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FDA Schedules Town Hall On Risk Based Inspections Under New QMSR Framework
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.
FDA Shifts Medical Device Inspections To Lifecycle-Based QMS Oversight
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.
ANSI Invites Experts To Lead U.S. TAG For Automation Standards
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.
NIST Launches AI Agent Standards Initiative To Address Security And Interoperability
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.
FDA Issues New Guidance On Food Traceability Rule
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.
NIST Announces 2025 Baldrige National Quality Award Recipients
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.
SQF Institute Names Finalists for 2026 Excellence Awards
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.
ANSI And BSB Introduce ANSI Bharat Compliance Platform For Indian Market
The American National Standards Institute (ANSI) and BSB Edge, a compliance technology company serving regulated industries in India,
Zaire Garcia Wins Terry Burgess Assessor of the Year Award
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.
ANAB Seeks National Experts For Personnel Credentialing Committees
The ANSI National Accreditation Board (ANAB) is inviting nominations for two national committees that oversee personnel certification and certificate accreditation.
How AFDO Review Service Speeds Up Retail HACCP Plan Approvals
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.
FDA Aligns U.S. Device Rules With ISO 13485, Replaces QSR With QMSR
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.Global News
ISO 20417 Update Integrates Medical Device Information Into Safety Requirements
The International Organization for Standardization (ISO) has published the second edition of ISO 20417, replacing the 2021 version and reshaping how manufacturers provide information with medical devices by moving beyond labeling into a broader role tied to safety and usability.
ISO Releases Practical Guide To Integrating Multiple Management Systems
ISO has released a new publication, Integrated management systems – A practical guide (IMS PG), offering organizations a clear way to combine multiple management system standards into one coherent system.
ISO TR 25326 Gathers Global Examples Of Green Logistics In Practice
The International Organization for Standardization (ISO) has published ISO/TR 25326:2026, a new international standard that compiles case studies of green logistics to support lower-carbon operations across global supply chains.
BYD Joins IATF As First NEV-Only Automaker And Second Asian Member
The International Automotive Task Force (IATF) has approved the addition of BYD Group as a new member of IATF AISBL,
PAS 1958 Published To Connect Built Environment Data Standards
The British Standards Institution (BSI) has published PAS 1958:2026, a new guide that helps organizations understand how existing data and information standards in the built environment, including buildings and infrastructure, work together within a single framework.
International Quality Awards 2026 Finalists Announced
The Chartered Quality Institute (CQI), a professional body for quality management, has announced the finalists for its International Quality Awards 2026,
ASC Chain Of Custody Set To Become Supply Chain Module In Major Overhaul
The Aquaculture Stewardship Council (ASC), an international non-profit that sets standards for responsible seafood farming,
ISO 22000 Revision Enters Public Enquiry Stage
The International Organization for Standardization (ISO) has moved the revision of ISO 22000 to the public enquiry stage.
ISO 19011 Auditing Standard Enters Final Stage With Hybrid And Digital Shift
The International Organization for Standardization (ISO) has advanced the revision of ISO 19011 to the Final Draft International Standard (FDIS) stage.
IMDRF Playbook Guides Global Use Of Shared Medical Device Regulatory Reviews
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.
DIN Introduces First Framework For AI Testing Tools
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.
