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Selected News

Cofrac Updates Map Of Accredited Medical Biology Laboratories In France
Cofrac Updates Map Of Accredited Medical Biology Laboratories In France
The French Accreditation Committee (Cofrac) has released an updated map showing the distribution of accredited medical biology laboratories (LBM) across France as of April 1, 2026.
China Updates Laboratory Accreditation Rules for Medical Device Testing
China Updates Laboratory Accreditation Rules for Medical Device Testing
China National Accreditation Service for Conformity Assessment (CNAS) has issued a revised version of its guidance for applying laboratory accreditation criteria in medical device testing, with CNAS-CL01-A004:2026 set to take effect on May 1, 2026. 
China Tightens GMP Rules For Medical Device Manufacturers Effective November 2026
China Tightens GMP Rules For Medical Device Manufacturers Effective November 2026
The National Medical Products Administration (NMPA) has revised China’s Good Manufacturing Practice (GMP) requirements for medical devices, introducing stricter quality management system rules that will take effect on November 1, 2026 and replace the current 2014 version.
India Invites MSMEs to Join Healthcare Standards Committees
India Invites MSMEs to Join Healthcare Standards Committees
The Bureau of Indian Standards (BIS) is inviting micro, small, and medium enterprises (MSMEs) to join technical committees in its Medical Equipment and Hospital Planning Department (MHD), opening the standardization process to a wider range of industry participants. 
Dutch Healthcare Information Security Standard Updated to Align With ISO 27799
Dutch Healthcare Information Security Standard Updated to Align With ISO 27799
The Royal Netherlands Standardization Institute (NEN) has published an amendment to NEN 7510-2 to align it with ISO 27799,
China Clarifies Registration Rules for Special Medical Foods Under New Standards
China Clarifies Registration Rules for Special Medical Foods Under New Standards
The State Administration for Market Regulation (SAMR) has issued a Q&A to explain how foods for special medical purposes (FSMP) should be registered under China’s updated national standards, helping companies understand how to apply the new rules in practice.
AKH Wien Becomes First Hospital In Austria Certified For Diversity Management
AKH Wien Becomes First Hospital In Austria Certified For Diversity Management
The Vienna General Hospital (AKH Wien) has become the first hospital in Austria to receive certification for its diversity management system,
FDA Schedules Town Hall On Risk Based Inspections Under New QMSR Framework
FDA Schedules Town Hall On Risk Based Inspections Under New QMSR Framework
The U.S. Food and Drug Administration (FDA) has announced a Town Hall on April 1, 2026, to explain how inspections of medical device manufacturers will change under its new Quality Management System Regulation (QMSR), with a focus on a risk-based approach.
Mountain Healthcare First In UK To Achieve ISO 15189 Accreditation For SARC Services
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
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
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
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),

Global News

AutoCarbon Certification Scheme Due in 2027 As Pilot Phase Begins
AutoCarbon Certification Scheme Due in 2027 As Pilot Phase Begins
The International Automotive Oversight Bureau (IAOB) has announced AutoCarbon,
ISO 14064-5 Introduces Guidance For Remote Verification Of Greenhouse Gas Data
ISO 14064-5 Introduces Guidance For Remote Verification Of Greenhouse Gas Data
The International Organization for Standardization (ISO) has introduced ISO 14064-5, which provides guidance on how to carry out verification and validation of greenhouse gas (GHG) data using remote techniques in digital environments.
ISO 9002 Revision Moves To Draft International Standard Stage
ISO 9002 Revision Moves To Draft International Standard Stage
The revision of ISO 9002 has entered the Draft International Standard (DIS) stage, with ISO/TC 176/SC 2, the ISO subcommittee responsible for quality systems, advancing the project into formal consultation. 
ISO 37304 Compliance Management Certification Standard Advances to Final Draft Stage
ISO 37304 Compliance Management Certification Standard Advances to Final Draft Stage
The International Organization for Standardization (ISO) has advanced ISO 37304 to the final draft international standard (FDIS) stage.
One Vote Tips Toward New Edition Of ISO/IEC 17065 Over Amendment
One Vote Tips Toward New Edition Of ISO/IEC 17065 Over Amendment
One vote has tipped the decision toward publishing a new edition of ISO/IEC 17065 instead of issuing a separate amendment, following a closely split ballot within the International Organization for Standardization (ISO).
Is ISO 25500 a Solution to Supply Chain Data Challenges?
Is ISO 25500 a Solution to Supply Chain Data Challenges?
ISO 25500, a draft series of standards from the International Organization for Standardization (ISO), is presented by the Electronic Commerce Code Management Association (ECCMA) as a possible way to address long-standing problems with unreliable data across global supply chains.
IFS Updates Food, Logistics, Broker And Pacsecure Doctrines To Clarify Certification Rules
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 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
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
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
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
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.
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