News United States of America


Selected News

FDA Schedules Town Hall On Risk Based Inspections Under New QMSR Framework
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
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
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
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
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
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
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
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 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
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
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
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

How SBTi and GHG Protocol Updates Expand Options for Corporate Emissions Accounting
How SBTi and GHG Protocol Updates Expand Options for Corporate Emissions Accounting
Changes from the Science Based Targets initiative (SBTi) and Greenhouse Gas Protocol, two major frameworks for corporate climate targets and greenhouse-gas accounting, are expanding the options companies have for addressing and accounting for value-chain emissions.
ISO 9001:2026 Officially Launched
ISO 9001:2026 Officially Launched
The sixth edition of ISO 9001, the world’s most widely used quality management system standard, has been officially launched by ISO during a virtual press conference.
Global Responsible Textile Standard (GRTS) Launches for Certification of Wider Range of Fibers
Global Responsible Textile Standard (GRTS) Launches for Certification of Wider Range of Fibers
Global Standards has launched the Global Responsible Textile Standard (GRTS), a new certification standard for textiles made from a wider range of plant, animal, synthetic, man-made cellulosic and recycled fibers.
ISO 45001 Second Edition Clears DIS Ballot With Overwhelming Support
ISO 45001 Second Edition Clears DIS Ballot With Overwhelming Support
The draft second edition of ISO 45001 has passed its Draft International Standard (DIS) vote with only one vote against, moving the revision closer to its planned publication in the first half of 2027.
 
Second Edition of ISO/IEC 17065 Reaches Final Approval Phase
Second Edition of ISO/IEC 17065 Reaches Final Approval Phase
The second edition of ISO/IEC 17065, which sets requirements for bodies that certify products, processes and services, has moved further into the final approval process and is now at stage 50.20 of the Final Draft International Standard (FDIS) phase.
SMART Initiative Enters Pilot Phase in October, Testing Nine Standards
SMART Initiative Enters Pilot Phase in October, Testing Nine Standards
A pilot of the ISO and IEC SMART standards initiative will begin in October, testing nine selected international standards.
New Net Zero Carbon Cities Standard Project Approved as ISO 37115-2
New Net Zero Carbon Cities Standard Project Approved as ISO 37115-2
The International Organization for Standardization (ISO) has approved a proposal for ISO 37115-2, a new standard that will set out principles and fundamentals for net zero carbon cities.
First Edition of ISO 41002 Guides Development of Facility Management Organizations
First Edition of ISO 41002 Guides Development of Facility Management Organizations
The first edition of ISO 41002 gives organizations guidance on how to develop and structure their facility management function across strategic, tactical and operational levels.
ISO/DTS 5112 Road Vehicle Cybersecurity Audit Guidance Reaches Final Approval Stage
ISO/DTS 5112 Road Vehicle Cybersecurity Audit Guidance Reaches Final Approval Stage
ISO/DTS 5112, the draft Technical Specification for auditing cybersecurity management systems (CSMS) across the automotive supply chain, has reached the final approval stage.
ISO 37011 Webinars on Purpose-Driven Organizations Set for September 22 and 23
ISO 37011 Webinars on Purpose-Driven Organizations Set for September 22 and 23
Two international webinars on ISO 37011, the draft guidance standard for purpose-driven organizations, will be held on September 22 and 23 ahead of consultation on the draft beginning September 24, 2026. 
ISO 45010 Becomes First International Standard on Menstruation and Menopause at Work
ISO 45010 Becomes First International Standard on Menstruation and Menopause at Work
ISO has published ISO 45010, the first International Standard focused on supporting employees experiencing menstruation and menopause at work.
Digital Identity Standards Now Freely Accessible Worldwide
Digital Identity Standards Now Freely Accessible Worldwide
Key ISO and IEC digital identity standards, including the ISO/IEC 18013 and ISO/IEC 23220 series, are now freely accessible worldwide through a new sponsorship model set up by the German Institute for Standardization (DIN) and the OpenWallet Foundation (OWF).
We use Cookies