Sample ISO 9001 Quality Manual - ASQ
In addition, new PTs and LLTs - including relevant terms for manufacturing and quality system issues that are not currently represented in MedDRA - will be added to the hierarchy through the ongoing Change Request process. See the table below for the proposed hierarchy. Primary SOC: HLGT; HLT; Notes; Product issues. New SOC . Device issues. HLGT moved from SOC . General disorders and ... ................
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