Are auditors competent? Check training certificates/records. Does the programme reflect the results of previous audits & importance of process? (8.2.4)Ĥ. Does the audit programme cover all processes & clauses of ISO 13485? (8.2.4 a and b)ģ. Is there an audit programme available, approved and communicated?(8.2.4)Ģ. Here is a checklist that will allow you to thoroughly audit your ISO 13485 internal audit system. This allows you to show that the system if fully implemented and effective.
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