IEI Secures TFDA QMS Approval and ISO 13485 Certification

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

NEN Sets Initial Scope For New Guideline On Sustainable Medical Devices

The Netherlands Standardization Institute (NEN) has set the initial scope for developing a new Dutch Practice Guideline (NPR) on sustainability in medical devices.

Mexico Recognizes MDSAP as Equivalent to National Medical Device GMP

Mexico has issued a new interpretation rule for the NOM-241-SSA1-2025 standard on good manufacturing practices (GMP) for medical devices, confirming that

Dutch In Vitro Standards Committee Presents Broad Agenda for New Laboratory Standards

The Dutch In Vitro Diagnostics Standards Committee is driving a wide range of international work on new laboratory and diagnostic standards, reflecting the rapid rise of digital tools, artificial intelligence, and smarter testing systems.

Standard Norway to Establish National Committee on Medical Device Standards

Standard Norway (SN) is creating a new national mirror committee, SN/K 113, to contribute to international standardization on quality management for medical devices.

Sweden Moves to Standardize Medicine Dispenser APIs

Sweden has launched work on a national standard for Application Programming Interfaces (APIs) used in automated medicine dispensers.

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.

Standardizing Hospital Design Terminology with New UNI 11993

Italy’s national standards body UNI has published UNI 11993, a new standard that defines terminology for hospital and healthcare structures to

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.

IQTIG Updates List of Healthcare Certificates and Quality Seals for German Federal Hospital Atlas

The Institute for Quality Assurance and Transparency in Healthcare (IQTIG) has published an updated list of certificates and quality seals for inpatient healthcare providers.

ABNT Launches ISO 7101 to Advance Quality in Health Organizations

The Associação Brasileira de Normas Técnicas (ABNT) has officially launched the Brazilian version of ISO 7101,

Inacal Creates New Technical Committee to Improve Health Sector Management in Peru

The National Institute for Quality (Inacal) in Peru has launched a new Technical Standardization Committee focused on the management of healthcare organizations.

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.

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.