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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.
Winter Issue of ANSI in China Newsletter Highlights 2025 Developments
The American National Standards Institute (ANSI) has released the Winter 2025 edition of the ANSI in China Newsletter, outlining recent standards, policy, and regulatory developments linked to U.S. and China engagement.
Baldrige Foundation Announces 2026 Leadership Award Recipients
The Foundation for the Malcolm Baldrige National Quality Award has announced the 2026 recipients of its Leadership Awards,
NIST Releases Draft on How Cybersecurity Programs Can Adapt to Artificial Intelligence
The National Institute of Standards and Technology (NIST) has released a preliminary draft that explains how organizations can adapt their cybersecurity programs to the growing use of artificial intelligence.
USPTO Creates Standard-Essential Patent Working Group Amid Licensing Disputes
The United States Patent and Trademark Office (USPTO) has created a new Standard-Essential Patent Working Group as disputes continue over how patented technologies built into technical standards are licensed and enforced.
Baldrige Performance Excellence Program Transitions to Two Private-Sector Partners
Beginning with the 2026 award cycle, most operational responsibilities for the Baldrige Performance Excellence Program will shift to two private-sector organizations, while federal authorities retain ownership and oversight of the framework and award process.
NIST Invites Comments on Guide Connecting Cybersecurity, ERM and Workforce Planning
The National Institute of Standards and Technology (NIST) has released the draft Special Publication 1308 2pd,
ANSI Sets Schedule for 2026 Standards Action Updates
The American National Standards Institute (ANSI) has released its 2026 Standards Action publishing calendar,
Quality Drives U.S. Manufacturing Resilience, ZEISS Report Finds
A new U.S. Manufacturing Insights Report 2025 from ZEISS Industrial Quality Solutions reveals that 93% of American manufacturers view quality assurance as mission-critical to overcoming industry challenges and maintaining competitiveness.
ANSI Honors 20 Leaders Advancing U.S. Standardization and Conformity Assessment
The American National Standards Institute (ANSI) recognized 20 outstanding professionals for their leadership in standards, conformity assessment, and workforce development during its 2025 Leadership and Service Awards Banquet on October 22.
U.S. Report Tracks Progress on 3D Printing Standards Gaps
America Makes and the American National Standards Institute (ANSI) released the September 2025 Gaps Progress Report,
Standards That Help Tackle the Growing Problem of Trash in Space
As Earth’s orbit becomes increasingly crowded with defunct satellites, rocket parts, and collision fragments, the need for global standards to manage space debris has become urgent.Global News
Public Consultation Opens on ISO 14060, First International Standard for Net Zero Alignment
ISO 14060, the first international standard for net zero alignment, has entered public consultation.
EU Approves EN ISO 15223-1 for Medical Device and IVD Labeling
The European Commission (EC) has approved EN ISO 15223-1, the standard used for symbols on medical device and in vitro diagnostic (IVD) labeling, for use in demonstrating compliance with EU requirements for these products.
GFSI Seeks Feedback on JFSM Recognition Under Benchmarking Requirements v2024
The Global Food Safety Initiative (GFSI) has opened a public stakeholder consultation on the Japan Food Safety Management Association (JFSM) application for recognition under GFSI Benchmarking Requirements Version 2024.
Chery Added as IATF's Third Asian Automotive Group Member
The International Automotive Task Force (IATF) has approved the addition of Chery Automobile, as a new member of IATF AISBL, making it the third Asian automotive group represented in the organization.
IFS Announces June Release of Progress Logistics Version 2
IFS will publish IFS Progress Logistics version 2 at the end of June, updating the program that helps companies prepare for IFS Logistics certification.
Third Cohort of Environmental Management Youth Leadership Group Kicks Off
The third cohort of the ISO Environmental Management (ISO/TC 207) Youth Leadership Group (YLG 3.0) has held its kick-off meeting, bringing together more than 45 participants from around 30 countries.
ISO 9606 Requirements for Welder Qualification Under Revision
The International Organization for Standardization (ISO) is revising ISO 9606, the international standard for qualification testing of welders performing fusion welding.
ISO 9001 Auditing Practices Group Releases First AI-Focused Guidance
The ISO 9001 Auditing Practices Group (APG) has published new guidance on auditing quality management systems that use artificial intelligence, marking the group's first publication dedicated specifically to AI.
ISO 10993-6 Standard for Implantation Testing Updated
The International Organization for Standardization (ISO) has published a revised edition of ISO 10993-6, expanding guidance for implantation studies used in the biological evaluation of medical devices.
All 12 Recognized Food Safety Program Owners Apply for GFSI Version 2024 Recognition
The Consumer Goods Forum's Global Food Safety Initiative (GFSI) has confirmed that all 12 previously recognized Certification Program Owners (CPOs) have applied for recognition against the GFSI Benchmarking Requirements Version 2024.
ISO 14002-3 Climate Guidance Advances to Final Draft Stage
ISO 14002-3, a guidance standard for managing climate-related issues within ISO 14001 environmental management systems, has advanced to the Final Draft International Standard (FDIS) stage.
