ISO 13485 Audit Checklist for Compliance Assessment

This document is an ISO 13485 audit checklist designed to assist organizations in assessing their compliance with the ISO 13485 standard. It serves as a practical guide for various applications, including internal audit training, department-specific self-assessments, and spot-checks of areas that may be under-audited, such as regulatory or clinical affairs. The checklist encourages users to tailor it according to the specific scope of each internal audit, focusing on one area at a time, such as the CAPA and complaint system or production processes. It outlines the necessary steps for utilizing the checklist effectively, including reviewing each tab organized by ISO clause, clarifying terminology, and documenting compliance status. Additionally, it provides comparisons between ISO 13485 and ISO 9001 standards, aiding in understanding compliance expectations. The document emphasizes the importance of maintaining up-to-date procedures and records, ensuring that all quality management system processes are documented and compliant with regulatory requirements.