The auditors are expected to keep in mind that the standard requires six (6) mandatory procedures, such as with clauses 4.2.4, 4.2.5, 8.2.4, 8.3, 8.5.2, and 8.5.3. You will see questions on the checklist that refer to the standard, and for each clause, provisions are made for additional questions. The checklist is best used by trained and practicing auditors to evaluate or assess Quality Management Systems requirements based on the standard. Are audits reviewed at management review as a means to improve effectiveness? (5.6)ġ1.The ISO 13485:2016 Internal Audit Checklist This checklist is based on the information provided in the release of the ISO 13485:2016 international standard. Are corrective actions from internal audits closed in a timely manner? How many overdue actions are there? (8.5.2)ġ0. Is the audit programme on track (or have some audits been missed this year?) (8.2.4)ĩ. Are these records maintained? Are they up to date? (4.2.5) System Effectiveness & ImprovementĨ. Are records of internal audits maintained? (8.2.4)ħ. – Are actions then taken to address any non-conformances – addressing the cause and ensuring that the issue does not recur (8.5.2) Reporting & RecordsĦ. – How corrective actions are agreed, verified and followed up? – Nonconformity reporting – how is the achieved and what happens with the report? – Checklist preparation or similar as a means to record objective evidence? Review audit procedure (it must be documented) (8.2.4) does this cover: 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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