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Selected News

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.
Winter Issue of ANSI in China Newsletter Highlights 2025 Developments
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.

Global News

IAQG Centralizes Aerospace Auditor Authentication
IAQG Centralizes Aerospace Auditor Authentication
The International Aerospace Quality Group (IAQG) has centralized the authentication of aerospace quality management system auditors, replacing the previous network of independent Auditor Authentication Bodies (AABs).
FSC Revised Trademark Standard Takes Effect
FSC Revised Trademark Standard Takes Effect
The Forest Stewardship Council (FSC) has launched a new online training course to support implementation of its revised trademark standard, FSC-STD-50-001 V3-0, which takes effect on July 1, 2026. 
SIS Offers Free Access to ISO 45001 Draft
SIS Offers Free Access to ISO 45001 Draft
The Swedish Institute for Standards (SIS) has made the proposed second edition of ISO 45001 - draft available for free download and public review,
 
ISO/DIS 9002 Ballot Opens for Comment
ISO/DIS 9002 Ballot Opens for Comment
The International Organization for Standardization (ISO) has released ISO/DIS 9002 for ballot, opening the international comment period on the revision of the guidance standard for applying ISO 9001. 
Public Consultation Opens on ISO 14060, First International Standard for Net Zero Alignment
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
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
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
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 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
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
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
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. 
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