Auditing the Climate Change Additions to ISO Management System Standards – An Auditor’s Approach

Bob Deysher – Senior Consultant, Quality Systems/Risk Management/Auditing Member Bodies in the London Declaration have amended over 30 of ISO’s Management System Standards, including ISO 9001. As amendments they are not considered revisions; there is no transition period. “[U]pon publication, certification bodies should include the new text in their auditing or the organization and its […]

FDA Final Rule Harmonizes Medical Device Quality System Regulation with International Standard

Angelo Scangas – CEO & Chief Customer Officer The FDA’s Quality Management System Regulation (QMSR) update represents a significant move towards harmonizing the Quality System Regulation (QSR) for medical devices with the international standard ISO 13485:2016. This harmonization aims to streamline regulatory requirements, ease the burden on device manufacturers, and ensure consistent safety and effectiveness […]

Aligning ISO 13485 and FDA QSR 21 CFR 820 for Medical Devices

Introduction: The US Food and Drug Administration (FDA) has proposed a new framework that would harmonize its medical device quality management system (QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard. This draft would align the Quality System Regulation (QSR) with requirements for medical device manufacturers and with quality system requirements in […]

QSG Training & Work Instruction Videos

Studies show that reading blocks of text is one of the least efficient methods of transferring knowledge especially with a diverse workforce. With this in mind, the fact that most quality systems are focused on written procedures is an issue. The existence of modern video tools means that it is easy to create visual work […]

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