The Virtual / Remote Compliance Audit
The following three posts address an approach to virtual / remote internal or vendor audits; starting with the final report, then the conduct of the Audit, then back to the Audit Plan. Use a video conferencing app, solicit key documents in e-form prior to audit. Then follow the Audit Plan with a discussion of each element with the team, requesting any supporting documentation in e-format, or similar, camera pix, or similar.
Remote / Virtual Audits - Internal or Vendor Audits - The Final Audit Report
ISO 13485 COMPLIANCE AUDIT REPORT
CONFIDENTIAL
Prepared For:
Site Audited (Remote /
Virtual):
___________________________________________________________________________
J.E.LINCOLN and Associates
LLC phone
435-840-0252
P O Box 2786
St George UT 84771-2876 www.jelincoln.com
e-mail jel@jelincoln.com
COMPLIANCE AUDIT REPORT
CONFIDENTIAL
SITE:
AREA(S) AUDITED:
AUDIT TEAM: John
E. Lincoln
DATE(S) OF AUDIT:
DATE OF REPORT:
PERSON(S)
CONTACTED:
01. INTRODUCTION: [Background,
scope, team, process, timing, approach …]
03. MAJOR FINDINGS
AND OBSERVATIONS:
[Completed Matrix findings and expamded discussions
of findings]
04. RECOMMENDATIONS:
Signed:
Printed
Name: John E. Lincoln
Date:
-- END OF
AUDIT REPORT BODY –
Attachments: 1 – ISO 13485:2016, Filled-In
Audit Matrix
2 – Current Company SOP Listing.
3 – Audit Plan
4 – Audit Flow Chart
-- jel@jelincoln.com
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