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Implementing ISO 9001, ISO 14001, and ISO 45001
Chad Kymal
The outward focus of an organization comes from defining the context, mission, vision, policies, and interested-party expectations. A company’s goals and objectives provide the lens through which this outward focus can be seen (figure 1). Setting the strategic direction An organization uses its…
Certifying Body: Partner or Police Force?
Arun Hariharan
In my previous article, “Is Poor Quality ISO 9001’s Fault?” I shared the example of the chairman of a large company who ridiculed ISO 9001, saying, “Even the municipal office of this city is ISO 9001-certified. And we all know how bad the municipality is. I don’t believe ISO 9001 can do my…
Is Poor Quality ISO 9001’s Fault?
Arun Hariharan
The chairman of a large company once ridiculed ISO 9001, saying, “Even the municipal office of this city is ISO 9001-certified, and we all know how bad the municipality is. I don’t believe ISO 9001 can do my business any good.” The chairman had similar uncharitable things to say about other…
A Risk Management Primer
Tim Lozier
Sponsored Content We’ve all heard it before: Change is the only constant. This isn’t just cliché but a truth that all companies will come to recognize. Change is the driving force behind improvement. And all of the changes that take place within an organization, whether to products, processes, or…
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…
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…

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