News Medicine / Pharmaceutical


Selected News

Mexico Recognizes MDSAP as Equivalent to National Medical Device GMP
Mexico Recognizes MDSAP as Equivalent to National Medical Device GMP
Mexico has issued a new interpretation rule for the NOM-241-SSA1-2025 standard on good manufacturing practices (GMP) for medical devices, confirming that
Dutch In Vitro Standards Committee Presents Broad Agenda for New Laboratory Standards
Dutch In Vitro Standards Committee Presents Broad Agenda for New Laboratory Standards
The Dutch In Vitro Diagnostics Standards Committee is driving a wide range of international work on new laboratory and diagnostic standards, reflecting the rapid rise of digital tools, artificial intelligence, and smarter testing systems.
Standard Norway to Establish National Committee on Medical Device Standards
Standard Norway to Establish National Committee on Medical Device Standards
Standard Norway (SN) is creating a new national mirror committee, SN/K 113, to contribute to international standardization on quality management for medical devices.
Sweden Moves to Standardize Medicine Dispenser APIs
Sweden Moves to Standardize Medicine Dispenser APIs
Sweden has launched work on a national standard for Application Programming Interfaces (APIs) used in automated medicine dispensers.
Serbian Pharma Conference Explores Digital Transformation of GxP Activities
Serbian Pharma Conference Explores Digital Transformation of GxP Activities
The Chamber of Commerce and Industry of Serbia (PKS) hosted a professional conference on October 30 focusing on the digitalization of GxP (Good Practice) activities across the supply chain for human medicines.
Standardizing Hospital Design Terminology with New UNI 11993
Standardizing Hospital Design Terminology with New UNI 11993
Italy’s national standards body UNI has published UNI 11993, a new standard that defines terminology for hospital and healthcare structures to
CEN Launches Development of EN 17483-5 on Health Security Services
CEN Launches Development of EN 17483-5 on Health Security Services
The European Committee for Standardization (CEN) has begun work on EN 17483-5, a new standard focusing on health security services for the healthcare sector.
IQTIG Updates List of Healthcare Certificates and Quality Seals for German Federal Hospital Atlas
IQTIG Updates List of Healthcare Certificates and Quality Seals for German Federal Hospital Atlas
The Institute for Quality Assurance and Transparency in Healthcare (IQTIG) has published an updated list of certificates and quality seals for inpatient healthcare providers.
ABNT Launches ISO 7101 to Advance Quality in Health Organizations
ABNT Launches ISO 7101 to Advance Quality in Health Organizations
The Associação Brasileira de Normas Técnicas (ABNT) has officially launched the Brazilian version of ISO 7101,
Inacal Creates New Technical Committee to Improve Health Sector Management in Peru
Inacal Creates New Technical Committee to Improve Health Sector Management in Peru
The National Institute for Quality (Inacal) in Peru has launched a new Technical Standardization Committee focused on the management of healthcare organizations.
Indonesia Makes Halal Certification Compulsory for Imported Food and Beverages by 2026
Indonesia Makes Halal Certification Compulsory for Imported Food and Beverages by 2026
Starting October 17, 2026, Indonesia will require halal certification for imported food and beverages,
First in Scotland: NHS Tayside Audiology Accredited Under IQIPS Standard
First in Scotland: NHS Tayside Audiology Accredited Under IQIPS Standard
NHS Tayside’s Audiology Department has become the first in Scotland to achieve accreditation under the Improving Quality in Physiological Services (IQIPS) standard from the United Kingdom Accreditation Service (UKAS).

Global News

European AI Standard for Computer Vision prEN 18281 Enters Public Enquiry
European AI Standard for Computer Vision prEN 18281 Enters Public Enquiry
A European draft standard, prEN 18281, for evaluating AI systems that analyze images and video has entered public enquiry, setting out how such systems should be assessed as part of the broader framework supporting the EU AI Act.
Work Begins on IEC 60601-1 Medical Electrical Equipment Safety Standard Update
Work Begins on IEC 60601-1 Medical Electrical Equipment Safety Standard Update
The International Electrotechnical Commission (IEC) has begun work on updating IEC 60601-1, the core standard for the safety and essential performance of medical electrical equipment.
ISSB Proposes Updates to Three SASB Standards, Refining Sustainability Reporting in Agriculture, Food and Power
ISSB Proposes Updates to Three SASB Standards, Refining Sustainability Reporting in Agriculture, Food and Power
The International Sustainability Standards Board (ISSB) has issued a consultation on proposed amendments to three Sustainability Accounting Standards Board (SASB) Standards to support alignment with IFRS S1 and IFRS S2,
FSC Proposes New Approach To Intact Forest Landscapes Protection
FSC Proposes New Approach To Intact Forest Landscapes Protection
The Forest Stewardship Council (FSC) has launched two public consultations on draft Advice Notes to strengthen how Intact Forest Landscapes (IFLs) are managed and protected.
VDA Releases Automotive SPICE Yellow Volume 3rd Revised Edition for Public Review
VDA Releases Automotive SPICE Yellow Volume 3rd Revised Edition for Public Review
The German Association of the Automotive Industry (VDA) Quality Management Center (QMC) has released the Automotive SPICE Yellow Volume 3rd revised edition, opening a public feedback period until May 12, 2026.
Technical Guides Explain 2026 Updates to ISO 9001 and ISO 14001
Technical Guides Explain 2026 Updates to ISO 9001 and ISO 14001
Global certification body Bureau Veritas has released two technical guides on the revised versions of ISO 9001 and ISO 14001,
VDA 20 Guide on AI in Quality Management Opens for Feedback
VDA 20 Guide on AI in Quality Management Opens for Feedback
The German Association of the Automotive Industry (VDA) has released VDA 20 – AI in Quality Management as a draft document and opened it for public feedback until June 30, 2026,
ISO 14155 on Clinical Investigations of Medical Devices in Humans Updated
ISO 14155 on Clinical Investigations of Medical Devices in Humans Updated
The International Organization for Standardization (ISO) has published ISO 14155:2026, updating the global Good Clinical Practice standard for clinical investigations of medical devices in human subjects.
ISO 17024 Third Edition Published: Updated Rules For Certification Of Persons
ISO 17024 Third Edition Published: Updated Rules For Certification Of Persons
The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) have published the third edition of ISO/IEC 17024,
ISO 12100 Machinery Safety Revision Stalls Over Risk Definition Dispute
ISO 12100 Machinery Safety Revision Stalls Over Risk Definition Dispute
The revision of  ISO 12100, the core standard for machinery safety, remains unresolved following a negative international vote, with key disagreements, including on alignment with EU requirements. 
 
Sweden Introduces CBAM Accreditation for Emissions Verifiers, Reflecting Broader Global Shift in Climate Data Assurance
Sweden Introduces CBAM Accreditation for Emissions Verifiers, Reflecting Broader Global Shift in Climate Data Assurance
The Swedish Board for Accreditation and Conformity Assessment (SWEDAC) has introduced a new accreditation area for organizations verifying emissions data under the
Youth Leadership Program Opens Applications For 2026–2027 Environmental Cohort
Youth Leadership Program Opens Applications For 2026–2027 Environmental Cohort
Applications are now open for the third cohort of the Environmental Management Youth Leadership Group (YLG 3.0), an initiative of the International Organization for Standardization (ISO).
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