News Medicine / Pharmaceutical


Selected News

Dutch Healthcare Information Security Standard Updated to Align With ISO 27799
Dutch Healthcare Information Security Standard Updated to Align With ISO 27799
The Royal Netherlands Standardization Institute (NEN) has published an amendment to NEN 7510-2 to align it with ISO 27799,
China Clarifies Registration Rules for Special Medical Foods Under New Standards
China Clarifies Registration Rules for Special Medical Foods Under New Standards
The State Administration for Market Regulation (SAMR) has issued a Q&A to explain how foods for special medical purposes (FSMP) should be registered under China’s updated national standards, helping companies understand how to apply the new rules in practice.
AKH Wien Becomes First Hospital In Austria Certified For Diversity Management
AKH Wien Becomes First Hospital In Austria Certified For Diversity Management
The Vienna General Hospital (AKH Wien) has become the first hospital in Austria to receive certification for its diversity management system,
FDA Schedules Town Hall On Risk Based Inspections Under New QMSR Framework
FDA Schedules Town Hall On Risk Based Inspections Under New QMSR Framework
The U.S. Food and Drug Administration (FDA) has announced a Town Hall on April 1, 2026, to explain how inspections of medical device manufacturers will change under its new Quality Management System Regulation (QMSR), with a focus on a risk-based approach.
Mountain Healthcare First In UK To Achieve ISO 15189 Accreditation For SARC Services
Mountain Healthcare First In UK To Achieve ISO 15189 Accreditation For SARC Services
Mountain Healthcare has become the first provider in the UK to achieve accreditation from the United Kingdom Accreditation Service (UKAS) to ISO 15189:2022 for its Sexual Assault Referral Centres (SARCs),
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.
Free Risk Tool Launched for Healthcare Information Security Standard NEN 7510
Free Risk Tool Launched for Healthcare Information Security Standard NEN 7510
The Netherlands Standardization Institute (NEN) has launched a free risk analysis tool to help healthcare organizations and other entities that process personal health data carry out the information security risk assessment required under NEN 7510.
Hoan My International Hospital Laboratory Earns ISO 15189 Accreditation
Hoan My International Hospital Laboratory Earns ISO 15189 Accreditation
The medical laboratory of Hoan My International Hospital has received ISO 15189:2022 accreditation from the National Accreditation Bureau (BoA),
EU Expands Laboratory Oversight for Highest Risk In Vitro Diagnostic Devices
EU Expands Laboratory Oversight for Highest Risk In Vitro Diagnostic Devices
The European Union (EU) has expanded oversight of Class D in vitro diagnostic medical devices under Regulation (EU) 2017/746, known as the In Vitro Diagnostic Regulation (IVDR).
BIS Seeks Public Feedback on Draft Standards for Medical Devices and Healthcare
BIS Seeks Public Feedback on Draft Standards for Medical Devices and Healthcare
The Bureau of Indian Standards (BIS), through its Medical Equipment and Hospital Planning Department,
NATA Seeks Experts in Software as Medical Devices and AI for Human Pathology Advisory Committee
NATA Seeks Experts in Software as Medical Devices and AI for Human Pathology Advisory Committee
The National Association of Testing Authorities, Australia (NATA) is inviting expressions of interest to join its Human Pathology Accreditation Advisory Committee,
Denmark Aligns Accreditation Rules for Referral Laboratories and Specialists With ISO 15189
Denmark Aligns Accreditation Rules for Referral Laboratories and Specialists With ISO 15189
Denmark has revised its national accreditation rules for the use of referral laboratories and external specialists to align with the Danish version of ISO 15189:2022 for medical laboratories.

Global News

ISO and IEC Update AI Rules for Standards Development
ISO and IEC Update AI Rules for Standards Development
ISO and IEC have published updated guidance on the use of artificial intelligence in technical committees, defining how AI may be used during the development of international standards. 
BRCGS Updates Packaging Materials Issue 7 Requirements for GFSI Benchmarking 2024
BRCGS Updates Packaging Materials Issue 7 Requirements for GFSI Benchmarking 2024
BRCGS has updated the requirements for its Packaging Materials Issue 7 certification scheme to meet the GFSI Benchmarking Requirements 2024.
SIS Opens Draft ISO 9002 for Public Comment
SIS Opens Draft ISO 9002 for Public Comment
The Swedish Institute for Standards (SIS) has opened public access to the draft version of ISO 9002, allowing organizations and quality professionals to read and comment on the official guidance for applying ISO 9001 before the document is finalized.
Busy Week Brings Four Automotive Quality Updates
Busy Week Brings Four Automotive Quality Updates
It has been a busy week for automotive quality, with four significant updates released for the sector.
ISO 33400:2026 Sets International Vocabulary for Reference Materials
ISO 33400:2026 Sets International Vocabulary for Reference Materials
The International Organization for Standardization (ISO) has published ISO 33400:2026, updating the international vocabulary for reference materials (RM) and certified reference materials (CRM).
TIC Council Backs ISO 14019 as Framework for Sustainability Assurance
TIC Council Backs ISO 14019 as Framework for Sustainability Assurance
The International Association for Testing, Inspection and Certification (TIC Council) has published a paper urging policymakers to recognize the ISO 14019 series as the framework for sustainability assurance,
IFS Updates Progress Scoring Guide for Food and Logistics Programs
IFS Updates Progress Scoring Guide for Food and Logistics Programs
International Featured Standards (IFS) has updated its Progress Scoring System brochure following the recent launch of IFS Progress Logistics 2.
CQI Announces International Quality Awards 2026 Winners
CQI Announces International Quality Awards 2026 Winners
The Chartered Quality Institute (CQI) announced the winners of the International Quality Awards 2026 during the Quality Live event in London on June 25,
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. 
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