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.

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).

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.

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.

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.

AFNOR can now issue CE Marking certificates for Medical Devices. Looking for Auditors

AFNOR Certification is actively seeking auditors specialized in medical device compliance to help meet a growing need for CE marking services.

First Products and Test Facilities Certified Under New IEEE Medical Device Cybersecurity Program

The IEEE has officially certified the first medical devices and test facilities

NHS Requires Antibiotic Suppliers to Meet New AMR Certification Standard

The NHS is stepping up its fight against superbugs by setting a new standard for antibiotic suppliers.

Global ACI Explains Which IAF and ILAC Documents Remain in Force During Transition

The Global Accreditation Cooperation Incorporated (Global ACI) has published a cross-reference tableshowing the status of former International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) publications.

Standards Behind the FIFA World Cup 2026

As the FIFA World Cup 2026 gets underway across the United States, Canada and Mexico,

CEN and CENELEC Open Nominations for 2026 Standards+Innovation Awards

The 2026 Standards+Innovation Awards are now accepting nominations for individuals and projects that have contributed to standardization through research, innovation and education.

PEFC Launches Project Sourcing Certification for Construction Projects

The Programme for the Endorsement of Forest Certification (PEFC) has launched a new Project Sourcing certification program for the construction sector.

Development Begins on ISO 59001 Circular Economy Management Standard

The International Organization for Standardization (ISO) has begun development of ISO 59001, a future certifiable management system standard for the circular economy.

ISO 32212 Introduces Net Zero Transition Planning Framework for Finance

The International Organization for Standardization (ISO) has published ISO 32212:2026,

ISO 45010 Workplace Menstruation and Menopause Guidance Advances to Final Approval Stage

The International Organization for Standardization (ISO) has advanced ISO 45010, which provides guidance on menstruation and menopause in the workplace, has advanced to the Final Draft International Standard - FDIS stage.

ISO Considers New Committee for Tunnel Design

A proposal to create a dedicated ISO technical committee for tunnel design is under consideration.

FSC Invites Feedback on Four Active Consultations

The Forest Stewardship Council (FSC) is inviting feedback on four active consultations.

CQI Launches Knowledge Hub for Quality Professionals

The Chartered Quality Institute (CQI) has launched a new Knowledge Hub that brings together quality information, learning resources and industry insights in one place.

July 15 Deadline Nears for GMP+ Certificates Issued by DNV Italy and LL-C

GMP+ International has warned companies GMP+ Feed certificates issued by DNV Business Assurance Italy S.R.L. or LL-C Certification Czech Republic a.s. that

ISO 9000 and ISO 19011 Revised: New Guidance for Quality and Auditing

Two cornerstone standards for quality management and auditing have been revised, with the International Organization for Standardization (ISO) publishing new editions of ISO 9000 and ISO 19011.