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ISO 13485 supplier audit checklist template

ISO 13485 supplier audit checklist template

Guarantee compliance with medical device standards using our comprehensive and customizable ISO 13485 supplier audit checklist template. Conduct powerful quality audits and safety inspections to ensure your suppliers meet industry requirements. Download your free PDF now from Lumiform.

Use this template
or download pdf
ISO 13485 supplier audit checklist template

Guarantee compliance with medical device standards using our comprehensive and customizable ISO 13485 supplier audit checklist template. Conduct powerful quality audits and safety inspections to ensure your suppliers meet industry requirements. Download your free PDF now from Lumiform.

Use this template
or download pdf

About the ISO 13485 supplier audit checklist template

Ensuring compliance with ISO 13485 standards is crucial for maintaining a safe and efficient supplier management process. Our ISO 13485 supplier audit checklist template is designed to help you conduct thorough inspections, identify potential hazards, and ensure compliance with ISO 13485 regulations.

Using this template, you create a safer workplace and promote a culture of quality within your organization. Make your supplier management safer and more efficient with our easy-to-use checklist.

Enhance your company’s reputation for quality and ensure compliance with ISO 13485 regulations.

The primary purpose of our ISO 13485 supplier audit checklist template is to provide a structured and systematic approach to inspections that aligns with ISO 13485 regulations. This template helps you identify and address potential hazards before they escalate into serious issues, ensuring a safer work environment.

This checklist streamlines inspections, promotes quality culture, and reduces nonconformities in supplier management. It ensures compliance with ISO 13485 regulations, preventing fines and enhancing your company’s reputation. Ultimately, it fosters a proactive quality culture, boosting employee morale, productivity, and operational efficiency.

Key elements of the ISO 13485 supplier audit checklist template

Our ISO 13485 supplier audit checklist template includes several key elements to ensure comprehensive inspections. It covers critical areas such as:

  • Quality management system: Verify that the supplier has a documented quality management system and that it meets the requirements of ISO 13485. Check if the quality manual is available and current, the quality policy is defined and communicated, and quality objectives are established.
  • Management responsibility: Assess the commitment of top management to the quality management system. Check if management reviews are conducted periodically and if corrective and preventive actions are implemented effectively.
  • Control of documents and records: Ensure that procedures for document control and record control are established. Verify that documents and records are legible, identifiable, and stored securely. Confirm that document changes are reviewed and approved appropriately.
  • Resource management: Ensure that personnel are competent and trained, the infrastructure is suitable for operations, and the work environment is controlled to meet product requirements.
  • Product realization: Confirm that planning of product realization is established, customer requirements are determined and met, and design and development processes are planned and controlled. Verify that the purchasing process is controlled, production and service provision are carried out under controlled conditions, and nonconforming products are identified and controlled.
  • Measurement, analysis, and improvement: Ensure that internal audits are conducted, monitoring and measurement of processes and products are established, and analysis of data is performed to demonstrate the suitability and effectiveness of the QMS. Verify that improvement activities are implemented to enhance the quality management system.

Each section is designed to guide specific checks, aiding in effective risk identification and mitigation. This comprehensive approach ensures no aspect of supplier quality management is overlooked, maintaining a safe environment compliant with ISO 13485 regulations.

Get started with Lumiform’s ISO 13485 supplier audit checklist template

Ready to enhance safety in your supplier management process? Download Lumiform’s free ISO 13485 supplier audit checklist template today and start conducting thorough and effective inspections.

Our user-friendly template will help you ensure compliance, protect your employees, and maintain a safe and efficient supplier management environment. Begin the journey towards a safer workplace now! Download your free checklist and transform your supplier quality standards with Lumiform.

Click here to get started today!

Related categories

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Preview of the template
Page 1
General Information
Supplier Name
Audit Date
Auditor Name
Quality Management System
Supplier has a documented quality management system
Quality manual is available and current
Quality policy is defined and communicated
Quality objectives are established
Management reviews are conducted
Corrective and preventive actions are implemented
Control of Documents and Records
Procedure for document control is established
Procedure for record control is established
Documents and records are legible and identifiable
Document changes are reviewed and approved
Records are stored and protected
Resource Management
Personnel are competent and trained
Infrastructure is suitable for operations
Work environment is controlled
Product Realization
Planning of product realization is established
Customer requirements are determined and met
Design and development is planned and controlled
Purchasing process is controlled
Production and service provision is controlled
Verification, validation, monitoring, measurement, inspection and test activities are established
Nonconforming product is identified and controlled
Measurement, Analysis and Improvement
Internal audits are conducted
Monitoring and measurement of processes and product is established
Analysis of data is performed to demonstrate suitability and effectiveness of the QMS
Improvement activities are implemented

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Related resources

Access a complete set of resources aimed at maximizing safety, quality, and operational excellence, including detailed guides, related templates, and real-world use cases.

Topic guides

Read in-depth guides covering key topics related to this article.

Mastering supplier quality management: A comprehensive guideHow to assess supplier performance? An extensive guide on supplier evaluationSupplier selection process: A complete guide
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Template collections

See comprehensive collections of best practice templates related to this topic.

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Use cases

Check out how the Lumiform software can be utilized for related use cases.

Supplier quality management softwareSupplier evaluation softwareSupply chain management softwareSupplier audit software
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Other resources

Explore all the additional resources we offer to assist you in mastering this topic.

5 steps of the supplier selection process8 Key focus areas of a supplier audit formQuality management processHow to implement operational excellenceHow to evaluate compliance measuresHow to perform incoming goods inspections4 strategies for developing a quality management plan4 ways process improvement increases profits

Frequently asked questions

What is the purpose of my supplier quality audit checklist?

Utilizing an ISO 13485 supplier audit checklist template is crucial for ensuring suppliers adhere to medical device standards. It helps identify compliance gaps and quality issues early, safeguarding product integrity and patient safety. This proactive approach supports regulatory compliance and strengthens supplier relationships, minimizing risks.

What challenges might arise during an ISO 13485 supplier audit?

During ISO 13485 supplier audits, your team might encounter documentation inconsistencies, non-compliance with regulatory standards, or inadequate quality management systems. These challenges often arise from insufficient training or process oversight. Addressing them is vital to maintaining supplier performance and ensuring regulatory adherence.

How can my business efficiently schedule ISO 13485 supplier audits?

Efficiently scheduling ISO 13485 supplier audits requires a structured plan, considering supplier criticality and past performance. Use digital tools to track audit timelines, record findings, and schedule follow-ups. Engaging qualified auditors ensures thorough assessments, maintaining compliance and optimizing supplier management.

What actions should I take if non-compliance is found during an ISO 13485 supplier audit?

If non-compliance is identified during an ISO 13485 supplier audit, promptly assess the issue’s impact and implement corrective measures. Collaborate with suppliers to develop improvement plans and monitor progress. Educate your team on compliance requirements to prevent future occurrences, ensuring continuous supplier performance.


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.
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