CSC-F-007-Internal-Audit-Report-Template.md

qms_version	2.2.0
sop_id	CSC PR.005
sop_version	2.0.3
template_id	CSC F.007
template_version	2.0.1

Internal Audit Plan and Report

General

Template ID	CSC F.007
Template Version	2.0.1
QMS Version	2.2.0
SOP ID	D PR.005 (QPulse)
SOP Version	1.3
Regulatory References	ISO 13485:2016 Section 8.2.4

Author
Approval

1. Audit Plan

Date	dd/mm/yyyy
Participants	Name and Role

1.1 Scope of the Audit

Enter the scope of the internal audit here

1.2 Audit Process

Audit Objective	e.g. Review of compliance of processes with regulatory requirements Review of compliance with processes Review of the effective implementation of corrective and preventive action (CAPA)
Inputs	e.g. Previous findings, CAPAs, QMS changes
Process records inspected	e.g. Named SOP's and example processes reviewed
Interviewed members of the CSC Team	e.g. Name / Role / Comments

2. Audit Findings

Date	dd/mm/yyyy
Audit Objective Reviewed	e.g. Review of compliance of the process of incident reporting
Outcome	e.g. Major Nonconformity / Minor Nonconformity

3. Auditor Report

Date	dd/mm/yyyy
Names Author(s)	Name and Role

Enter the details of the internal audit and recommendations if appropriate. Recommendations entail auditor advice for improved QMS effectiveness or efficacy

Template Copyright openregulatory.com. See template license.