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.

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.

FDA Partially Recognizes ISO 10993-1:2025 for Medical Devices

The U.S. Food and Drug Administration (FDA) has partially recognized ISO 10993-1:2025, the latest edition of the international standard used to assess the biological safety of medical devices.

Licensing Instead of Sales: ISO Changes How Standards Are Used

The International Organization for Standardization (ISO) is preparing to replace its traditional standards sales approach with a licensing model that would give users defined rights to use standards content instead of broad unrestricted access.

BRCGS Updates Food Safety, Packaging, Storage, and Broker Rules to Meet New GFSI Requirements

BRCGS has updated certification requirements for its Food Safety, Packaging Materials, Storage and Distribution, and Agents and Brokers standards,

ISO 45001 Revision Signals Changes in How Companies Manage Workplace Safety

The revision of ISO 45001 is expected to push companies beyond traditional workplace safety management by placing greater emphasis on mental health, organizational resilience, safety culture, and climate-related risks.

International Olympic Committee Certified to ISO 20121 Event Sustainability Standard

The International Olympic Committee (IOC) has been re-certified to ISO 20121:2024 for sustainability management at the corporate events it directly organizes and finances, including IOC Sessions, conferences, Olympic Day activities, and commission meetings.

Core Industrial Safety Framework IEC 61508 Undergoes Major Revision

The IEC 61508 series, the international foundation for many industrial functional safety standards,

FSC Proposes New Rules for Certification Statements and Audit Duration

The Forest Stewardship Council (FSC) has opened a public consultation on two draft Advice Notes that would update certification body requirements related to certification statements and minimum audit duration for Forest Management audits.

ILO Moves to Modernize International Labour Standards Reporting

The International Labour Organization (ILO) is preparing a major overhaul of how countries report on international labour standards.

ISO 9001 Revision Moves Into Formal FDIS Ballot Phase

The International Organization for Standardization (ISO) has advanced the revision of ISO 9001 to the next step of the Final Draft International Standard (FDIS) approval process, with the project now listed at stage 50.20 following the earlier 50.00 status.

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.