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.

Clearlab Earns MDSAP, ISO 13485 and EU MDR Certifications for Contact Lenses

Clearlab, a manufacturer of vision correction products and lens care solutions, has obtained combined certification under the Medical Device Single Audit Program (MDSAP), ISO 13485, and the European Union Medical Device Regulation (EU MDR).

EU Medical Device Database EUDAMED Opens First Mandatory Modules

The European Commission has published the first four functional modules of EUDAMED, the EU database for medical devices and in vitro diagnostic devices.

Italy Launches Accreditation for ISO 7101 Healthcare Quality Systems

Italy has opened accreditation for certification bodies that audit healthcare organizations against UNI ISO 7101:2024, the standard for quality management in health services.

IEI Secures TFDA QMS Approval and ISO 13485 Certification

IEI Integration Corp, a Taiwan-based provider of medical and industrial computing systems,

FSC Opens Consultation on Chain of Custody Revisions as Two Core Standards Reach Final Phase

The Forest Stewardship Council (FSC) has opened consultation on revisions to five Chain of Custody (CoC) documents, with two core standards now entering the final consultation phase.

CanadaGAP Seeks GFSI Recognition for Updated Food Safety Programs

The Global Food Safety Initiative (GFSI) has opened a public stakeholder consultation as CanadaGAP seeks recognition for updated food safety certification programs covering fruit and vegetable operations.

Efforts to Broaden Application of ISO 21378 Underway

Following last year’s confirmation of ISO 21378:2019, a standard for structured audit data collection and exchange, work within ISO/TC 295/WG 1 is now focused on broadening how the standard is applied across organizations.

ISO 14019-3 Working Draft Reviewed Ahead of October Stage Decision

The development of ISO 14019-3, a proposed international standard on sustainability information validation processes,

First Nuclear Decommissioning Standard Approved for ISO Development

The Korean Agency for Technology and Standards (KATS) will lead development of the world’s first international standard for nuclear power plant decommissioning after its proposal was approved as a new ISO work item.

Public Consultation Opens for Revised ISO 19650-3 BIM Standard

A public consultation has opened for the revised draft of ISO 19650-3, the part of the ISO 19650 series focused on information management during the operational phase of built assets.

ISO/IEC 17021-1 Confirmation Keeps Certification Rules Stable

The International Organization for Standardization’s (ISO) Committee on Conformity Assessment (ISO/CASCO) has confirmed continuation of the current edition of ISO/IEC 17021-1,

Revised ISO 14024 Aims to Prevent Greenwashing in Ecolabel Programs

The International Organization for Standardization (ISO) has published the third edition of ISO 14024, revising requirements for ecolabel certification programs to improve verification of environmental claims and help prevent greenwashing, 

Experts Sought for ISO TS 20008 Food Waste Measurement and Reporting Project

The International Organization for Standardization (ISO) has started development of ISO/AWI TS 20008,

Joint ISO and IEC Team Releases Information Model for SMART Content

The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) have released the first version of the IEC & ISO Information Model for SMART content,

GMP+ International Launches Feed Life Cycle Assessment Standard

The GMP+ International has launched the MI5.7 Feed Life Cycle Assessment LCA standard, introducing a harmonized method for calculating and communicating the environmental impact of feed products across the supply chain.

ISO 22367:2026 Revises Risk Management Guidance for Medical Laboratories

The International Organization for Standardization (ISO) has published ISO 22367:2026, a revised standard that provides medical laboratories with a structured approach to identifying, assessing, and controlling risks across laboratory activities and testing processes.