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Your Transition to IATF 16949: Five Critical Things to Think About Right Now
Mark Whitworth
For 17 years, ISO/TS 16949 was the leading standard for quality system requirements in the automotive industry. The technical specification was jointly developed by the International Automotive Task Force (IATF) and the International Organization for Standardization (ISO) in 1999. In October 2016…
ISO 9001:2015—Three Steps to a Smooth Transition
Timothy Woodcome
Sponsored Content If your organization has yet to make the transition from ISO 9001:2008 to ISO 9001:2015, you’re not alone. It’s estimated that less than 20 percent of the more than one million organizations certified globally have made the transition to the latest version of the standard (as of…
ACSI Report on Customer Satisfaction With Banks Shows Rebound
American Customer Satisfaction Index ACSI
(ACSI: Colorado Springs, CO) -- Customer satisfaction with banks is up, according to the American Customer Satisfaction Index (ACSI). Its recent report covers the finance and insurance sector, which includes retail banks, credit unions, health insurance, property and casualty insurance, life…
Considering Human Factors Requirements in ISO 9001 and AS9100
The new revision of AS9100D is now out, and clause 10.2—“Nonconformity and corrective action” will require us to “evaluate the need for action based on human factors to ensure nonconformities do not recur.” In addition, clause 7.1.4 of both ISO 9001:2015 and AS9100D require us to consider human…
Creating a Safety Net for Medical Devices
Suzanne Schwartz
During National Cybersecurity Awareness Month, which took place in October, the public and industry were encouraged to understand the importance of cybersecurity and to be vigilant when it comes to the technology we rely on every day, including helping patients remain confident in the safety of…
Using a Conformity Matrix to Align Processes to ISO 9001:2015
William A. Levinson
Sept. 22, 2018, is the deadline for registration to ISO 9001:2015, and this seems to allow organizations plenty of time to make the transition to the new standard. The good news is that, despite the radical changes to the standard’s structure, the underlying requirements are not particularly…
Four U.S. Organizations Receive Nation’s Highest Honor for Performance Excellence
NIST
The U.S. Commerce Secretary, Penny Pritzker, has named four organizations as the 2016 recipients of the Malcolm Baldrige National Quality Award, the nation’s highest presidential honor for sustainable excellence through visionary leadership, organizational alignment, systemic improvement and…
Inside Quality Digest Live
Mike Richman
Hard as it may be to believe, a close analysis of our extensive trove of behavioral data on the Quality Digest user group indicates that more than a handful of you don’t regularly watch our regular weekly web TV show, Quality Digest Live, which broadcasts from our studio in Northern California…
PPAPs: A Supplier’s View
Cole Cooper
A production part approval process (PPAP) is used by companies to establish confidence and rules in a production process. In a sense, it gives customers a view into their suppliers’ manufacturing capabilities. A PPAP is required when there is a new part, engineering changes, tooling changes,…
Safety and the Gemba Walk
The United State Occupational Safety and Health Administration (OSHA) estimates that $60 billion is lost annually from workplace injuries and illness. Using the administration’s $afety Pays Program calculator, 20 carpal tunnel syndrome injuries will cost a company $1,260,000 in direct and indirect…
Meet Bob, PML’s Second ‘Primary’ Coordinate Measuring Machine
NIST
Until recently, if a company wanted the best measurements in the world for the physical dimensions of one of its dimensional standards, it had to book time on the NIST Physical Measurement Laboratory’s (PML) Moore M48 coordinate measuring machine (CMM). Operating at NIST since 2000, this CMM—…
How Strong Is Your QMS Program?
Michael Causey
It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management processes—especially document management and change control—will be…
ISO 9001:2015 Revision Refresher
Paula Oddy
Changes to the global economy during the last two decades have dramatically altered the landscape of business and industry. Globalization has enabled an ever-lengthening supply chain, which confers greater complexity and risk to every step of the process, whether for material goods or for services…
A Guide for When to Embrace Risk for Value
Dawn Bailey
Should an organization embrace risk or spend millions of dollars a year to avoid it? How do you know when a particular strategy is best? Considerations for such thinking are covered in the Baldrige Excellence Framework, and the topic was recently explored by Brennan McEachran in an Innovation…
What Is an Integrated Management System?
Timothy Woodcome
An integrated management system (IMS) combines multiple management system standards to which an organization is registered. The management systems are developed, implemented, and maintained via one system with processes that cover each standard’s requirements. For example, the processes required…
Heads Up, OED
Harry Hertz
Yes, it’s time for the Oxford English Dictionary (OED) to pay attention! Having recently seen an article in The Guardian about the new additions to the OED, it seemed a good time to take a somewhat tongue-in-cheek look at the 10 words I would propose for inclusion in that venerable reference for…
The Value of Temperature Compensation in Shop-Floor Gauging
Electronic temperature compensation has been successfully applied to shop-floor gauges for more than 25 years. It’s become a mature technology and proven to be one of the most easily cost-justified means to achieve gauge correlation and eliminate the most common cause of high-resolution gauge…
IATF 16949 Released: Preparing for the Transition
Karleen Bacoccini
This month, the International Automotive Task Force (IATF) published IATF 16949, the standard for automotive quality management systems. In this article I’ll provide background on the origins of this important industry standard, summarize the key changes from its predecessor, ISO/TS 16949, and…
What Does That Have to Do With the Baldrige Excellence Framework?
Christine Schaefer
To entertain you, to grab your attention, and (of course) to advance your understanding of the Baldrige Excellence Framework, staff members who contribute to this blog have occasionally written some odd posts—or, at least, given them curious titles. In case you’ve missed one or more of these, I’m…
The Evolving Regulatory Landscape of 3D-Printed Medical Products
During the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D-printed medical products, ranging from regulatory to IP concerns. Some of these have been quite alarming…
Implementing the Converged Healthcare Revenue Recognition Standard
Kade Moody
Is the following statement true or false? The new revenue recognition standard will have only a minimal effect on my accounting practices and policies. I hope that statement is true for your organization, but I think for many healthcare systems, the answer is false. If you have already started…
Three Essential Capabilities for Operational Risk Management
Peter Bussey
Operational risk management (ORM) centers on environmental, health, and safety (EHS) risks that can cause accidents or incidents anywhere that work takes place, whether it’s a manufacturing plant, an offshore drilling platform, a mine, or a marine terminal. This article will discuss why and how…
Where to Begin With Integrated Management System Implementation
NQA
For companies that are registered to more than one management system, integrating them makes a lot of sense. Combining your management systems provides greater benefit than running separate management systems in parallel. An integrated management system (IMS) can help reduce duplication and…
Bringing a Systems Approach to U.S. Population Health
Christine Schaefer
Every year a new cohort of Baldrige Executive Fellows gains intensive knowledge about leading organizations to excellence through cross-sector, peer-to-peer learning hosted at the sites of Baldrige Award recipients. Every Baldrige Fellow completes a capstone project as part of the executive…
ISO 9001:2015 and ISO 14001:2015: Dealing With Deadlines
Chad Kymal
Deadlines for ISO 9001:2015 and ISO 14001:2015 registration have appeared on the horizon. Although we have 24 months to get registered to these new standards, some related timelines are looming even closer, notably scheduling a recertification or surveillance audit. Some organizations have…

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