All Features
Grant Ramaley
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent. A recent report published by the European Commission found that two out of 11 notified bodies were performing so inadequately,…
NIST
When it comes to detectors for dangerous chemicals, toxins, or nefarious germs, smaller and faster is better. But size and speed must still allow for accuracy, especially when measurements by different instruments must give the same result.
The recent publication of a new standard—a culmination…
Arun Hariharan
Taiichi Ohno, the father of the Toyota Production System, once said, “Where there is no standard [process], there can be no kaizen [improvement].”
In an earlier column, I wrote about how we used the customer-output-process-input-supplier (COPIS) method, which is a customer-first or an outside-in…
LRQA Business Assurance
As ISO/FDIS 55001—“Asset management—Management systems—Requirements” (now in the final draft international standard stage) moves toward its formal publication around the end of this year, organizations that use and depend on a wide range of assets would benefit from spending some time reviewing…
Quality Digest
Some of the [ISO 9001: 2015] requirements are relatively clear; others are more “euphemisms,” and you don’t know how to react… —James Lamprecht, author of ISO 9000: Preparing for Certification (CRC Press, 1992) and former member of ISO/TC 176
During an Aug, 16, 2013, interview on Quality Digest’s…
Umberto Tunesi
First published Oct. 1, 2013, on the CERM Risk Insights blog. © Umberto Tunesi and CERM Risk Insights.
It isn’t Beethoven’s Fifth Symphony. I wish it were. It’s the committee draft (CD) of ISO 9001:2015, or model No. 5, if you prefer. No connection whatsoever to that lady-loved scent, Chanel No. 5…
Denise Robitaille
As ISO 9001 wends its way through the revision process, there have been dozens of articles, webinars, forums, and discussions anticipating what the final product will look like. Pundits and experts, consultants and gurus are all weighing in on what’s going to happen. The prognosticators have made…
Paul Naysmith
Arecent call with an old colleague from Europe got me wondering about a question that few are conscious of: Who is the customer of your quality document? Oh boy, did we have an interesting discussion about quality systems.
My friend was developing and reinvigorating his employer’s quality system,…
Dawn Bailey
A recent article in The Washington Post, “Company Town’s Decline Reflects New Mantra: Shareholders First,” got me thinking. The article begins with a look at Endicott, New York, where, during the 1980s, 10,000 IBM workers kept the upstate town thriving. Today, after years of layoffs and jobs…
Miriam Boudreaux
If your company is ISO-certified or thinking about becoming so, you may already know that meeting customer requirements and achieving customer satisfaction is paramount to the certification. However, it’s not always clear who should be in charge of determining whether customer satisfaction has been…
Umberto Tunesi
Stone Age men, so the story goes, got the wheel inspiration by observing trees rolling downhill. So they sliced trees and fit the rounds they got to their sleds, to move them faster and with less effort. In so doing, they also invented carts while expediting transportation.
But friction’s thermal…
Jerry Wilson
There are many reasons why organizations decide to register or certify themselves to the various standards and specifications in industry; all are important, but not all are vital. Standards registration in support of sales, marketing, and PR efforts certainly helps companies grow, for example.…
ISO
Asset management is not a new practice. Managing assets to meet organizational or social objectives has existed since humans first began building infrastructures, whether private or public. The effort and resources involved inevitably generated the need to preserve and maintain such…
James Lamprecht
The words “risk” or “risks” have been sprinkled throughout the 2015 revision of ISO 9001, the quality management system standard from the International Organization for Standardization (ISO).
Although some “requirements” will be easy to satisfy using well-established process monitoring or…
NIST
Scientists at the National Institute of Standards and Technology (NIST) have developed a new standard reference material (SRM), the first such measurement tool to enable hospitals to link important tissue density measurements made by CAT scans to international standards.
Computed tomography (CT…
Denise Robitaille
What’s Happening With ISO 9001? Stakeholders have offered suggestions for the upcoming revision
Committee Draft of ISO 9001 Is OutChanges include genuine improvement; some will make implementation more difficult
Denise Robitaille
Editor’s note: Denise Robitaille is a member of the U.S. TAG to ISO/TC 176, the committee responsible for updating the ISO 9000 family of standards. She will be reporting on the revision progress to ISO 9001, which will be completed in 2015. Read other articles in the series here.
The first…
Stacey Jarrett Wagner
Approximately half of the 704 employers participating in a survey by The Chronicle of Higher Education and American Public Media’s Marketplace said they have trouble finding qualified college graduates to fill their companies’ positions. Yet, 68 percent of the survey’s manufacturers said colleges…
Michael Ray Fincher
For me, a quality professional with 20 years experience in manufacturing—producing everything from garbage bags to luxury ski boats—my transition to the service industry was a shocking experience to say the least. It was not without challenges, I must confess.
When I was asked to join the…
Bull Wranglers
There are more than 1,100 textbooks referring to “short-term process capability,” as distinct from “long term.” Surely 1,100 textbooks can’t be wrong? Let’s apply the first Bull Wrangler test. Does short- and long-term process capability make common sense?
What is capability?
According to ISO…
Denise Robitaille
Editor’s note: Denise Robitaille is a member of the U.S. TAG to ISO/TC 176, the committee responsible for updating the ISO 9000 family of standards. She will be reporting on the revision progress to ISO 9001, which will be completed in 2015. Read other articles in the series here.
By now most…
Quality Digest
On March 28, 2013, the world lost a person whom many consider to be a major contributor to the world of industrial statistics: George E. P. Box. Relatively unknown outside the world of statistics, Box was certainly very well known by those who have studied or practiced industrial statistics.
His…
Oscar Combs
ISO 9001 is much more than a standard. It should be part of a company’s strategic plan rather than something to get certified to because customers require it. The guidelines and quality principles in ISO 9001 are just good business practices.
Throughout my career in quality, I’ve often been amazed…
Randy Dougherty
This article is about accreditation of conformity assessment bodies. Before proceeding further, however, it is important to provide some definitions in order for all of us to have the same understanding of key terms.
The first term is “conformity assessment body” (CAB). According to ISO/IEC 17000…
Mike Micklewright
Got your attention by what seems a bizarre claim? Yes, you can significantly reduce the number of procedures you maintain by converting your ISO 9001 quality management system (QMS) to one that is also certified to the medical device standard ISO 13485 and the aerospace standard AS9100.
I am…