Ease compliance with ISO 13485 by implementing an eQMS and using an audit checklist to aid in certification.

This ISO 13485 Audit Checklist contains a series of questions and status updates to ensure that everything matches the plans defined in the organization’s eQMS regarding internal activities, supplier evaluation, and an evaluation of the supplier audit reports.

Use each of the checklist’s tabs in chronological order to help ensure your eQMS is aligned with ISO 13485 Standards and determine readiness for a third-party audit. 

Please submit the form to download the checklist now.