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Mountain Healthcare First In UK To Achieve ISO 15189 Accreditation For SARC Services
Mountain Healthcare has become the first provider in the UK to achieve accreditation from the United Kingdom Accreditation Service (UKAS) to ISO 15189:2022 for its Sexual Assault Referral Centres (SARCs),
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.Global News
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.
ISO 9002 Revision Reaches Public Comment Stage
The International Organization for Standardization (ISO) has advanced the revision of ISO 9002 to the Draft International Standard (DIS) stage, opening the project for wider review and feedback.
