1).Īlthough the structure of ISO 13485 will expand from the current eight main clauses to ten, most of the QMS requirements should essentially remain the same. Annex L prescribes eight high-level clauses (Fig. The next revision to ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes will see the standard’s structure aligned with the Annex L requirements. Annex L’s purpose is to provide alignment and consistency of MSSs by providing a high-level structure common core text, as well as common terms and core definitions. ![]() ISO/IEC Directives Part 1 Annex L (formerly called Annex SL) stipulate how the International Organization for Standardization’s (ISO) Management System Standard (MSSs) should be written. By Mark Durivage, Quality Systems Compliance LLC
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