Templates
ISO 13485 supplier audit checklist template

ISO 13485 supplier audit checklist template

Guarantee compliance with medical device standards using our customizable ISO 13485 supplier audit checklist template. Conduct powerful quality audits and safety inspections.

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
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Learn more
or Download template as PDF
ISO 13485 supplier audit checklist template

Guarantee compliance with medical device standards using our customizable ISO 13485 supplier audit checklist template. Conduct powerful quality audits and safety inspections.

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 supplier audit checklist helps medical device manufacturers thoroughly evaluate suppliers against quality management system requirements. It simplifies the supplier qualification process, ensuring you capture critical areas from document control to nonconforming product handling.

When a component supplier fails to meet quality standards, it can lead to costly product recalls and compliance issues. With over 33,000 ISO 13485 certificates issued globally, the checklist provides a structured approach to verify if your suppliers meet these widely adopted standards. This reduces risk so you can maintain consistent quality across your supply chain.

Related categories

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

Frequently asked questions

What should I focus on during an ISO 13485 supplier audit?

Focus on areas that directly impact your medical device quality and safety. Prioritize the supplier’s document control system, corrective action processes, and how they handle nonconforming products. Pay special attention to their design controls if they’re developing components specifically for your devices. The goal is verifying they can consistently meet your requirements.

How do I determine which suppliers need a full ISO 13485 audit?

Assess each supplier based on the risk their products pose to your finished device. Suppliers of custom-designed components, sterile materials, or items directly affecting safety and performance require comprehensive audits. For suppliers of standard catalog items with minimal impact on device safety, a simplified evaluation focused on delivery reliability may be sufficient.

What documentation should I request before conducting a supplier audit?

Request the supplier’s quality manual, relevant procedures, certifications (ISO 13485, ISO 9001), recent internal audit reports, and corrective action logs. Also ask for examples of their manufacturing records and process validation documentation for components similar to what they’ll provide to you. This pre-audit review helps focus your on-site time efficiently.

How can I use this checklist for remote supplier audits?

For remote audits, use this checklist in a digital format on Lumiform and request evidence for each requirement in advance. Schedule video conferences to observe critical processes and interview key personnel. Ask the supplier to share screens showing their quality system documentation and records. Follow up with specific questions based on your findings from the document review.

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.