ISO 13485 – Lead Auditor Training Course

Course Overview

This internationally recognized Lead Auditor Training Course prepares participants to plan, lead, manage, and report third-party certification audits of a ISO 13485 Medical Device Quality Management. The course is designed to develop competent Lead Auditors in accordance with ISO 19011 and covers the full audit lifecycle from programme management through to closing meetings and audit reports.

Learning Objectives

• Plan, lead, and manage a full ISO 13485 certification audit
• Manage audit teams and assign audit tasks
• Apply risk-based thinking to audit planning and execution
• Evaluate the effectiveness of a MD-QMS
• Prepare and present comprehensive audit reports
• Manage audit programme activities in accordance with ISO 19011

Topics Covered

• ›Advanced ISO 13485 requirements
• ›ISO 19011 – Auditing Management Systems
• ›Audit programme management
• ›Risk-based audit planning
• ›Audit team management
• ›Conducting stage 1 and stage 2 audits
• ›Audit evidence and sampling techniques
• ›Managing difficult audit situations
• ›Audit findings classification and documentation
• ›Writing professional audit reports
• ›Closing meetings and communication
• ›Post-audit follow-up and surveillance audits

Who Should Attend

• Third-party auditors and certification body personnel
• Consultants conducting supplier or customer audits
• Senior quality, environmental, or safety professionals
• Professionals seeking lead auditor qualification for career advancement

Learning Outcomes

• Lead certification and surveillance audits of any complexity
• Manage audit teams and audit programme activities
• Produce professional audit reports and findings
• Apply for professional Lead Auditor registration/certification