The U.S. Food and Drug Administration (FDA) has announced a Town Hall on April 1, 2026, to explain how inspections of medical device manufacturers will change under its new Quality Management System Regulation (QMSR), with a focus on a risk-based approach.
The U.S. Food and Drug Administration (FDA) has updated how it inspects medical device manufacturers, introducing a lifecycle‑based approach to quality management system oversight under its new Quality Management System Regulation.
The American National Standards Institute (ANSI) is inviting experienced automation professionals to consider leadership roles in the U.S. Technical Advisory Group (TAG) to ISO/TC 184/SC 4, which contributes to international standards for automation systems and industrial data.
The National Institute of Standards and Technology (NIST) has launched an AI Agent Standards Initiative to address security, identity, and interoperability challenges as AI agents become more widely used.
The U.S. Food and Drug Administration (FDA) has released new guidance to help companies comply with its Food Traceability Rule, clarifying how the requirements apply across the food supply chain.
Two U.S. health care organizations have been selected to receive the 2025 Malcolm Baldrige National Quality Award, the nation’s only presidential honor for performance excellence.
The SQF Institute has announced six finalists for its 2026 SQF Excellence Awards, recognizing professionals who advance food safety through auditing and site leadership under the Safe Quality Food program.
Zaire Garcia has won the Ninth Annual Terry Burgess Assessor of the Year Award from the ANSI National Accreditation Board (ANAB) for his leadership in assessments and strong commitment to mentoring others.
The ANSI National Accreditation Board (ANAB) is inviting nominations for two national committees that oversee personnel certification and certificate accreditation.
The Association of Food and Drug Officials (AFDO), a nonprofit association focused on food safety and regulatory collaboration, offers a national Retail HACCP Plan Review Service to help streamline approvals of specialized food processes.
The U.S. Food and Drug Administration (FDA) has replaced its long-standing Quality System Regulation (QSR) with the new Quality Management System Regulation (QMSR), changing the legal framework for quality management in the U.S. medical device sector.
The International Organization for Standardization (ISO) has advanced the revision of ISO 19011 to the Final Draft International Standard (FDIS) stage.
The International Medical Device Regulators Forum (IMDRF) has published a playbook to help regulators use shared approaches when reviewing medical devices, known as regulatory reliance.
The German Institute for Standardization (DIN) has published DIN SPEC 92006, introducing the first unified framework for artificial intelligence (AI) testing tools and setting clear requirements for how these tools should be designed and used.
The Organisation for Economic Co-operation and Development (OECD) has released a report examining how governments can improve regulation by making better use of standards, measurement, and assurance systems, known as quality infrastructure (QI).
The revision of ISO 9000, the international standard that defines the basic concepts and vocabulary of quality management, has reached the Final Draft International Standard (FDIS) stage, the final step before publication.
A new international standards committee has been created to develop standards for digital product passports (DPPs), systems designed to share key product information across the entire lifecycle and improve transparency and circular economy practices.
Global Accreditation Cooperation Incorporated has launched its new official website, providing a central online platform for the organization that became the single global body for international accreditation cooperation.