News Medicine / Pharmaceutical


Selected News

Topolšica Hospital Achieves Slovenia's First ISO 7101 Certification
Topolšica Hospital Achieves Slovenia's First ISO 7101 Certification
Topolšica Hospital has become the first medical institution in Slovenia to earn the ISO 7101 certification for management systems for quality in healthcare organizations.
How EU’s Unique Device Identification Enhances Medical Device Safety
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.
ISBIH Translates ISO 15189 Standard for Medical Laboratories
ISBIH Translates ISO 15189 Standard for Medical Laboratories
The Institute for Standardization of Bosnia and Herzegovina (ISBIH) has translated the latest edition of the international standard Medical Laboratories—Requirements for Quality and Competence, and issued it as BAS EN ISO 15189:2022.
Dutch Standard on Ultraviolet Sterilization of Medical Devices Open for Comments
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.
Netherlands Updates Standard for IT Security in Healthcare
Netherlands Updates Standard for IT Security in Healthcare
The updated Dutch standard for information security in healthcare is now available on the NEN Connect, the platform of the Netherlands' national standards organization.
Fourth Edition of Swedish Handbook for Medical Gas Facilities Published
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.
EU’s QUANTUM Project Aims to Create a Standardized Health Data Quality and Utility Label
EU’s QUANTUM Project Aims to Create a Standardized Health Data Quality and Utility Label
The QUANTUM project is an initiative that aims to create a standardized health data quality and utility label for the secondary use of health data across the EU.
Swedac Conducts First Assessments Under Updated ISO 15189 Standard
Swedac Conducts First Assessments Under Updated ISO 15189 Standard
The 2022 version of the ISO 15189 standard has been implemented, and Swedac began inspections of medical laboratories against it in January 2024.
Standard for Auditing Healthcare Quality Management Systems Released in Serbian
Standard for Auditing Healthcare Quality Management Systems Released in Serbian
A new standard specifying competency requirements for auditing and certifying quality management systems in healthcare organizations has been published in Serbian.
Nigeria’s Healthcare Sector Leverages ISO Certifications to Reverse Medical Tourism
Nigeria’s Healthcare Sector Leverages ISO Certifications to Reverse Medical Tourism
Nigeria’s healthcare system is taking strides to retain local patients and curb outbound medical tourism by implementing ISO 9001 Quality Management Systems (QMS) and ISO 15189 for medical laboratory competence.
AFNOR can now issue CE Marking certificates for Medical Devices. Looking for Auditors
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.
Montenegro Hosts Roundtable on Medical Laboratory Accreditation
Montenegro Hosts Roundtable on Medical Laboratory Accreditation
The Accreditation Body of Montenegro (ATCG) hosted a roundtable focused on the role and significance of medical laboratory accreditation.

Global News

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.
ISO/TS 19384 Sets First Standard for Digital Service Excellence
ISO/TS 19384 Sets First Standard for Digital Service Excellence
The International Organization for Standardization (ISO) has released ISO/TS 19384:2026,
FSSC Issues Five Sector-Specific Guides for Development Program Implementation
FSSC Issues Five Sector-Specific Guides for Development Program Implementation
The Foundation for Food Safety Certification (FSSC) has published five sector-specific guidance documents to support organizations using the FSSC Development Program,
ISO 14001 Fourth Edition Officially Released
ISO 14001 Fourth Edition Officially Released
The International Organization for Standardization (ISO) has published ISO 14001:2026, marking the release of the fourth edition of the world’s most widely used environmental management systems standard. 
Global ACI Introduced: IAF and ILAC Successor Presents New Identity
Global ACI Introduced: IAF and ILAC Successor Presents New Identity
A new international accreditation body, Global Accreditation Cooperation Incorporated, has introduced a new identity as Global ACI, including a logo and communication channels after starting operations on January 1, 2026.
ISO 17067 Revision Expands Conformity Assessment Schemes
ISO 17067 Revision Expands Conformity Assessment Schemes
The International Organization for Standardization (ISO) Committee on Conformity Assessment (CASCO) is revising ISO/IEC 17067 to expand its scope from product certification to a broader framework for conformity assessment schemes.
ISO Establishes Working Group on Environmental and Social Impact Data in Agrifood Systems
ISO Establishes Working Group on Environmental and Social Impact Data in Agrifood Systems
The International Organization for Standardization (ISO) has set up a new working group under ISO/TC 347 to develop a standardized way to record and share data on environmental and social impacts across agrifood supply chains.
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.
We use Cookies