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Workplace Safety Standards: ISO 45001

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According to the International Labor Organization, around the world every day 7,600 people die from work-related accidents or diseases—that’s more than 2.78 million people every year.

The Perils of Outsourcing: A Case Study

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Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes was limited to a few sentences in the standard’s clause 4.1.

Information Security: To Hack, or Not to Be Hacked

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When we think about IT security, we typically think about the large hacks that were reported in the press. When viewed as a whole, we can understand the magnitude of lost data.

ANSI’s Role in the Wide World of Standards

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I love standards, and whether you know it, you love standards, too. For example, let’s say a bulb in your lamp goes bad. You drive down to the local hardware store, buy a bulb, come back home, change out the bulb, plug the lamp back in, and... it lights up.

Design Robust Processes to Avoid ISO 9001:2015 Nonconformances

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Your audits don’t have to feel like this.
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The Pareto principle calls for focus on the vital few rather than the trivial many.

Taking a Risk-Based Approach to Drug Inspections

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As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.

FDA Milestones

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Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?

Proactive Processes in High-Reliability Organizations

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Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated.

The Do’s and Don’ts of Preparing a New Facility for the First Audit

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Starting a new facility in the food-processing industry is an enormous undertaking. There are thousands of things that must be accomplished, from hiring and training new staff to ordering and installing equipment.

Inside Quality Digest Live for December 21, 2018

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We tied up last year in a neat little bow, talking about how stories define ourselves and our work; waste is waste, no matter your political leanings; and putting numbers from the news in context.

Pagination

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