July 16, 2021
By David Jensen, Staff Writer, MasterControl
Five years ago, the International Organization for Standardization (ISO) published the ISO 13485:2016 standard. This post addresses the most common questions industry stakeholders have asked about the standard and its current status.
May 20, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Extrapolating the root cause of a quality problem isn’t the same as determining the problem’s real cause. Learn how to discern real causes and avoid the cycle of recurring root cause investigations.
December 5, 2017
By Michelle Lott, Principal and Founder, Lean RAQA
Manufacturers everywhere have been waiting a year and a half for additional guidance on the requirements of ISO 13485:2016, hoping September’s release of the "ISO 13485:2016 – A Practical Guide" (hereafter known as the “Practical Guide” or “Guide”) would bring the “practical” guidance promised.
