazarte
Everyone has a passion, whether it involves biking the toughest roads or collecting Star Wars figurines. Mine is travel.
My love of travel has taken me far and wide. I have been thrown into a river by an elephant in Malaysia and attended a four-day traditional wedding in Sudan. I have swum with…
Dan Nelson
Editor's note: This is part two of a series about customer-centric quality management systems. Read part one here.
Bob’s Machine Shop has been satisfying customers with good parts delivered on time for more than 20 years. Bob has satisfying customers down pat—it doesn’t happen day in and day out…
NIST
Particles of soot floating through the air and comets hurtling through space have at least one thing in common: 0.36. That, reports a research group at the National Institute of Standards and Technology (NIST), is the measure of how dense they will get under normal conditions, and it’s a value…
Christine Schaefer
How is a company to decide whether to use the Baldrige Criteria for Performance Excellence, the ISO 9001 quality management system, or both? To explore some key distinctions between the comprehensive business model provided by the Baldrige framework and the quality management system provided by…
Umberto Tunesi
In my August 2013 column titled “Beethoven’s Fifth and ISO 9001:2015,” I commented on the ISO 9001 Committee Draft (CD). As is typical of me, I wasn’t soft. Now the interim draft international standard (DIS) is available for voting on by ISO members, and I’d like to offer my opinion about this…
Jeffrey Eves
ISO 14001 is the world’s best-known environmental management system standard, and it provides a systematic framework to help organizations protect the environment through balanced socio-economic means.
In conjunction with an updated ISO 9001, a new version of ISO 14001 is being released in the…
Miriam Boudreaux
Sometimes interpreting ISO 9001 or API Q1/API Q2 requirements seems to force us to agree to things we won’t be able to do, or to sustain for more than a few months, let alone days. So how do we write our policies and procedures to explain our approach while avoiding being boxed in by our own words…
David Lawson
Story update 6/18/2014: In an earlier version of this article the editors changed ISO/DIS 9001:2014 to ISO/DIS 9001:2015. The error was ours, not the author's. The correct name of the document is ISO/DIS 9001:2014, as now shown.
The publication of the draft international standard (DIS) of the…
Dan Nelson
Editor's note: This is part one of a serios about customer-centric quality management systems. Read part two here.
A document review is supposed to be conducted as part of stage one of the ISO certification process. For the uninitiated looking into certification—maybe you—that statement often…
Michael A. Hughes
Your quality management system (QMS) documents for AS9100, ISO 9001 or any other standard for that matter, do not have to be complicated. Why create volumes of wordy procedures that employees will probably never read? And even if they do, they certainly won’t understand.
As auditors and quality…
Kelly Kuchinski
Editor’s note: A webinar on this topic will held on May 29, 2014, at 2:00 p.m. Eastern / 11:00 a.m. Pacific. Register here.
Food and beverage manufacturers have seen a considerable number of changes over the last decade. Mergers and acquisitions have expanded the footprint of many food and beverage…
Mark Schmit
ISO 9001 has been the quality management standard, with almost a million businesses certified around the world. It has been through many revisions, in 1994, 2000, and 2008, but the 2015 revision has an added element to consider—risk.
ISO international standards help to ensure that products and…
