Industrial organizations face numerous compliance regulations such as management system certification, information security, corporate social responsibility compliance, and limiting the content of hazardous substances in products.

As the universe of quality management systems expands, it’s interesting to observe the increasing variables that constitute the concept of applicability. Let’s take maintenance of records as an example.

In Part I, “Savvy Compliance Strategy Can Improve GMP,” we took a high-level look at a process for automating regulatory compliance managem

The Bre-X gold scandal that rocked the Toronto Stock Exchange (TSX) during the late 1990s forever changed the Canadian mining sector. When millions in pension dollars were lost due to fraudulent and falsified test data, investors around the world were outraged.

There is no shortage of standards. There are standards that define how something should be made vs. those related to processes, such as ISO 9001.

Approximately three-fourths of product safety recalls in the United States are the result of some design flaw in the product rather than a manufacturing or other defect. Most violations of the U.S.

The billowing cloud of volcanic ash spewing from Iceland may have been a major pain for air travel, but it also had a positive side. It served up a gentle reminder for me to find out what the heck is going on with AS9100 certification.

Almost two years ago, the management team of the Indiana Toll Road (ITR Concession Co. LLC) and the Chicago Skyway Bridge (Skyway Concession Co.

The following is a profile of one of the 2009 Malcolm Baldrige National Quality Award Winners. The Baldrige Award is the nation’s highest award for quality and is administered by the Department of Commerce through the National Institute of Standards and Technology.

ISO 9001 makes multiple references to the need to understand customer requirements and to monitor the extent to which those requirements have been fulfilled.