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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…
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…
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…
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—…
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…
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…
‘Values Are Really the Culture of Our Organization’
Christine Schaefer
During the recent leadership plenary of the Baldrige Program’s Quest for Excellence Conference, senior leaders of the 2014 Baldrige Award recipients shared their insights and lessons learned. Scott McIntyre, the U.S. leader of PricewaterhouseCoopers’ (PwC) Public Sector Practice, said, “If we’re…
RIP, Quality Manual
Strahinja Stojanovic
A quality manual will not be a mandatory document for a quality management system (QMS), according to the available version of the ISO/DIS 9001:2015 standard. How did that happen? The quality manual was one of the first documents that a certification body asked for before the certification audit.…
Benefits of Certification
Calin Moldovean
Management systems programs such as ISO 9001 and ISO 14001 were originally implemented to help organizations gain market access, satisfy mandatory customer requirements, streamline processes, manage growth, drive continual improvement, and generally keep up with the competition. In today’s…
Using the Baldrige Criteria for a More Effective Job Search
Dawn Bailey
I am grateful for the opportunity to work for the Baldrige Program. We’re blessed with an engaged community of Baldrige practitioners—folks who have served as examiners at all levels, across the country. These practitioners not only understand but have often mastered how to use the Baldrige…
A Memorable Quest for Excellence Moment
Harry Hertz
Before you read further, get your tissues out. I’ve had many memorable moments over the years at Quest for Excellence conferences. And I’ve never left an annual conference without some immediate action items and feeling inspired that excellence is achievable in every type of organization. But…
Deming’s 14 Points and Their Influence on ISO/FDIS 9001, Part 2
Peter Theobald
In part one of this two-part article, I began an evaluation of Deming’s 14 points, and how they influenced the final draft international standard (FDIS) version of ISO 9001:2015. Part one provided an overview of Deming’s first seven points; in this continuation we explore points eight through 14…
Addressing Requirements for Global Workplace Health and Safety
The U.S. Department of Labor estimates that 2.2 million workers worldwide lose their lives each year due to workplace-related accidents, injuries, and diseases, and that another 4.1 million workers in the United States suffer serious work-related illnesses or injury. These and other sobering…
Meeting the Requirements of ISO 9001:2015
Timothy Lozier
The ISO 9001:2015 standard may still be in draft form, not quite set to replace the existing standard until the end of 2015, but it’s important to keep apprised of these changes and what they will mean for you when complying with the new standard. So what changes lie ahead? In this article we’ll…
Risk Management in ISO 9001 and ISO 14001
Paula Oddy, Jeffrey Eves
In the years since ISO 9001 and ISO 14001 were first published, many organizations have followed the models of these standards in designing their own management systems. However, many of those systems haven’t been utilized to effectively manage risk. Many have been minimally developed to meet…

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