Templates
ISO 13485 internal audit checklist template

ISO 13485 internal audit checklist template

Ensure medical device quality with a checklist tailored to ISO 13485 standards. Identify compliance gaps, enhance quality management systems, and ensure product safety.

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The Lumiform application helps frontline teams uphold internal standards effortlessly.
  • Customize this template or build your own
  • Fill out templates via mobile app
  • Assign and track corrective actions
  • Get reports and analyse your data
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ISO 13485 internal audit checklist template

Ensure medical device quality with a checklist tailored to ISO 13485 standards. Identify compliance gaps, enhance quality management systems, and ensure product safety.

Use this template with Lumiform

The Lumiform application helps frontline teams uphold internal standards effortlessly.
  • Customize this template or build your own
  • Fill out templates via mobile app
  • Assign and track corrective actions
  • Get reports and analyse your data
Prices start from ░░░ per month
Book a demo
Learn more
or Download template as PDF

This ISO 13485 internal audit checklist is a practical tool for assessing conformity with the standard for quality managers and compliance teams in the medical device industry. You can verify that your quality management system (QMS) meets strict regulatory requirements, reducing the risk of nonconformities and recalls. With more than 33,000 organizations worldwide certified to ISO 13485, the need for robust internal audit processes is clear and growing.

Unlike generic audit checklists, this template addresses the unique documentation, traceability, and risk management demands of ISO 13485. It’s focused on device-specific processes such as design controls and validation. If you need to audit broader management systems, consider our ISO 9001 or internal quality audit checklists.

Related categories

Preview of the template
Regulatory Requirements
Is the quality management system established, documented, implemented and maintained in accordance with ISO 13485 requirements?
Are all applicable regulatory requirements identified and addressed within the quality management system?
Product Safety
Are procedures in place to ensure that medical devices are designed and developed to meet safety and performance requirements?
Are procedures established to identify, document and investigate incidents and nonconformities related to the safety of the medical device?
Process Validation
Are processes validated where the resulting output cannot be fully verified by subsequent monitoring or measurement?
Are procedures established to ensure that equipment used in the manufacturing process is appropriate for its intended use?

Frequently asked questions

Which areas are most commonly found non-compliant during ISO 13485 internal audits?

Common non-compliance areas include incomplete documentation, insufficient risk management, lack of design control evidence, and inadequate supplier oversight. By focusing on these areas during your audit, you can better prevent major findings during external inspections.

What documentation is required for an iso 13485 internal audit?

You’ll need documented procedures for conducting audits, audit plans, checklists, records of findings, corrective action reports, and evidence of follow-up. Keeping these documents well-organized is crucial for demonstrating compliance and continuous improvement.

What is ISO 13485?

ISO 13485 is an international standard that outlines the requirements for a quality management system (QMS) specifically for the medical devices industry. It helps organizations demonstrate their ability to provide medical devices and related services that consistently meet customer and regulatory requirements throughout the product lifecycle.

Who reviews the results of an ISO 13485 internal audit?

Audit results are typically reviewed by top management. ISO 13485 requires management to evaluate findings, ensure corrective actions are taken, and assess the effectiveness of the QMS as part of their ongoing responsibility.

This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.