ISO 13485 Remains Unchanged:
Review Committee Rejects Alignment with Annex SL
Review Committee Rejects Alignment with Annex SL
The quality management standard for medical devices, ISO 13485, will remain in its current structure following the decision of the ISO Technical Committee ISO/TC 210 not to amend the standard or align it with Annex SL, the harmonised structure used for other ISO management system standards.
This decision confirms that ISO 13485, as a sector-specific standard designed for a highly regulated and controlled medical device environment, will retain its independent structure and established approach to quality management. Organisations certified to ISO 13485 may therefore continue to apply the existing requirements without anticipating structural changes.
ICS will continue to monitor the activities of the ISO Technical Committees and will keep its clients informed of any future developments or changes to relevant standards.
