ISO 13485 Internal Auditor Course

ISO 13485 is an international standard that outlines the requirements for a quality management system in the medical device industry. This internal auditor training course for ISO 13485 can help individuals gain the skills and knowledge necessary to assess the effectiveness of their organization’s quality management system and identify areas for improvement.

An ISO 13485 internal auditor is an individual who has the knowledge and skills to assess the effectiveness of a medical device quality management system (QMS) against the requirements of the ISO 13485 standard. The role of an internal auditor is to provide independent and objective evaluations of the QMS, identify areas of non-conformance or opportunities for improvement, and report findings to management for corrective action.

This training courses covers the following topics:

• The requirements of the ISO 13485 standard and how to interpret them
• The role and responsibilities of an internal auditor
• The process for planning, conducting, and reporting on an internal audit
• Techniques for interviewing, observation, and document review during an audit
• Non-conformity identification and correction
• Audit follow-up and evaluation of corrective actions

Once certified, ISO 13485 internal auditors may be responsible for conducting audits of their organization’s QMS or supporting audits conducted by external auditors. They play an important role in ensuring that the organization’s QMS is effective, compliant with regulatory requirements, and continuously improving.