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The Case Against the AIAG-VDA DFMEA
Richard Harpster
Richard Harpster's op-ed is in response to a recent Quality Digest article and webinar discussing the benefits of the draft AIAG-VDA FMEA Handbook. As he points out at the end of this article, the AIAG has provided a means to solicit comments, pro or con, on the handbook. We encourage interested…
Fresh Changes in the Pipeline
ISO
Ageing wastewater systems are under threat from growing populations, urbanization, pollution. and climate change, not to mention human behavior. However, despite these challenges and fears for health and safety, the new ISO 24516 series is playing a key role in turning what many consider a burden…
The Importance of Documenting Enterprise QMS Process Requirements
Eric Cooper
You’re in the market to build a new house. Would you tell the builder what you’re looking for, or would you just tell him to build “something?” If the latter, what’s the likelihood that the house you end up with is going to be what you want? Documenting your requirements should be obvious, right…
ISO 9001:2015 and ISO 10018: Developing People Engagement In a QMS
Bruce Bolger
HighlightsThe New Focus on People Overview of ISO 9001:2015 Standards and the ISO 10018 Certification How This Microsite Helps Quality Management, Auditors, and Solution Providers Articles ResourcesOther Articles In This Series This Month's Featured ArticleAccumold Starts With the Why  Can the…
Inside Quality Digest Live for Jan. 19, 2018
Mike Richman
During last Friday’s episode of Quality Digest Live, we looked at the far-reaching implications of a prospective merger, previewed our latest webinar with DNV, considered the importance of fun at work, and inspected some interesting stereo microscopes from Vision Engineering. Here’s a closer look…
Five Key Standards Trends to Watch in 2018
Miriam Boudreaux
If you are a manufacturing company or a service provider, there is a good chance that you have heard about standards such as ISO 9001. In fact, you may already be certified. But whether you are certified or not, read on for some of the expected trends in the world of standards and certification…
Transitioning to ISO 45001
Ismael Belmarez
Workplace safety is a vital concern for every organization. According to the U.S. Bureau of Labor Statistics, 2.9 million nonfatal workplace injuries and illnesses were reported by private industry employers in 2016, costing employers tens of billions of dollars. In March of this year, the leading…
Inside Quality Digest Live for Jan. 12, 2018
Dirk Dusharme @ Quality Digest
Our Jan. 12, 2018, episode of QDL looked at smart manufacturing, remanufacturing, pants-on-fire bosses, and five things your QMS needs. “Impatient With Colleges, Employers Design Their Own Courses” Microsoft, Amazon, and others are teaming up with third-party online courseware providers to…
The Test of Time: NIST’s Wall of Many Stones
Jason Stoughton
Frequented by more deer than people, the NIST stone test wall lives a fairly isolated existence. Out among the trees and the grass on the south end of the Gaithersburg, Maryland, campus, it cuts an imposing and visually bizarre figure. Set in the mortar of its technicolor face are more than 2,000…
Top 10 Things You Need to Know About Implementing Risk-Based Thinking
Richard Harpster
The concept of risk-based thinking has been implicit in previous editions of ISO 9001 through requirements planning, review, and improvement. But ISO 9001:2015 requires companies to use risk-based thinking to manage their business. If you want to implement an ISO 9001:2015-compliant quality…
Inside Quality Digest Live for Dec. 15, 2017
Mike Richman
Last Friday’s episode of QDL was our final show of the year, and we’re leaving 2017 on a high note! We brought you two great interviews and a terrific Tech Corner, not to mention some advice on increasing your productivity in 2018. Let’s take a look: “AIAG and VDA Release Draft of Harmonized FMEA…
AIAG and VDA Release Draft of Harmonized FMEA Manual
Chad Kymal, Gregory F. Gruska
The Automotive Industry Action Group (AIAG) and the German Association of the Automotive Industry, or VDA (Verband der Automobilindustrie), have been cooperating in automotive quality management systems since the advent of the second edition of ISO/TS 16949 in 2002. The integration work that…
Inside Quality Digest Live for Dec. 8, 2017
Dirk Dusharme @ Quality Digest
Our Dec. 8, 2017, episode of QDL looked at smart manufacturing, remanufacturing, pants-on-fire bosses, and five things your QMS needs. “Smart Manufacturing Trends in 2017” The digital manufacturing environment, or smart manufacturing, is growing by leaps and bounds, and is spurred on by…
DNV GL Healthcare and CoxHealth Partnership for Improvement
Patrick Horine
Readmission of patients within 30 days of discharge is one of the most serious issues plaguing healthcare delivery in the United States. No one wants to go to the hospital, let alone return shortly after being discharged; readmissions also hurt hospital bottom lines. Readmissions cost hospitals $…
Gain a Competitive Advantage Through ISO Certification
Jorge A. Correa
Sponsored Content To be competitive on both a national and a global level, organizations must adopt a forward-thinking approach in developing their management strategies. One of the foundations of a successful strategy is the management system, which may be well-defined and documented, or consist…
Inside Quality Digest Live for Dec. 1, 2017
Mike Richman
During last Friday’s episode of QDL, we examined the potential of quality thinking to improve outcomes for people’s health, manufacturing, and workplace efficiency. Let’s take a look: “World Toilet Day” ISO truly has a standard (or at least a standard in development) for everything. World Toilet…
The New Arsenal of Risk Management
ISO
A new version of ISO 31000:2009—“Risk management” is due to be unveiled early next year. As the threat of risks grows for governments, organizations, and the public alike, how can the new, streamlined standard help to make our future more secure? Ten years ago, the boardrooms of banks and…
What a Risk-Based QMS Means
Jon Speer
What exactly is a risk-based quality management system (QMS)? This is a timely topic to get into. In 2016, ISO 13485—“Medical devices”—“Quality management systems” was updated, and one of the key concepts presented is the idea of a risk-based QMS. Historically, regulations have almost exclusively…
MDSAP’s Final Pilot Report: A Glass 10% Full
Grant Ramaley
I have written previously about the Medical Device Single Audit Program (MDSAP) created by the International Medical Device Regulators Forum (IMDRF). MDSAP is viewed as a single audit covering the United States, Canada, Brazil, Australia, and Japan. The intent was to establish one medical-device…
Inside Quality Digest Live for Nov. 10, 2017
Mike Richman
QDL co-host Dirk Dusharme was on vacation for our Nov. 10, 2017, episode, but we ably covered for his absence with some thought-provoking stories and great guests. Let’s take a look: “What Really Causes Workplace Stress” A multidisciplinary team of researchers at the University of Southern…
ISO 10018 Certification for People Management Is Launched
ICEE
Reflecting a greater focus on achieving organizational success through people, the first certification program for ISO 10018, “Quality management—Guidelines on people involvement and competence” is now available for organizations committed to quality people management. This standard was created in…
Aerospace Faces Challenges as Market Rapidly Expands
Gene Morrison
Never-before-seen growth has turned the aviation, space, and defense industries into lucrative markets. Demand for increased efficiency, security, quality, and durability has taken off in recent years, resulting in high margins and operating profits. With exponential growth potential and a long-…
Inside Quality Digest Live for Nov. 3, 2017
Mike Richman
During the Nov. 3, 2017, episode of QDL, we (figuratively) traveled the globe to bring you quality information. Let’s take a closer look: “‘Made in Japan’ Falls from Grace Amid Scandals, Systematic Flaws in Manufacturing Industry” Kobe Steel is the latest Japanese manufacturer to admit to…
Understanding New GM Layered Process Audit Requirements in IATF 16949
Eric Stoop
General Motors (GM) recently published updated customer-specific requirements for IATF 16949 compliance. The new requirements take effect Nov. 1, 2017, and cover layered process audit (LPA) requirements in greater depth than previous versions. LPAs use a series of frequent audits to check high-…
Benefits of Accredited Conformity Assessment and the Supply Chain
Sheronda Jeffries, Carmine Reda
Companies purchase lots of things. They purchase tangible goods, like raw materials and equipment, or intangible services, like calibration and transportation. And most companies have basic criteria that they use to qualify and select suppliers. Many companies require their suppliers to obtain…

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