Standards
Integrating environmental, health, and safety (EHS) with quality management is no longer optional for manufacturers; it’s essential for achieving operational excellence, ensuring ISO compliance, and driving sustainable growth. Traditionally, EHS management and quality management systems (QMS)…
Data are the backbone of our digital world. From healthcare to finance, and from government agencies to private businesses, organizations everywhere rely on vast amounts of data to function effectively.
It’s not just businesses that generate data. We all leave digital trails…
When you go to a medical appointment, does the doctor look at you while you talk? Or are they busy typing everything you say into a computer? If it’s the latter, you may find that will change soon, thanks to artificial intelligence.
Some doctors’ offices are using AI services to…
In recent months, through several of my professional activities, a recurring and increasingly concerning pattern has emerged: The use of AI to generate client responses to accreditation assessment findings (nonconformities) as well as participant essays, exercises, and examination answers from…
During a June 2025 webinar on pragmatic AI applications in healthcare quality management and regulatory affairs, live polling of quality and regulatory professionals revealed that approximately 80% of respondents were actively implementing AI solutions or seriously considering their use in…
The medical device industry is counting down to an important deadline: On Feb. 2, 2026, the U.S. Food and Drug Administration’s new Quality Management System Regulation (QMSR) formally replaces the Quality System Regulation (QSR).
Although the full text of the QMSR has been…