Internal Audit Schedule Template - ISO 13485

ISO 13485:2016 QMS Template - Internal Audit Schedule (QMS.8.2.4.1 - QR)

Enhance your Quality Management System with our ISO 13485:2016 compliant Internal Audit Schedule template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

• Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.
• Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
• Compliance Assurance: Utilizing our template helps you maintain an effective internal audit schedule, demonstrating robust quality management as required by ISO 13485:2016.

What is an Audit?

An audit is an independent examination of your Quality Management System (QMS) to ensure it meets the requirements of ISO 13485. The assigned auditor will review your QMS documents, records, and procedures to check for compliance with the standard. Your organization must schedule regular assessments by both internal and external auditors.

How Will Having an Internal Audit Schedule Help My Organisation?

The Internal Audit Schedule template helps your organization:

• Organize Audits: Set a clear schedule for performing internal quality audits.
• Define Audit Areas: Identify the areas for monitoring and reference the relevant sections of the regulation you will assess your QMS against.
• Ensure Compliance: Regularly check that your QMS conforms to planned arrangements, ISO 13485 requirements, and any applicable regulatory requirements.

What Does the Standard Say About Internal Audits?

The ISO 13485 standard requires organizations to perform regular internal audits at planned intervals. These audits must ensure that the QMS:

• Conforms to Planned Arrangements: Aligns with documented plans and procedures.
• Meets ISO 13485 Requirements: Complies with the standard and any applicable regulatory requirements.
• Plans an Audit Program: Considers the associated risk and importance of the processes being audited, as well as the outcomes of previous audits.

This template helps your organization meet these requirements and maintain an effective internal audit schedule.

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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