NEN Seeks Dutch Experts for In Vitro Diagnostics Standards Committee

The Netherlands Standardization Institute (NEN) is seeking Dutch experts to join its In Vitro Diagnostics (IVD) standards committee.

NSAI Seeks Feedback on Potential Revisions to ISO 13485 for Medical Device Quality

The National Standards Authority of Ireland (NSAI) is inviting users of ISO 13485:2016 to share their input on possible revisions through a survey.

Standard Norway Seeks Experts for European Healthcare Standards Group

Standard Norway is inviting 4-6 professionals to join the newly established CEN/CENELEC SAG Healthcare standards group, which aims to identify and address standardization needs in the healthcare sector.

NEN Initiates Development of Sustainability Guidelines for Medical Devices

In April 2025, the Netherlands Standardization Institute (NEN) will begin creating a Dutch Practical Guideline (NPR) focused on the sustainability of medical devices.

Medical Device Industry at Midpoint in Transition to FDA’s ISO 13485-Based QMSR

A year ago, the FDA adopted ISO 13485 into its Quality System Regulation, rebranding it as the Quality Management System Regulation (QMSR).

Topolšica Hospital Achieves Slovenia's First ISO 7101 Certification

Topolšica Hospital has become the first medical institution in Slovenia to earn the ISO 7101 certification for management systems for quality in healthcare organizations.

How EU’s Unique Device Identification Enhances Medical Device Safety

The European Medical Device Regulation (EU) 2017/745 (MDR) requires all medical device manufacturers to assign a Unique Device Identification (UDI) to their products.

ISBIH Translates ISO 15189 Standard for Medical Laboratories

The Institute for Standardization of Bosnia and Herzegovina (ISBIH) has translated the latest edition of the international standard Medical Laboratories—Requirements for Quality and Competence, and issued it as BAS EN ISO 15189:2022.

Dutch Standard on Ultraviolet Sterilization of Medical Devices Open for Comments

The The Dutch standardization body (NEN) is inviting comments on its draft standard, NEN 8281.

Netherlands Updates Standard for IT Security in Healthcare

The updated Dutch standard for information security in healthcare is now available on the NEN Connect, the platform of the Netherlands' national standards organization.

Fourth Edition of Swedish Handbook for Medical Gas Facilities Published

The Swedish Standards Institute (SIS) has released the fourth edition of SIS Handbook 370: Safety Standard for Medical Gas Facilities.

EU’s QUANTUM Project Aims to Create a Standardized Health Data Quality and Utility Label

The QUANTUM project is an initiative that aims to create a standardized health data quality and utility label for the secondary use of health data across the EU.

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.

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,