All Features
Rob Fenn
So, you’ve decided that you really need to embark upon ISO 9001 registration. Perhaps it’s being requested by a client, or you’ve worked at a company before that had implemented it to great effect. Or maybe you’ve just been convinced by the numerous studies that have elucidated the strong benefits…
Shimadzu
International standards ISO 6892 and JIS Z2241 for tensile testing of metallic materials have been revised with the addition of another test item: strain rate control.
When strain is measured with an extensometer, strain rate control has been added as a test item to the current stress rate…
Dan Nelson
Nobody likes to be told they’re doing something wrong. But if you were doing something wrong due to a misunderstanding, and it was actually hindering your operations while adding unnecessary cost, wouldn’t you want to know?
For example, let’s assume that you are using a tool consistently with…
Dan Nelson
Based on a reading of the ISO 9001:2015 Committee Draft (CD), the 2015 standard will further clarify and emphasize the requirement to apply a process approach. Although the requirement has been resident in the standard since 2000, this fundamental requirement has been overlooked often enough to…
Gurdeep Mahal
According to a report from the London-based Centre for Economics and Business Research, a dollar invested in improving an organization’s approach to quality management results in a six-fold return in increased revenues, and a 16-fold reduction in expenses. The promise of dramatic improvements is…
Ryan E. Day
It’s a funny spot I find myself in. I’ve been very vocal within Quality Digest about the need for, and virtues of, innovation as it pertains to our company. Very vocal. So much so, that the bosses have put me in a position to cash the checks my mouth has been writing.
I’ve written about…
Chris Carson, Lindsey Waddell, Marilyn Platt, Steve Holladay
Companies with mature management systems often feel a decrease in value and an increase in cost over time due to third-party audits. Advanced Surveillance and Recertification Procedures (ASRP) is a solution that shows demonstrated cost reductions in external audit frequency, but has also increased…
Ryan E. Day
‘We call them unscheduled (vs. surprise) audits, in that they are not part of the originally planned, annual first-party audit plan.”
“We sometimes need to have unscheduled audits, but they are normally not intended as surprise audits. The auditor may agree with the auditee on an unscheduled…
Mary McAtee
It was the end of a long day. While sitting over dirty martinis with extra olives, my long-time colleague, Tisha Tomlinson, and I were discussing a situation and trying to plan a strategy that met the needs of all involved. We had spent the day with various quality and environmental, health, and…
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
