ISO 13485 Internal Audit Checklist Free Download

Preparing for an ISO or FDA inspection means making sure that your quality management system (QMS) is in tiptop shape; having access to the right tools can assist in that endeavor.

One vital tool in auditing is an audit checklist. An audit checklist lists questions an auditor should pose and activities they should observe to ensure compliance with standards.

How to Use the Checklist
The ISO 13485 audit checklist is an easy-to-use tool that helps auditors assess their own quality management systems. Available for free download, this tool ensures all required elements of medical device manufacturing are taken into account during production. Any organization manufacturing, distributing or servicing medical devices must pass an intensive ISO 13485 audit. Internal auditors may use it internally while external auditing organizations use it during a Stage 1 or 2 audit to check processes internally or independently.

Audit checklists typically cover internal activities, supplier evaluation and documentation and records as well as recommendations, notes and signatures. It is best if they are filled out by those overseeing auditing, so any issues identified can be dealt with quickly. Using digital QMS systems for tracking all internal processes can help your company meet ISO 13485 standards more easily – aiding certification efforts as well.

Requirements of the Checklist
The checklist features an intuitive design to aid organizations in their preparation for third-party audits. It includes fields for observations and comments as well as spaces to record results and take internal corrective actions if applicable.

Clause 8 of ISO 13485 also stipulates a company should create and implement an effective quality feedback loop, including processes for handling complaints, field failures and product recalls. This requirement demonstrates the company has processes in place to respond swiftly to quality issues while prioritizing customer safety.

The checklist requires an auditor to ensure that each process audited has documented procedures, work instructions, and training records that meet ISO 13485 standards and an ongoing corrective/preventive action plan is in place – as this step ensures the company meets ISO 13485 requirements and is prepared for a third-party audit.

Format of the Checklist
As part of creating their checklist, auditors should ensure it covers all requirements set forth by their standard. A process/clause matrix can help identify all clauses which need to be covered for an effective audit of a process.

This will include reviewing the process to ensure all necessary steps are being taken to guarantee quality, as well as reviewing records associated with that process as stipulated by standard. Finally, this evaluation should also cover corrective and preventative actions (CAPAs), to make sure they are being handled according to requirements set by standard.

As such, an auditor will be able to assess whether or not your process meets all of the ISO 13485 standard’s requirements and make any necessary recommendations so that your company is compliant.

Downloading the Checklist
If you want to quickly assess whether your organization’s Quality Management System (QMS) adheres to ISO 13485 standards and evaluate readiness for third-party audit, using a checklist can be an excellent way. With its series of questions and status updates that ensure all planned activities, such as supplier evaluation and reviewing supplier audit reports are taking place as planned, this tool provides a quick way to do both tasks.

Verifying that production and service controls are in place to guarantee the quality of medical devices is also on the checklist, including providing proper training to personnel, keeping equipment calibrated, following procedures as outlined, checking records for nonconformances, complaints, or corrective actions to make sure these were handled appropriately, etc.

Qualio offers a cloud-based tool designed to assist your team with internal audit processes. It streamlines this entire process and keeps your team compliant year-round – request a demo now to find out more!