Management Systems World
All on Quality and other Standards in one place since 2010. Now Worldwide.
ISO 13485 Stays Unchanged as Revision Committee Rejects Annex SL Alignment
November 5, 2025
You are not permitted to access this page. Please purchase membership to get full access to all articles.
Become a Member
Source: Management Systems World
The medical device quality management standard ISO 13485 will remain unchanged, as ISO’s Technical Committee in charge, ISO/TC 210, decided not to align it with Annex SL, ISO’s harmonized structure
Most popular news
-
ISO 9001 Revision: Draft International Standard Published, Public Inquiry StartsSeptember 2, 2025TÜRKAK Launching All-Encompassing Online Monitoring of Certification Audits via TBDSDecember 18, 2024Croatian Standards Institute Honors Top Contributors With Annual Certificates of AppreciationDecember 2, 2024KATS Moves Ahead with Next Phase of Strategy to Streamline Technical RegulationsFebruary 5, 2025ISO 13485 Under Review as Industry Prepares for Potential RevisionJune 25, 2025Final Weeks Before Transition Deadline for ISO 27001: Act by End of OctoberOctober 8, 2025ISO 42006 Brings Clear Requirements for Auditing AI Management SystemsJuly 9, 2025Latest Part of ISO 19650 Series Covers Health and Safety Information in BIMSeptember 2, 2025Brazil Invites Feedback on Revision of ABNT NBR 10004-2 Waste Classification StandardSeptember 17, 2025ISO 9001 Revision Shall Reach Ballot StageAugust 5, 2025
