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alexandrabuga replied to the topic Quality Management System Documentation Hierarchy in the forum Device Documentation 7 years, 3 months ago
I haven’t worked at company that directly deals with this, but I think you can call any document anything so the importance is the content of the documentation. I think the necessary documentation/titles would be what we encountered in this week’s simulation. With at the top of the Quality Manual (QM) which is the document that explains how the Quality System will run, like how the materials will be inspected and how their acceptance/rejection need to be documented. The Quality System Procedures (QSPs) explain what will be done in order to fulfill the QM and is described at high level including how each material will have its own Work Instruction. Then the Work Instructions/SOPs which will set how to perform a task that details how the material will be inspected and what do with it after its accepted/rejected and then the SPEC document. Overall I think as long as the content is covered it doesn’t really matter the exact title of the documents but I agree the general hierarchy and content is necessary, especially as @gp232 mentions the FDA were to audit.