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Three Benefits of ISO 9001 Certification for Small Businesses
Gurdeep Mahal
Sponsored Content One of the most common misconceptions about ISO 9001 certification is that it’s only for big businesses. This couldn’t be further from the truth. The standards set forth by ISO are generic by design so that they may be applied to businesses of any size, type, and product line. As…
Pushing the Frontier of Risk Assessment and CAPA
Mary McAtee
  Technology is evolving more rapidly than at any point in history. We tend to think of seminal moments in history, such as the inventions of the steam engine or powered flight, as literal moments in time. The reality is that the invention of the steamboat by Robert Fulton was only possible…
Mission, Vision, and Values Come First
Dawn Bailey
As a writer for the Baldrige Program, I have a lot of fun learning about how various people and organizations use the Baldrige Excellence Framework to guide, focus, and improve their operations. I recently had the pleasure of conversing with Shannon Block, the president and CEO of the Denver Zoo…
ISO 9001:2015 and Enterprise Information Management
Mika Javanainen
The recently released final draft of the ISO 9001:2015 standard for quality management systems has now been voted on by members of both the ISO and CEN standards bodies. The latest version still targets the same goal—to help organizations improve overall performance—while addressing the profound…
Europe Signs Multilateral Recognition Arrangement for ISO 13485
Grant Ramaley
The European Cooperation for Accreditation (EA), an association of national accreditation bodies in Europe, has implemented the accreditation requirements of the International Accreditation Forum (IAF) and has signed up for the IAF Multilateral Recognition Arrangement (MLA) extension to cover ISO…
What’s Really Cool About ISO 9001:2015
Denise Robitaille
OK, so “cool” probably isn't the precise term—unless you happen to be a standards uber-geek. But there are definitely some enhancements to the 2015 revision of ISO 9001 that are worth getting a little excited about. The final draft international standard (FDIS) is finally out for ballot, so most…
The Best Time to Plant a Tree…
Ryan E. Day
Sponsored Content With the ISO 9001:2015 revision currently dominating standards conversations, it's easy to pass over the humble energy standard from Geneva—ISO 50001. You might not even know what it is, let alone the benefits of implementing it. On the other hand, the rising price of energy and…
How Exposure Affects Risk
William A. Levinson
The requirement for risk-based thinking is among the most significant changes in ISO 9001:2015. Army Techniques Publication (ATP) 5-19, Risk Management is a public domain reference that supports this requirement. ATP 5-19 includes a risk assessment approach that is similar to failure mode and…
Risk-Based Thinking and ISO 9001:2015
Chad Kymal, R. Dan Reid
Sponsored Content Risk is not a straightforward concept. Definitions of risk vary, even within documents published by the International Organizations for Standardization (ISO). One ISO definition indicates that risk is the “effect of uncertainty on an expected result.” Risk is now addressed by…
Reviewing the U.S. Office of Personnel Management Data Breach
Yo Delmar
In June 2015, it was initially reported that the U.S. Office of Personnel Management (OPM) experienced a massive data breach, potentially affecting as many as 4 million current and former federal employees. Updated reports indicate that the actual number of people compromised is more than five…
What’s Really New in ISO 9001:2015? Knowledge Management
Arun Hariharan
Peter Drucker once said, "The most important, and indeed the truly unique, contribution of management in the 20th century was the fifty-fold increase in the productivity of the manual worker in manufacturing. The most important contribution management needs to make in the 21st century is similarly…
ISO 9001:2015: Avoiding Nonconformities During the Transition
Randall D’Amico
Story update 8/6/2015: Paragraph 14 of this article stated "many organizations are ill-equipped to develop an effective risk management assessment process," implying, to some, that a risk management system is required, which as stated in paragraph 8 of this article, it is not (nor was that the…
Developing a Product Liability Program
Randall Goodden
E very year in the United States, an estimated 80,000 product liability lawsuits are filed, and thousands of products recalled—and that’s happening to companies with certified quality programs in place. In 2014 alone, some of the highest fines were imposed by government agencies because…
How to Delegate Effectively and Minimize the Risk
Jesse Lyn Stoner
Delegating is often one of the hardest things for a manager to do. You give away your authority to make decisions but are still responsible for the outcome if something goes wrong. Often managers don’t delegate because they hold one or more of these beliefs. Do any sound familiar? “If you want…
ISO 9001:2015’s Customer Requirements
Mary McAtee
Everyone is gearing up for the challenge of updating their compliance to the requirements of the 2015 version of ISO 9001. Most quality professionals I speak with seem to have digested the new requirements as something very different than past versions. Personally, I don’t see it in quite the same…
Systematic Handling of Organizational Knowledge
Ulrich Wegner
The new ISO 9001, scheduled for publication in late 2015, introduces the term “knowledge.” As knowledge was not addressed by the previous version of ISO 9001, the depth of this topic and the approach to it are new. The international standard ISO/DIS 9001:2015—“Quality management systems—…
Six Missteps on the Way to Sustainable Risk Management
Marc Dominus, Douglas Montgomery
The key challenge for risk professionals is no longer how to establish an enterprise risk management (ERM) program, but how to sustain its effectiveness. Often, ERM programs get off to a great start but soon lose their momentum because of certain missteps that occur. Misstep 1: Assuming that the…
People, Process, and Plentiful Passion
Harry Hertz
Every year, I return from the Baldrige Program’s Quest for Excellence Conference energized and full of pride in the success that can be achieved by people working together. And every year, I try to synthesize what I’ve heard into some key themes that reflect the best practices of the United States…
Rational Subgrouping
Donald J. Wheeler
While the computations for a process behavior chart are completely general and very robust, the secret to using a process behavior chart effectively lies in the art of rational sampling and rational subgrouping. Rational subgrouping has to do with organizing your data so that the chart will answer…
Using an Integrated Management System to Implement ISO 9001:2015
Chad Kymal
The final draft international standard (FDIS) of ISO 9001:2015 will be released in July, and the revised standard is slated for publication in September. Per Annex SL of the “Consolidated ISO Supplement,” some elements of the standard will be restructured to allow for easier integration of…
Change and Risk-Based Thinking
William A. Levinson
Management of change is a safety-related phrase from the chemical process industry that is adaptable to risk-based thinking. The basic premise is that anything new, different, or nonroutine (such as repairs or replacement of equipment, and process startups) creates a safety risk. This principle…
Effective Complaint Management
Richard DeRisio
Editor’s note: Quality Digest will present Richard DeRisio’s webinar, “Effective Strategies for Complaint Handling” on May 19, 2015, at 2 p.m. Eastern, 11 a.m. Pacific. DeRisio will be a guest on Quality Digest Live on Friday, May 15, also at 2 p.m. Eastern, 11 a.m. Pacific, to preview the webinar…
Potential Risks of ISO/DIS 9001:2015 to the Oil and Gas Industry
Bud Weightman
The fifth edition of ISO 9001, which is slated for publication in late 2015, has some good ideas regarding improvement and harmonization with other management system standards such as ISO 14001. However, ISO/Draft International Standard (DIS) 9001:2015 has taken away prescriptive language for a…
Leading the Way Toward Standardized Auditing
Nicola Wilson
With quality the driving force behind innovation and operational improvements in the vast majority of organizations, it’s no surprise that every industry sector has embraced it, from manufacturing to the service. For some sectors, however, quality improvements can be the difference between life…
Mitigating Supplier Risk Through Cloud-Based Quality Management Portals
Benjamin Mack
Suppliers play a major role in bringing products to market. This means that the product received from suppliers must be safe and of the highest possible quality, which is a must because stakeholders not only rely on their suppliers to help bring products to market—they also rely on them to help…

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