Internal Audit Report Template for ISO 13485
A practical internal audit reporting template for ISO 13485, with guidance on structure, findings and follow-up actions.
An effective internal audit report is more than just a tick in the box. It's a valuable tool that offers insights into your organisation's processes, pinpoints areas for improvement, and fuels continuous growth. But what should a well-structured audit report include?
ISO standards, including ISO 9001 for Quality Management Systems, require organizations to keep records of audits. This means your internal auditors need to produce thorough reports detailing what they covered, what they found, and who they audited.
To help your auditors create comprehensive reports, here's a breakdown of what a robust internal audit report should contain:
Executive Summary
This concise overview gives a snapshot of the audit's purpose, scope, timeframe, and key findings. It helps leadership quickly grasp the report's main points and potential areas of concern.
Audit Objective: Clearly state the purpose of the audit, e.g., to assess the effectiveness of the company's corrective action process.
Scope of the Audit: Outline the specific processes, departments, or activities covered in the audit.
Audit Dates: Specify the timeframe during which the audit was conducted.
Key Findings: Summarize the most significant observations from the audit, including any non-conformances identified.
Audit Details
This section delves into the nitty-gritty of the audit itself. It provides a clear picture of the methodology used and the sampling strategies employed.
Audit Methodology: Describe the approach used to conduct the audit, e.g., interviews, document review, observation of processes.
Sampling Methodology: Explain how the auditors selected data or activities for review. This ensures that the findings are representative of the overall process being audited.
Findings and Observations
This core section is the heart of the report. It details the specific observations made during the audit, categorized according to the relevant clauses of the ISO standard being audited or your own internal procedures. Be clear and concise, using factual evidence to support your observations.
Clause: Identify the specific clause or requirement from the ISO standard or internal procedure that was evaluated.
Finding: Describe what the audit uncovered, including any instances of non-conformance or areas where practices deviate from established procedures.
Evidence: Provide supporting documentation, interview notes, or observations that substantiate your findings.
Conclusions and Recommendations
Based on the findings, draw clear conclusions about the effectiveness of the processes or systems reviewed. Go beyond simply stating non-conformances. Analyse the impact of any identified issues and recommend specific actions to address them.
Conclusions: Summarise your overall assessment of the audited processes or system.
Recommendations: Clearly outline specific actions for improvement, assigning responsibility and timelines for implementation. Consider the root cause of any non-conformances and aim for corrective actions that prevent recurrence.
For an in-depth template to jumpstart your internal audit reporting, download our free template.
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