This quality system audits procedure is intended to meet the requirement for an internal auditing procedure in accordance with ISO 13485:2016, Clause 8.2.4 and 21 CFR 820.22.
Quality System Audits Procedure Summary
This 9-page quality system audits procedure meets the requirements for clause 8.2.4 of ISO 13485:2016 and 21 CFR 820.22 for conducting internal quality system audits. The procedure is in its eighth draft, and the latest draft includes much more detail regarding methods for conducting an audit, the responsibilities of lead auditors and audit team members, and the requirements for auditor training, training effectiveness, and competency. The following forms and lists are associated with this procedure:
- LST-007 Audit Log or Schedule
- TMP-003 Supplier / Internal Audit Report Template
- TMP-035 Opening & Closing Meeting Checklist
This updated procedure may also be applied to remote auditing. However, a work instruction for remote auditing (WI-002) is sold separately as part of our remote auditing webinar. The section on auditor and lead auditor competency includes provisions for retrospective review of competency via recorded remote auditing.
The procedure does not apply to supplier quality audits, which are managed through the Supplier Quality Management Procedure (SYS-011). However, the requirements for training, training effectiveness, and competency of 2nd party auditors are covered in the quality system audits procedure. The schedule for supplier quality audits may also be documented in the Audit Log (LST-007).
Cross-reference to audit criteria
This procedure was updated to include references to the applicable ISO 13485:2016 clauses, and color-coding was added by Matthew Walker to facilitate auditors identifying where the requirements for each sub-clause are found. The procedure also explains where the requirements for monitoring and measurement of processes can be found for each process.
Additional Quality System Audits Procedure Training
If you are interested in learning more about the process approach to auditing and adjacent link auditing, please see our webinar on the process approach to auditing.
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