Management Systems World
All on Quality and other Standards in one place since 2010. Now Worldwide.
News Medicine / Pharmaceutical
Please note that you have to be a registered member with paid membership in order to see full articles.
RegisterSelected News
FDA Shifts Medical Device Inspections To Lifecycle-Based QMS Oversight
The U.S. Food and Drug Administration (FDA) has updated how it inspects medical device manufacturers, introducing a lifecycle‑based approach to quality management system oversight under its new Quality Management System Regulation.
Free Risk Tool Launched for Healthcare Information Security Standard NEN 7510
The Netherlands Standardization Institute (NEN) has launched a free risk analysis tool to help healthcare organizations and other entities that process personal health data carry out the information security risk assessment required under NEN 7510.
Hoan My International Hospital Laboratory Earns ISO 15189 Accreditation
The medical laboratory of Hoan My International Hospital has received ISO 15189:2022 accreditation from the National Accreditation Bureau (BoA),
EU Expands Laboratory Oversight for Highest Risk In Vitro Diagnostic Devices
The European Union (EU) has expanded oversight of Class D in vitro diagnostic medical devices under Regulation (EU) 2017/746, known as the In Vitro Diagnostic Regulation (IVDR).
BIS Seeks Public Feedback on Draft Standards for Medical Devices and Healthcare
The Bureau of Indian Standards (BIS), through its Medical Equipment and Hospital Planning Department,
NATA Seeks Experts in Software as Medical Devices and AI for Human Pathology Advisory Committee
The National Association of Testing Authorities, Australia (NATA) is inviting expressions of interest to join its Human Pathology Accreditation Advisory Committee,
Denmark Aligns Accreditation Rules for Referral Laboratories and Specialists With ISO 15189
Denmark has revised its national accreditation rules for the use of referral laboratories and external specialists to align with the Danish version of ISO 15189:2022 for medical laboratories.
FDA Aligns U.S. Device Rules With ISO 13485, Replaces QSR With QMSR
The U.S. Food and Drug Administration (FDA) has replaced its long-standing Quality System Regulation (QSR) with the new Quality Management System Regulation (QMSR), changing the legal framework for quality management in the U.S. medical device sector.
NEN Seeks Experts for Clinical Research Standards Committee
The Netherlands Standardization Institute (NEN) is inviting experts to join its Clinical Research standards committee to help shape international standards for clinical investigations of medical devices.
Clearlab Earns MDSAP, ISO 13485 and EU MDR Certifications for Contact Lenses
Clearlab, a manufacturer of vision correction products and lens care solutions, has obtained combined certification under the Medical Device Single Audit Program (MDSAP), ISO 13485, and the European Union Medical Device Regulation (EU MDR).
EU Medical Device Database EUDAMED Opens First Mandatory Modules
The European Commission has published the first four functional modules of EUDAMED, the EU database for medical devices and in vitro diagnostic devices.
Italy Launches Accreditation for ISO 7101 Healthcare Quality Systems
Italy has opened accreditation for certification bodies that audit healthcare organizations against UNI ISO 7101:2024, the standard for quality management in health services.Global News
July 15 Deadline Nears for GMP+ Certificates Issued by DNV Italy and LL-C
GMP+ International has warned companies GMP+ Feed certificates issued by DNV Business Assurance Italy S.R.L. or LL-C Certification Czech Republic a.s. that
ISO 9000 and ISO 19011 Revised: New Guidance for Quality and Auditing
Two cornerstone standards for quality management and auditing have been revised, with the International Organization for Standardization (ISO) publishing new editions of ISO 9000 and ISO 19011.
ISO 9002 Revision Reaches Public Comment Stage
The International Organization for Standardization (ISO) has advanced the revision of ISO 9002 to the Draft International Standard (DIS) stage, opening the project for wider review and feedback.
Global ACI Sets 36-Month Transition for ISO/IEC 17024:2026
The Global Accreditation Cooperation Incorporated (Global ACI) has established a 36-month transition period for ISO/IEC 17024:2026, the newly revised international standard for bodies that certify individuals.
PAS 96:2026 Updates Food Defence Guidance for Emerging Threats
The British Standards Institution (BSI) has published PAS 96:2026, a fully revised edition of its food defence guide.
BRCGS Updates Meat Supply Chain Assurance Module
The British Retail Consortium Global Standards (BRCGS) has updated its Additional Module 11: Meat Supply Chain Assurance.
ISO 29997 Offers First International Framework for Quality Internships
ISO 29997:2025 provides the first international framework designed to help organizations deliver higher-quality internships through clearer planning, management and evaluation practices.
Experts Behind ISO 14001:2026 Explain New Focus on Climate, Biodiversity and Results
The International Organization for Standardization (ISO) has outlined the most important changes in ISO 14001:2026,
New ISO/IEC 15408 and 18045 Editions Update Common Criteria Framework
ISO/IEC 15408-1:2026 and ISO/IEC 18045:2026 have been published, updating the Common Criteria framework, an international system used to evaluate the security of IT products.
FDA Partially Recognizes ISO 10993-1:2025 for Medical Devices
The U.S. Food and Drug Administration (FDA) has partially recognized ISO 10993-1:2025, the latest edition of the international standard used to assess the biological safety of medical devices.
Licensing Instead of Sales: ISO Changes How Standards Are Used
The International Organization for Standardization (ISO) is preparing to replace its traditional standards sales approach with a licensing model that would give users defined rights to use standards content instead of broad unrestricted access.
