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  • merzkrashed replied to the topic "Internal Audits for small organizations"6 years, 1 month ago

    Hi thuytienlecao Internal audits could be done by the manufacturer itself or by hiring auditor.Both 21 CFR Part 820, the Quality System Regulation (QSR), and ISO 13485:2003 require internal quality audits. In QSR, the audits have two primary purposes: Assure…   Read more»