FDA Shift to ISO 13485 Makes Live Quality Management System Essential for Medical Devices

Starting February 2, 2026, the U.S. Food and Drug Administration (FDA) will align its Quality System Regulation with ISO 13485:2016, making it the foundation for all medical device market submissions.

NATA Publishes Biobanking Guide to Strengthen Trust in Stored Biological Materials

The National Association of Testing Authorities (NATA) has released a new Biobanking Industry Guide to help organizations understand the importance of accreditation in maintaining reliable, high-quality biological materials for long-term research and data use.

Cofrac Updates Accreditation Guides for Pathology and Reproductive Biology Labs

The French Accreditation Committee (Cofrac) has released revised versions of two technical accreditation guides, SH GTA 03 and SH GTA 05, aligning them with the 2022 edition of the standard NF EN ISO 15189, the French version of the standard for quality and competence in medical laboratories.

NIST Standard Enables Accurate Dosage of New Anticancer Drugs

The National Institute of Standards and Technology (NIST) has developed the first U.S. standard for measuring the radioactivity of actinium-225, a key ingredient in a new class of anticancer drugs.

Verne Health Earns Triple Certification for Information Security and Quality

Dutch healthcare technology company Verne Health, developer of the Verne EPD Platform for healthcare professionals and hospitals,

Consultation Open on Safe Handling of Sterile Medical Equipment in Norway

Standard Norway has opened a consultation on a new technical specification that sets clear requirements for storing, handling, and transporting sterile medical equipment in Norwegian healthcare services.

Russia Now Requires Local Representative for Foreign Medical Device Registration

Foreign manufacturers with medical devices registered in Russia must appoint a Russian Authorized Representative (RUS REP) or update existing representative details by August 31, 2025.

Public Consultation Opens in Norway on Patient Pathway Standard for Diagnostic Imaging

A draft Norwegian version of a new European standard for the patient pathway in diagnostic imaging is now open for public consultation until May 1.

UK to Tighten Post-Market Rules for Medical Devices Starting June 2025

The UK’s new Post-Market Surveillance (PMS) regulations for medical and in vitro diagnostic devices will come into force on June 16, 2025.

NHSGGC Biorepository Becomes First in UK to Earn UKAS Accreditation Under ISO 20387

NHS Greater Glasgow and Clyde's (NHSGGC) Biorepository is the first facility in the UK to receive UKAS accreditation under ISO 20387:2018, the international standard for biobanking.

NEN Seeks Dutch Experts for In Vitro Diagnostics Standards Committee

The Netherlands Standardization Institute (NEN) is seeking Dutch experts to join its In Vitro Diagnostics (IVD) standards committee.

NSAI Seeks Feedback on Potential Revisions to ISO 13485 for Medical Device Quality

The National Standards Authority of Ireland (NSAI) is inviting users of ISO 13485:2016 to share their input on possible revisions through a survey.

Licensing Instead of Sales: ISO Changes How Standards Are Used

The International Organization for Standardization (ISO) is preparing to replace its traditional standards sales approach with a licensing model that would give users defined rights to use standards content instead of broad unrestricted access.

BRCGS Updates Food Safety, Packaging, Storage, and Broker Rules to Meet New GFSI Requirements

BRCGS has updated certification requirements for its Food Safety, Packaging Materials, Storage and Distribution, and Agents and Brokers standards,

ISO 45001 Revision Signals Changes in How Companies Manage Workplace Safety

The revision of ISO 45001 is expected to push companies beyond traditional workplace safety management by placing greater emphasis on mental health, organizational resilience, safety culture, and climate-related risks.

International Olympic Committee Certified to ISO 20121 Event Sustainability Standard

The International Olympic Committee (IOC) has been re-certified to ISO 20121:2024 for sustainability management at the corporate events it directly organizes and finances, including IOC Sessions, conferences, Olympic Day activities, and commission meetings.

Core Industrial Safety Framework IEC 61508 Undergoes Major Revision

The IEC 61508 series, the international foundation for many industrial functional safety standards,

FSC Proposes New Rules for Certification Statements and Audit Duration

The Forest Stewardship Council (FSC) has opened a public consultation on two draft Advice Notes that would update certification body requirements related to certification statements and minimum audit duration for Forest Management audits.

ILO Moves to Modernize International Labour Standards Reporting

The International Labour Organization (ILO) is preparing a major overhaul of how countries report on international labour standards.

ISO 9001 Revision Moves Into Formal FDIS Ballot Phase

The International Organization for Standardization (ISO) has advanced the revision of ISO 9001 to the next step of the Final Draft International Standard (FDIS) approval process, with the project now listed at stage 50.20 following the earlier 50.00 status.

FSC Opens Consultation on Chain of Custody Revisions as Two Core Standards Reach Final Phase

The Forest Stewardship Council (FSC) has opened consultation on revisions to five Chain of Custody (CoC) documents, with two core standards now entering the final consultation phase.

CanadaGAP Seeks GFSI Recognition for Updated Food Safety Programs

The Global Food Safety Initiative (GFSI) has opened a public stakeholder consultation as CanadaGAP seeks recognition for updated food safety certification programs covering fruit and vegetable operations.

Efforts to Broaden Application of ISO 21378 Underway

Following last year’s confirmation of ISO 21378:2019, a standard for structured audit data collection and exchange, work within ISO/TC 295/WG 1 is now focused on broadening how the standard is applied across organizations.

ISO 14019-3 Working Draft Reviewed Ahead of October Stage Decision

The development of ISO 14019-3, a proposed international standard on sustainability information validation processes,