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Are Your Audits Clause-Based or Risk-Based?

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I’ve observed that ISO management system audits have remained largely unchanged, even after the advent of ISO 19011:2018, the auditing standard that superseded ISO 19011:2011.

Deep Underground, Robotic Teamwork Saves the Day

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When a Manhattan parking garage collapsed in April 2023, rescuers were reluctant to stay in the damaged building, fearing further danger.

Improving Safety with a Computerized Maintenance Management System

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In the quickly changing industrial landscape, firms continue to place a high premium on safety. Innovative approaches to improving industrial safety have been made possible by technological advancements.

What Is Risk Analytics?

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Risk analytics is a vital component of risk management that uses statistical models, data analysis, and predictive modeling techniques to assess, quantify, and mitigate risks in various domains.

What FDA QSR and ISO 13485 Harmonization Means

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Photo by Piron Guillaume on Unsplash

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On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR).

Stop Going It Alone

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Photo by Thomas Bonometti on Unsplash
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History is filled with tales of courageous and decisive heroes. Individuals like Julius Caesar and Winston Churchill, for example, have led from the front to guide people through adversity and achieve ultimate success.

Five Necessary Steps to Maintain a Reliable CAPA Process

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Since 2010, citations for insufficient corrective action and preventive action (CAPA) procedures have been at the top of the list of the most common issues within the U.S.

Fifteen Questions to Ask QMS Software Vendors in the Medical Device Industry

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Credit: National Cancer Institute on Unsplash

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Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).

The CEO’s New Strategy

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Photo by Paweł Furman on Unsplash
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Not many years ago, there was a CEO so exceedingly fond of finding the right strategy that he spent all of his money on consultants to tell him what the strategy should be.

Linking Design Controls and Risk Management in the QMS

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Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.

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