News Medicine / Pharmaceutical


Selected News

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.
Indonesia Revises Good Cosmetic Manufacturing Practice Certification Rules
Indonesia Revises Good Cosmetic Manufacturing Practice Certification Rules
Indonesia’s National Agency of Drug and Food Control (BPOM) has issued new rules for Good Cosmetic Manufacturing Practice (CPKB) certification,
Inmetro Opens Pilot Accreditation Program for Brazilian Biobanks
Inmetro Opens Pilot Accreditation Program for Brazilian Biobanks
The National Institute of Metrology, Quality and Technology (Inmetro) has opened applications for a pilot accreditation program for biobanks in Brazil based on ISO 20387.

Global News

SIS Opens Draft ISO 9002 for Public Comment
SIS Opens Draft ISO 9002 for Public Comment
The Swedish Institute for Standards (SIS) has opened public access to the draft version of ISO 9002, allowing organizations and quality professionals to read and comment on the official guidance for applying ISO 9001 before the document is finalized.
Busy Week Brings Four Automotive Quality Updates
Busy Week Brings Four Automotive Quality Updates
It has been a busy week for automotive quality, with four significant updates released for the sector.
ISO 33400:2026 Sets International Vocabulary for Reference Materials
ISO 33400:2026 Sets International Vocabulary for Reference Materials
The International Organization for Standardization (ISO) has published ISO 33400:2026, updating the international vocabulary for reference materials (RM) and certified reference materials (CRM).
TIC Council Backs ISO 14019 as Framework for Sustainability Assurance
TIC Council Backs ISO 14019 as Framework for Sustainability Assurance
The International Association for Testing, Inspection and Certification (TIC Council) has published a paper urging policymakers to recognize the ISO 14019 series as the framework for sustainability assurance,
IFS Updates Progress Scoring Guide for Food and Logistics Programs
IFS Updates Progress Scoring Guide for Food and Logistics Programs
International Featured Standards (IFS) has updated its Progress Scoring System brochure following the recent launch of IFS Progress Logistics 2.
CQI Announces International Quality Awards 2026 Winners
CQI Announces International Quality Awards 2026 Winners
The Chartered Quality Institute (CQI) announced the winners of the International Quality Awards 2026 during the Quality Live event in London on June 25,
IAQG Centralizes Aerospace Auditor Authentication
IAQG Centralizes Aerospace Auditor Authentication
The International Aerospace Quality Group (IAQG) has centralized the authentication of aerospace quality management system auditors, replacing the previous network of independent Auditor Authentication Bodies (AABs).
FSC Revised Trademark Standard Takes Effect
FSC Revised Trademark Standard Takes Effect
The Forest Stewardship Council (FSC) has launched a new online training course to support implementation of its revised trademark standard, FSC-STD-50-001 V3-0, which takes effect on July 1, 2026. 
SIS Offers Free Access to ISO 45001 Draft
SIS Offers Free Access to ISO 45001 Draft
The Swedish Institute for Standards (SIS) has made the proposed second edition of ISO 45001 - draft available for free download and public review,
 
ISO/DIS 9002 Ballot Opens for Comment
ISO/DIS 9002 Ballot Opens for Comment
The International Organization for Standardization (ISO) has released ISO/DIS 9002 for ballot, opening the international comment period on the revision of the guidance standard for applying ISO 9001. 
Public Consultation Opens on ISO 14060, First International Standard for Net Zero Alignment
Public Consultation Opens on ISO 14060, First International Standard for Net Zero Alignment
ISO 14060, the first international standard for net zero alignment, has entered public consultation.
EU Approves EN ISO 15223-1 for Medical Device and IVD Labeling
EU Approves EN ISO 15223-1 for Medical Device and IVD Labeling
The European Commission (EC) has approved EN ISO 15223-1, the standard used for symbols on medical device and in vitro diagnostic (IVD) labeling, for use in demonstrating compliance with EU requirements for these products.
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