Creating a Strong ISO 13485 Audit Checklist for Medical Device Manufacturers

Creating a Strong ISO 13485 Audit Checklist for Medical Device Manufacturers

For medical device manufacturers, complying with quality management standards is essential to ensure patient safety and meet regulatory requirements. The ISO 13485 standard provides a framework for a quality management system specifically for medical devices. To ensure the effectiveness of the system and maintain compliance, regular internal audits are necessary. Along those lines, we’ve put together an ISO 13485 audit checklist that will help quality managers and operations teams with conducting a comprehensive audit of their quality management system. 

1. Management

The first section of the ISO 13485 audit checklist should focus on the management of the quality management system. This includes reviewing the company's quality policy, management responsibility, and training programs. Ensure that the policy is well understood, adequately communicated, and aligned with regulatory requirements. The management team should also establish clear roles and responsibilities for quality management and provide appropriate training to employees.

2. Documentation and Records

The next section of your ISO 13485 audit checklist should focus on documentation and records. Check if all policies, procedures, and work instructions are documented and up to date. Verify that records are maintained as per regulatory requirements and are easily retrievable. Check if document control procedures are followed, and the system is adequately protecting sensitive information.

3. Production and Service Controls

Production and service controls are crucial to ensure that the medical devices manufactured or serviced meet customer requirements and regulatory requirements. You’ll want a section in your ISO 13485 audit checklist that confirms that the production floor is following proper control procedures. Verify if the necessary equipment, tools, and materials are available and calibrated. Review the monitoring system in place to identify any non-conforming products or services and the mechanism to correct or control them.

4. Risk Management

Risk management is a critical area to include in an ISO 13485 audit checklist. Look into whether the company's risk management process complies with ISO 14971. Verify if the process is adequately implemented, and the risk analysis is appropriately documented. Review the risk management plan and post-production monitoring of the device's safety and performance. 

5. Supplier Management

The final section of your ISO 13485 audit checklist should focus on supplier management. Verify if the company has a well-defined process to identify and select suppliers and maintain registers of approved suppliers. Review the contracts with suppliers and ensure that supplier requirements are consistent with regulatory requirements. Check the supplier’s quality control procedures, delivery performance and review past audit reports.

The ISO 13485 audit checklist identifies the key areas that medical device companies must address to ensure compliance with the regulation and maintain patient safety. The checklist can be used to conduct a comprehensive review of the quality management system and identify areas for improvement. The audit process should be viewed as an opportunity to strengthen the system's effectiveness and demonstrate the company's commitment to quality. By using this checklist and addressing non-conformities, companies can improve their quality system and continue to provide safe and effective medical devices to their customers.
To get started with the ISO 13485 certification process, request a quote from one of our experts, or to learn more contact us directly with any questions that you may have.

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