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
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
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
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
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
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
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
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’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 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’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
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.
Accredia Passes EA Peer Evaluation for Biobanking Accreditation
The Italian accreditation body Accredia has passed a peer evaluation by the European co-operation for Accreditation (EA), advancing the process for international recognition of Italian biobank accreditations under ISO 20387.Global News
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
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
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
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.
GFSI Seeks Feedback on JFSM Recognition Under Benchmarking Requirements v2024
The Global Food Safety Initiative (GFSI) has opened a public stakeholder consultation on the Japan Food Safety Management Association (JFSM) application for recognition under GFSI Benchmarking Requirements Version 2024.
Chery Added as IATF's Third Asian Automotive Group Member
The International Automotive Task Force (IATF) has approved the addition of Chery Automobile, as a new member of IATF AISBL, making it the third Asian automotive group represented in the organization.
IFS Announces June Release of Progress Logistics Version 2
IFS will publish IFS Progress Logistics version 2 at the end of June, updating the program that helps companies prepare for IFS Logistics certification.
Third Cohort of Environmental Management Youth Leadership Group Kicks Off
The third cohort of the ISO Environmental Management (ISO/TC 207) Youth Leadership Group (YLG 3.0) has held its kick-off meeting, bringing together more than 45 participants from around 30 countries.
ISO 9606 Requirements for Welder Qualification Under Revision
The International Organization for Standardization (ISO) is revising ISO 9606, the international standard for qualification testing of welders performing fusion welding.
ISO 9001 Auditing Practices Group Releases First AI-Focused Guidance
The ISO 9001 Auditing Practices Group (APG) has published new guidance on auditing quality management systems that use artificial intelligence, marking the group's first publication dedicated specifically to AI.
ISO 10993-6 Standard for Implantation Testing Updated
The International Organization for Standardization (ISO) has published a revised edition of ISO 10993-6, expanding guidance for implantation studies used in the biological evaluation of medical devices.
