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Hong Ngoc Hospital Gene Center Accredited to ISO 15189 for Medical Labs
The National Accreditation Bureau (BoA) has accredited the Gene Center at Hong Ngoc General Hospital - Phuc Truong Minh under ISO 15189,
DAkkS Completes ISO 15189 Transition With All Medical Labs in Germany Retaining Accreditation
The Deutsche Akkreditierungsstelle (DAkkS), Germany’s national accreditation body, has successfully completed the nationwide changeover to the revised DIN EN ISO 15189 standard for medical laboratories.
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.Global News
ISO 9002 Revision Reaches Public Comment Stage
The International Organization for Standardization (ISO) has advanced the revision of ISO 9002 to the Draft International Standard (DIS) stage, opening the project for wider review and feedback.
Global ACI Sets 36-Month Transition for ISO/IEC 17024:2026
The Global Accreditation Cooperation Incorporated (Global ACI) has established a 36-month transition period for ISO/IEC 17024:2026, the newly revised international standard for bodies that certify individuals.
PAS 96:2026 Updates Food Defence Guidance for Emerging Threats
The British Standards Institution (BSI) has published PAS 96:2026, a fully revised edition of its food defence guide.
BRCGS Updates Meat Supply Chain Assurance Module
The British Retail Consortium Global Standards (BRCGS) has updated its Additional Module 11: Meat Supply Chain Assurance.
ISO 29997 Offers First International Framework for Quality Internships
ISO 29997:2025 provides the first international framework designed to help organizations deliver higher-quality internships through clearer planning, management and evaluation practices.
Experts Behind ISO 14001:2026 Explain New Focus on Climate, Biodiversity and Results
The International Organization for Standardization (ISO) has outlined the most important changes in ISO 14001:2026,
New ISO/IEC 15408 and 18045 Editions Update Common Criteria Framework
ISO/IEC 15408-1:2026 and ISO/IEC 18045:2026 have been published, updating the Common Criteria framework, an international system used to evaluate the security of IT products.
FDA Partially Recognizes ISO 10993-1:2025 for Medical Devices
The U.S. Food and Drug Administration (FDA) has partially recognized ISO 10993-1:2025, the latest edition of the international standard used to assess the biological safety of medical devices.
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.
