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Serbian Pharma Conference Explores Digital Transformation of GxP Activities
The Chamber of Commerce and Industry of Serbia (PKS) hosted a professional conference on October 30 focusing on the digitalization of GxP (Good Practice) activities across the supply chain for human medicines.
CEN Launches Development of EN 17483-5 on Health Security Services
The European Committee for Standardization (CEN) has begun work on EN 17483-5, a new standard focusing on health security services for the healthcare sector.
Indonesia Makes Halal Certification Compulsory for Imported Food and Beverages by 2026
Starting October 17, 2026, Indonesia will require halal certification for imported food and beverages,
Medsalv Achieves ISO 13485 Certification in New Zealand and Australia
Medsalv, a healthcare company specializing in remanufacturing single-use medical devices, has achieved certification to ISO 13485 across both New Zealand and Australia.
First Medical Biobank Accreditation in Netherlands Underway as RvA Prepares for EA Evaluation
The first medical biobank in the Netherlands has applied for accreditation under ISO 20387.
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.
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.
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.Global News
ISO 11462-1:2026 Updates Statistical Process Control to Reduce Process Variation
The International Organization for Standardization (ISO) has published ISO 11462-1:2026, updating guidance on statistical process control (SPC) to help organizations improve the stability and capability of their processes.
Codex Sets New Labelling Rules for Multipacks and Outer Packaging
The Codex Alimentarius Commission (CAC) has adopted new requirements for foods sold in multipacks or grouped together in one outer package, clarifying what information must appear on the packaging consumers see when buying the product.
SBTi Net-Zero Standard Version 2.0 Adds New Rules for Corporate Climate Targets, Reporting and Carbon Removals
The Science Based Targets initiative (SBTi) published Version 2.0 of its Corporate Net-Zero Standard on June 11, introducing new requirements for how companies set climate targets, plan their transition to net zero, report progress and deal with emissions that remain.
CSA Group to Sell Testing and Certification Business to Kiwa
Kiwa and CSA Group have agreed on a deal worth around $1.5 billion for Kiwa to acquire CSA Group’s testing, inspection and certification business, significantly expanding the Dutch company’s presence in North America.
ISO/IEC 25005-1:2026 Creates Common Framework for How Smart Cities Use Data
ISO/IEC 25005-1:2026, published in July, provides a common international framework for how smart cities can make better use of data across urban governance and services.
Global ACI Delays Launch of New MRA Mark Pending Trademark Registration
Global Accreditation Cooperation Incorporated (Global ACI) has paused the launch of its new Multilateral Recognition Arrangement (MRA) Mark while trademark registrations are completed across member economies.
Major Changes Coming to ISO/IEC Standard-Development Rules
ISO and IEC will put a major rewrite of ISO/IEC Directives, Part 1 into effect on October 5, changing the common rules used to develop, maintain and manage international standards and other publications.
ISO 20001 Set for Publication as First Food Loss and Waste Management Standard
ISO 20001, the world’s first ISO management system standard dedicated to food loss and waste reduction, is scheduled for publication on September 29, 2026, marking the International Day of Awareness of Food Loss and Waste.
Upcoming ISO/UNDP 53001 Sets First Management System Requirements for the SDGs
ISO/UNDP 53001, set for publication in September 2026, will provide the first management system requirements specifically for organizations seeking to manage and improve their contribution to the Sustainable Development Goals (SDGs).
VDA Releases VDA 5.4 Draft for Fastening Measurement Tools
The Quality Management Center of the German Association of the Automotive Industry (VDA QMC) has released VDA 5.4, Interface for measuring tools in fastening technology, as a Yellow Volume for industry feedback.
ISO/CASCO Clarifies: ISO/IEC 17025 Does Not Require Labs to Treat Accreditation Bodies as Suppliers
The maintenance group of the International Organization for Standardization’s Committee on Conformity Assessment (ISO/CASCO) has clarified that ISO/IEC 17025:2017 does not require laboratories to treat their accreditation bodies as external service providers subject to the standard’s supplier controls.
