News Medical Products & Pharmaceuticals


Selected News

RvA Gains European Recognition for EN ISO 20387 Biobank Accreditation
RvA Gains European Recognition for EN ISO 20387 Biobank Accreditation
The Dutch Accreditation Council (RvA) has gained European recognition for its EN ISO 20387 biobank accreditation activity, after the standard was added to its European co-operation for Accreditation (EA) Multilateral Agreement (MLA) scope.
NIST and NIH Seek Input on Future Medical Measurement Standards
NIST and NIH Seek Input on Future Medical Measurement Standards
The U.S. government is seeking public input on future measurement and standards needs for medical imaging, devices, diagnostics and therapy.
Erasmus MC Receives Netherlands’ First Biobank Accreditation
Erasmus MC Receives Netherlands’ First Biobank Accreditation
The Dutch Accreditation Council (RvA) has granted the Netherlands’ first biobank accreditation to Erasmus MC Central Biobank & Trialsupport.
Saudi Arabia Takes Secretariat of New ISO/TC 357 on Wound Dressings
Saudi Arabia Takes Secretariat of New ISO/TC 357 on Wound Dressings
Saudi Arabia will hold the secretariat of the newly created International Organization for Standardization (ISO) technical committee ISO/TC 357, which will develop international standards for wound dressings and compresses.
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.
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.
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),
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.
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,

Global News

ISO Survey 2025 Shows Global Certification Growth, With Unusually Sharp Rise in India
ISO Survey 2025 Shows Global Certification Growth, With Unusually Sharp Rise in India
The International Organization for Standardization (ISO) has released the 2025 ISO Survey, reporting more than 3.28 million valid management system certificates worldwide.
AIAG Updates Guidelines for Supplier Management and Electronic Assembly
AIAG Updates Guidelines for Supplier Management and Electronic Assembly
The Automotive Industry Action Group (AIAG) has released updated editions of two Continuous Quality Improvement (CQI) guidelines covering supplier management and electronic assembly manufacturing.
IEC 62366-3 for AI Medical Device Usability Reaches Committee Draft Stage
IEC 62366-3 for AI Medical Device Usability Reaches Committee Draft Stage
A proposed technical specification providing guidance on usability engineering for medical devices using artificial intelligence (AI) and machine learning (ML), IEC 62366-3, has reached the committee draft stage.
ISO/IEC 27017:2026 Updates Information Security Controls for Cloud Services
ISO/IEC 27017:2026 Updates Information Security Controls for Cloud Services
ISO and IEC have published ISO/IEC 27017:2026, an updated international standard providing guidance on information security controls for cloud services.
ISO Seeks Feedback on Draft ISO 56011 for Innovation Management Competencies
ISO Seeks Feedback on Draft ISO 56011 for Innovation Management Competencies
ISO/DIS 56011, a draft international standard outlining the knowledge, skills, and behaviors needed to manage innovation effectively, is now open for feedback.
ISO Publishes New Guide on Education About Standardization Around the World
ISO Publishes New Guide on Education About Standardization Around the World
The International Organization for Standardization (ISO) has published Education about Standardization: Perspectives and Practices (PUB100508), a new guide exploring how standards are being integrated into education systems worldwide.
ISO/IEC 9837:2026 Establishes Common Concepts for Systems Resilience
ISO/IEC 9837:2026 Establishes Common Concepts for Systems Resilience
ISO/IEC 9837:2026, a new international standard on systems resilience, provides a common basis for understanding how systems can withstand disruptions, adapt to adverse conditions, and recover from failures.
2026 Deming Prize Winners Announced
2026 Deming Prize Winners Announced
The Deming Prize Committee announced the 2026 winners on October 6, recognizing two individuals for their contributions to quality management and four organizations from Japan, India, and Indonesia.
Draft ISO/IEC 42007 Sets Framework for AI Conformity Assessment Schemes
Draft ISO/IEC 42007 Sets Framework for AI Conformity Assessment Schemes
ISO and IEC are developing ISO/IEC DIS 42007, a framework for conformity assessment schemes for artificial intelligence (AI) systems.
ISO Approves Development of Innovation Management Guidance for Startups and SMEs
ISO Approves Development of Innovation Management Guidance for Startups and SMEs
The International Organization for Standardization (ISO) has approved a new project to develop innovation management guidance for startups and small and medium-sized enterprises (SMEs).
BRCGS Consumer Products Issue 5 Set for Launch at Connect Americas
BRCGS Consumer Products Issue 5 Set for Launch at Connect Americas
BRCGS will launch Consumer Products Issue 5 at BRCGS Connect Americas in Nashville on October 13, 2026, introducing a revised certification standard for consumer product manufacturers. Audits against the new edition will begin on June 1, 2027.
GRI Begins Developing Sustainability Reporting Standard for Food and Beverages
GRI Begins Developing Sustainability Reporting Standard for Food and Beverages
The Global Reporting Initiative (GRI) has begun developing a new Sector Standard for food and beverage companies, covering sustainability impacts across their own operations and value chains.
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