Management Systems World
All on Quality and other Standards in one place since 2010. Now Worldwide.
News Medical Products & Pharmaceuticals
Please note that you have to be a registered member with paid membership in order to see full articles.
RegisterSelected News
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 37011 Webinars on Purpose-Driven Organizations Set for September 22 and 23
Two international webinars on ISO 37011, the draft guidance standard for purpose-driven organizations, will be held on September 22 and 23 ahead of consultation on the draft beginning September 24, 2026.
ISO 45010 Becomes First International Standard on Menstruation and Menopause at Work
ISO has published ISO 45010, the first International Standard focused on supporting employees experiencing menstruation and menopause at work.
Digital Identity Standards Now Freely Accessible Worldwide
Key ISO and IEC digital identity standards, including the ISO/IEC 18013 and ISO/IEC 23220 series, are now freely accessible worldwide through a new sponsorship model set up by the German Institute for Standardization (DIN) and the OpenWallet Foundation (OWF).
GFSI Opens Consultation on FSSC 22000 Version 7 Against 2024 Benchmarking Requirements
The Global Food Safety Initiative (GFSI) has opened a public consultation on the recently updated FSSC 22000 Version 7 as part of its assessment against the GFSI Benchmarking Requirements Version 2024.
Accreditation Bodies Roll Out ISO 14001 Transition Plans
Accreditation bodies are putting the ISO 14001:2026 transition timetable into practice, with Norwegian Accreditation (NA) among the latest to publish detailed arrangements for certification bodies moving to the revised environmental management systems standard.
ISO Considers Three Tourism Proposals on Restaurant Evaluation, Tourist Guides and AI
Three tourism standardization proposals are now under consideration at the International Organization for Standardization (ISO), covering restaurant evaluation, professional tourist guide services and the use of artificial intelligence with tourism destination data.
ISO 14002-3 Released as Guidance on Climate Change
The International Organization for Standardization (ISO) has released ISO 14002-3:2026, new guidance to help organizations using ISO 14001 address climate change through their environmental management systems.
AIQI Publishes First AI Use Case for Management System Certification Decisions
The Artificial Intelligence Quality Infrastructure (AIQI) Consortium has published a new use case examining how AI could support management system certification decisions, including the risks, limitations and controls that conformity assessment bodies may need to consider.
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.
