Overview:

The ISO 13485:2016 Auditor qualification focuses on auditing Quality Management Systems (QMS) for organizations involved in the design, production, installation, and servicing of medical devices. This standard aligns with regulatory requirements and ensures that medical devices consistently meet customer and legal expectations for safety and performance.

Purpose:

To develop the knowledge and auditing skills required to:

• Evaluate an organization’s QMS compliance with ISO 13485:2016

• Identify risks, nonconformities, and opportunities for improvement

• Conduct effective internal, supplier, or external audits in the medical device sector

• Contribute to regulatory compliance and quality assurance

Key Learning Outcomes:

Participants will learn to:

• Understand the structure and requirements of ISO 13485:2016

• Interpret key clauses related to medical device quality management

• Plan, conduct, and report audits based on ISO 19011 auditing principles

• Identify areas of risk within QMS processes

• Support continual improvement of the organization’s quality system