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 (SYS-021) Webinar Bundle
SYS-021 Quality Audits ProcedureSYS-021 Quality Audits Procedure - this includes a procedure, forms, and a webinar as a bundle.Price: $299.00
When is the Webinar about this Quality System Audits Procedure?
This webinar was live on Monday, July 8, 2024. The webinar has been recorded. You can purchase it on-demand and watch the training as often as you wish. You will also receive access to updates free of charge with your purchase.
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download (including your spam folder). The YouTube webinar above is outdated. The current list of content is listed below.
Quality System Audits Procedure Summary
This 10-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 ninth 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:
- FRM-034 Internal Audit Schedule (MS Excel)
- FRM-035 ISO 13485:2016 Clause Traceability Matrix (MS Word)
- FRM-043 Audit Report Review Checklist (MS Word)
- LST-007 Audit Log or Schedule (MS Excel)
- SYS-021 Quality Auditing Procedure Webinar (MS PPT)
- TMP-003 Supplier / Internal Audit Report Template (MS Word)
- TMP-035 Opening & Closing Meeting Checklist (MS Word)
- TMP-036 Opening Meeting and Closing Meeting Template (MS PPT)
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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To review a sample Medical Device Academy procedure click below:
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.