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,

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.

IFS Updates Food, Logistics, Broker And Pacsecure Doctrines To Clarify Certification Rules

The International Featured Standards (IFS) has published updated doctrine documents for its current standards covering food production, logistics, brokerage, and packaging materials, clarifying how certification requirements should be applied without revising the standards themselves.

PAS 25535 on Sustainability in Asset Management Reaches Draft Stage

PAS 25535, a specification focused on integrating sustainability into asset management systems, has reached the committee draft stage within the International Organization for Standardization (ISO), marking the close of its initial comment period. 

ISO 9001 Revision Moves to FDIS Stage as Early Analysis Questions Scope of Changes

The International Organization for Standardization (ISO) has confirmed that the revision of ISO 9001 has entered the Final Draft International Standard (FDIS) stage, marking the last step before publication.

DIN to Lead ISO IEC Joint Technical Committee 5 on Digital Product Passport Standards

Following an initiative by the German Institute for Standardization (DIN) and the German Commission for Electrical, Electronic & Information Technologies (DKE),

ANSI/TIA-942 Addendum Targets AI Data Center Cooling and High-Density Needs

The Telecommunications Industry Association (TIA) is developing a new addendum to the ANSI/TIA-942 data center standard to address the growing demands of artificial intelligence (AI) infrastructure.

IATF Introduces Mandatory Auditor Training for Corporate Scheme Audits

The International Automotive Task Force (IATF) has approved a new mandatory training module to strengthen how auditors assess organizations certified under corporate audit schemes for IATF 16949.

ISO/TS 19384 Sets First Standard for Digital Service Excellence

The International Organization for Standardization (ISO) has released ISO/TS 19384:2026,

FSSC Issues Five Sector-Specific Guides for Development Program Implementation

The Foundation for Food Safety Certification (FSSC) has published five sector-specific guidance documents to support organizations using the FSSC Development Program,

ISO 14001 Fourth Edition Officially Released

The International Organization for Standardization (ISO) has published ISO 14001:2026, marking the release of the fourth edition of the world’s most widely used environmental management systems standard. 

Global ACI Introduced: IAF and ILAC Successor Presents New Identity

A new international accreditation body, Global Accreditation Cooperation Incorporated, has introduced a new identity as Global ACI, including a logo and communication channels after starting operations on January 1, 2026.

ISO 17067 Revision Expands Conformity Assessment Schemes

The International Organization for Standardization (ISO) Committee on Conformity Assessment (CASCO) is revising ISO/IEC 17067 to expand its scope from product certification to a broader framework for conformity assessment schemes.

ISO Establishes Working Group on Environmental and Social Impact Data in Agrifood Systems

The International Organization for Standardization (ISO) has set up a new working group under ISO/TC 347 to develop a standardized way to record and share data on environmental and social impacts across agrifood supply chains.