External Audit Finding Log
Audit template
External Audit Finding Log for medical device internal and supplier audits
Use this editable External Audit Finding Log to plan, execute and close audits with clear findings, conclusions and corrective actions.
- Best for: internal audits, supplier audits, MDR/ISO 13485 audit programmes and audit reporting.
- Includes: editable sections for audit programme, plan, report, findings and conclusion.
- Format: editable template available through the standard WooCommerce download flow.
Lexqara prepares manufacturers and suppliers for medical device audits with practical tools and hands-on support. Explore the Resource Center or review our Quality Management System Audit Services.
Description:
This log captures and tracks external audit findings from identification through closure so we can maintain an auditable trail of decisions, actions, and objective evidence.
- Assign a unique Finding ID and record Audit date and auditor/source for traceability
- Document the finding Description and map it to the applicable Requirement/Clause
- Classify severity using Grading (major/minor) and record Risk/impact notes where relevant
- Define Correction and the linked CAPA reference (or document why CAPA is not required)
- Set Owner and Due date to control accountability and timely follow-up
- Track Status (open/in progress/closed) with key milestones and completion dates
- Capture Closure evidence and an Effectiveness check outcome before final closure
This external audit finding log is used immediately after an external audit to centralize findings, drive consistent responses, and maintain revision-safe traceability from nonconformity to closure.
At Lexqara, we help you operationalize audit response workflows, strengthen CAPA traceability, and embed the log into QMS routines (audits support, training, and inspection readiness). Use our Resource Center [https://lexqara.com/resource-center] and Audits & Training [https://lexqara.com/services/audits-training], and align expectations with the European Commission medical devices sector overview [https://health.ec.europa.eu/medical-devices-sector_en]. Download the template and request a short gap assessment.
Free