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By: Ryan E. Day

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By: Mike Richman

The March 24 episode of QDL offered a potpourri of topics, including news and features from the realms of academia, corporate culture, and politics. Here’s a quick recap:

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“You should prioritize agility, but find ways to take risks without sacrificing sound execution that can jeopardize both customer satisfaction and, more importantly, safety.”

—PWC “2016 Auto Industry Trends”

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By: Mika Javanainen

The September 2018 certification deadline for ISO 9001:2015 is looming. The updated standard promises to further streamline mission-critical tasks and information flows as well as better align quality management with overall business management. But to earn certification, organizations must first meet a long list of stringent requirements. For example, they must establish quality objectives, integrate those objectives into business processes, and promote the use of risk-based thinking.

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By: Tom Middleton

Just inside the entrance to Thomas Edison’s winter home in Naples, Florida, is a bronze bust of Edison himself. The base of the sculpture reads: “There is a way to do it better—find it.” As an accredited auditor of management systems and good manufacturing practices (GMPs), I have always seen curiosity as the trait that makes for a successful auditor and a successful audit.

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By: AssurX

Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.

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By: Christine Schaefer

Last month, 2001 Baldrige Award-winning University of Wisconsin-Stout hosted a lively campus engagement session. (See for yourself via this video of the live-streamed event, which kicked off with dancing.) The university holds the “You Said... We Did” sessions each January to demonstrate its responsiveness to the input of its employees and students.

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More than a million organizations around the world embrace the ISO 9001 quality management system (QMS) standard to guide their businesses and operate in the most efficient manner possible. The International Organization for Standardization (ISO) has recently updated ISO 9001 from its 2008 version; the 2015 date assigned to the latest revision reflects the completion of work by the various technical committees that contribute to major updates of ISO standards.

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By: Pam Bethune

One of the newest parts of ISO 9001:2015 and related management standards are the concepts of context and interested parties. What do these mean, and how can you apply them to your organization?

What the standard says

When making sense of Clause 4.1—“Understanding the organization and its context” and Clause 4.2—“Understanding the needs and expectations of interested parties,” we first want to look at what the standard actually says:

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By: Tim Lozier

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For quality management to be effective, a solid corrective action process is critical. ISO standards and general best-practice guides suggest—and even mandate—a set procedure and proper documentation for addressing and correcting issues.

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