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Audit Program

Use this Audit Program template to plan, schedule, and document your organization's internal audit activities, ensuring comprehensive coverage of your quality management system and compliance with regulatory requirements. Fill out this template before starting your audit cycle and update it after each audit to track completed processes and maintain readiness for inspections or certification audits. This tool is essential for demonstrating ongoing internal audit effectiveness and supporting regulatory compliance under ISO 13485, EU MDR, and FDA QSR.
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Audit Program

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1. Scope

This document provides an overview of the planned audit schedule for the organization according to SOP Internal Audit (Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.). The goal of the audit program is to ensure the quality management system conforms to planned and documented arrangements, quality management system requirements established by the organization, applicable regulatory requirements, and is effectively implemented and maintained. The audit program is a plan and may change due to capacity and breadth of internal audits that occur over time.

It is recommended that all sections of the quality management system are reviewed at least once within the course of 3 years, as needed. Priority shall be given to critical processes based on the types of medical products.

2. Audit Program Plan

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3 Audit Results

Audits will be planned and performed according to the SOP Internal Audit and will have their results recorded in the quality management system. Upon completion of an audit, this program will be updated with the processes that were reviewed during the audit.

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