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

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 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

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

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

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

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

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

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 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.

FDA Aligns U.S. Device Rules With ISO 13485, Replaces QSR With QMSR

The U.S. Food and Drug Administration (FDA) has replaced its long-standing Quality System Regulation (QSR) with the new Quality Management System Regulation (QMSR), changing the legal framework for quality management in the U.S. medical device sector.

NEN Seeks Experts for Clinical Research Standards Committee

The Netherlands Standardization Institute (NEN) is inviting experts to join its Clinical Research standards committee to help shape international standards for clinical investigations of medical devices.

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

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

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

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. 

Public Consultation Opens on ISO 14060, First International Standard for Net Zero Alignment

ISO 14060, the first international standard for net zero alignment, has entered public consultation.

EU Approves EN ISO 15223-1 for Medical Device and IVD Labeling

The European Commission (EC) has approved EN ISO 15223-1, the standard used for symbols on medical device and in vitro diagnostic (IVD) labeling, for use in demonstrating compliance with EU requirements for these products.

GFSI Seeks Feedback on JFSM Recognition Under Benchmarking Requirements v2024

The Global Food Safety Initiative (GFSI) has opened a public stakeholder consultation on the Japan Food Safety Management Association (JFSM) application for recognition under GFSI Benchmarking Requirements Version 2024.

Chery Added as IATF's Third Asian Automotive Group Member

The International Automotive Task Force (IATF) has approved the addition of Chery Automobile, as a new member of IATF AISBL, making it the third Asian automotive group represented in the organization.

IFS Announces June Release of Progress Logistics Version 2

IFS will publish IFS Progress Logistics version 2 at the end of June, updating the program that helps companies prepare for IFS Logistics certification.

Third Cohort of Environmental Management Youth Leadership Group Kicks Off

The third cohort of the ISO Environmental Management (ISO/TC 207) Youth Leadership Group (YLG 3.0) has held its kick-off meeting, bringing together more than 45 participants from around 30 countries.

ISO 9606 Requirements for Welder Qualification Under Revision

The International Organization for Standardization (ISO) is revising ISO 9606, the international standard for qualification testing of welders performing fusion welding.

ISO 9001 Auditing Practices Group Releases First AI-Focused Guidance

The ISO 9001 Auditing Practices Group (APG) has published new guidance on auditing  quality management systems that use artificial intelligence, marking the group's first publication dedicated specifically to AI.