News Medicine / Pharmaceutical


Selected News

EN ISO 27799:2026 Wins SBS Standard of the Year 2025 for Supporting SMEs
EN ISO 27799:2026 Wins SBS Standard of the Year 2025 for Supporting SMEs
Small Business Standards (SBS) has named EN ISO 27799:2026 its Standard of the Year 2025 for helping small and medium-sized enterprises (SMEs) implement healthcare information security.
NEN Invites Stakeholders to Shape Standards Agenda for Sustainable Medical Devices
NEN Invites Stakeholders to Shape Standards Agenda for Sustainable Medical Devices
The Royal Netherlands Standardization Institute (NEN) is inviting healthcare organizations, manufacturers, government bodies, researchers and other stakeholders to help develop a national standardization agenda for sustainable medical devices.
DIN SPEC 91494 Brings Spiritual Care Into Healthcare Management
DIN SPEC 91494 Brings Spiritual Care Into Healthcare Management
The German Institute for Standardization (DIN) has published DIN SPEC 91494, Germany's first specification providing healthcare organizations with a structured framework for integrating Spiritual Care into existing quality management systems.
TGA Proposes Publishing Therapeutic Goods GMP Inspection Outcomes
TGA Proposes Publishing Therapeutic Goods GMP Inspection Outcomes
The Therapeutic Goods Administration (TGA) has opened a consultation on plans to publish Good Manufacturing Practice (GMP) inspection outcomes and GMP certificates for therapeutic goods manufacturers, seeking feedback on how the information should be published and accessed.
Norway Reestablishes Medical Device Standards Committee, Invites New Members
Norway Reestablishes Medical Device Standards Committee, Invites New Members
Standard Norway (SN) has reestablished its national committee for medical device management systems and is now inviting more professional communities to participate in work on international and European standards for quality and risk management in medical devices.
Joint Commission Launches Healthcare Cyber Resilience Program With Future Certification Pathway
Joint Commission Launches Healthcare Cyber Resilience Program With Future Certification Pathway
The Joint Commission, a U.S. healthcare accreditation body, and the American Hospital Association (AHA) have launched a new Cyber Resilience Readiness (CRR) program for healthcare organizations.
PCA Opens Consultation on Revised Biobank Accreditation Program
PCA Opens Consultation on Revised Biobank Accreditation Program
Polish Centre for Accreditation (PCA) has opened a public consultation on a revised version of its DABB-01 accreditation program for biobanks, introducing clearer rules for accreditation scope descriptions and updates aligned with PN-EN ISO 20387:2021-01.
Vietnam Food Safety Institute Achieves GLP-OECD Status
Vietnam Food Safety Institute Achieves GLP-OECD Status
The National Accreditation Office for Quality (BOA) awarded OECD Good Laboratory Practice (GLP) recognition to the National Institute for Food Control (NIFC),
Italy Adopts ISO 22367:2026 for Medical Laboratory Risk Management
Italy Adopts ISO 22367:2026 for Medical Laboratory Risk Management
The Italian National Standardization Body (UNI) has published the Italian adoption of ISO 22367:2026, the revised international guidance standard for risk management in medical laboratories.
Dutch Initiative Prepares New Committee on Medical Device Environmental Impact
Dutch Initiative Prepares New Committee on Medical Device Environmental Impact
The Royal Netherlands Standardization Institute (NEN) is preparing a new committee focused on methods for assessing the environmental impact of medical devices, with the aim of helping shape Dutch input into future European and international standardization work.
Mexico Updates Medical Device Labeling Standard With New Safety and Digital Information Rules
Mexico Updates Medical Device Labeling Standard With New Safety and Digital Information Rules
Mexico’s Ministry of Health has published a revised version of NOM-137-SSA1-2024, the national standard that sets labeling requirements for medical devices sold in the country.
Sorsix Becomes First in Europe’s Public Health Sector to Earn ISO 42001 Certification
Sorsix Becomes First in Europe’s Public Health Sector to Earn ISO 42001 Certification
Sorsix has become the first organization in Europe to have governance for a live national healthcare system certified under ISO/IEC 42001, the international standard for AI management systems.

Global News

VDA Releases ISA 2027 Information Security Assessment Catalogue for TISAX
VDA Releases ISA 2027 Information Security Assessment Catalogue for TISAX
The German Association of the Automotive Industry (VDA) has published ISA 2027, the next version of the Information Security Assessment (ISA) catalogue used by TISAX, an information security assessment and exchange mechanism for the automotive industry. 
Global Standards Updates Flagship GOTS Standard to Version 8.1
Global Standards Updates Flagship GOTS Standard to Version 8.1
The Global Standards (GS) has updated the Global Organic Textile Standard (GOTS) to Version 8.1, its first revision since the major Version 8.0 release in March.
TÜV SÜD Acquires SustainCERT to Accelerate Digital Carbon Verification
TÜV SÜD Acquires SustainCERT to Accelerate Digital Carbon Verification
Germany-based testing, inspection and certification company TÜV SÜD has acquired climate verification platform SustainCERT
ISO 30201 Adds Human Resources to the ISO Management System Family
ISO 30201 Adds Human Resources to the ISO Management System Family
The International Organization for Standardization (ISO) has published ISO 30201:2026, the first international requirements standard for human resources management systems.
ISO/PAS 25171 Provides First International Auditing Guide for ISO 21001 Educational Management Systems
ISO/PAS 25171 Provides First International Auditing Guide for ISO 21001 Educational Management Systems
The International Organization for Standardization (ISO) has published ISO/PAS 25171:2026, the first international guidance for auditing educational organization management systems under ISO 21001:2025.
Proposal Calls for ISO Committee on Responsible Business Practices and Sustainability Reporting
Proposal Calls for ISO Committee on Responsible Business Practices and Sustainability Reporting
An International Organization for Standardization (ISO) technical committee has been proposed to develop standards for responsible business practices and sustainability reporting.
CanadaGAP Version 11 Achieves GFSI Recognition Under 2024 Benchmark
CanadaGAP Version 11 Achieves GFSI Recognition Under 2024 Benchmark
The Global Food Safety Initiative (GFSI) has recognized CanadaGAP Food Safety Program Version 11.0 against its 2024 Benchmarking Requirements (BMRs), allowing
ISO 9001:2026 Receives Final Approval Ahead of September Publication
ISO 9001:2026 Receives Final Approval Ahead of September Publication
The International Organization for Standardization (ISO) has approved the final draft of ISO 9001:2026 with overwhelming support, clearing the way for publication of the revised quality management standard, which is expected in September 2026.
Codex Defines When 'May Contain' Allergen Labels Are Justified
Codex Defines When 'May Contain' Allergen Labels Are Justified
New international guidance adopted by the Codex Alimentarius Commission aims to make 'may contain' allergen labels more consistent and trustworthy.
ISO 14025:2026 Brings First Major Update to Environmental Product Declarations in 20 Years
ISO 14025:2026 Brings First Major Update to Environmental Product Declarations in 20 Years
The International Organization for Standardization (ISO) has published ISO 14025:2026, the first major revision of the international standard for Environmental Product Declarations (EPDs) since 2006. 
ISO/IEC 27000 Updated With Clearer Guidance for Information Security Standards
ISO/IEC 27000 Updated With Clearer Guidance for Information Security Standards
ISO and IEC have updated ISO/IEC 27000, the guide to the ISO/IEC 27000 family of information security standards.
AIAG and VDA Publish Global Guide for Better Manufacturing Process Control
AIAG and VDA Publish Global Guide for Better Manufacturing Process Control
A new joint manual from the Automotive Industry Action Group (AIAG) and the German Association of the Automotive Industry (VDA) establishes a single international approach to monitoring and improving manufacturing processes.
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