ISO 13485:2016 Auditor/Lead Auditor – CQI & IRCA Certified.

This four day course is designed to provide a detailed understanding of the role and responsibilities of an Auditor/Lead Auditor, covering topics including audit processes and planning, gathering objective evidence and evaluation of audit findings.

• Auditors or Quality System Managers who need to audit against ISO 13485 requirements
• Individuals within the medical devices sector who wish to add credibility with a widely accepted qualification.

• Purpose of a QMS based on ISO 13485 and the ISO 9000 principles of quality management
• Essential definitions and terminology
• To analyse ISO 13485 clauses and suggest examples of evidence that would show conformance with these requirements
• Roles and responsibilities of an auditor / lead auditor
• Plan and conduct an interview with top management and evaluate an organisation’s quality policy and objectives
• Prepare an on-site audit plan that establishes effective audit trails across processes and between members of an audit team
• To audit processes for conformance and effectiveness, including any specific quality objectives
• To prepare thoroughly for audit and produce process based checklists
• To gather objective evidence through observation, interviewing and reviewing documentation
• To evaluate objective evidence and correctly identify conformance and non-conformance with requirements
• To report findings accurately against requirements of ISO 13485, write and grade non-conformity reports and evaluate proposals for corrective action
• To relate your audit findings to the policy and objectives of the organisation and present your overall evaluation to top management

• Knowledge and understanding of ISO 13485 and experience of auditing
• Ideally to have attended our ISO 13485 Appreciation and Interpretation course
• Basic understanding of how organisations work and the role of top management
• Good knowledge of ISO 13485 and the quality management principles and concepts
• Complete approximately 3 hours of pre-course work prior to attending the course.

• Training course materials
• Lunch and refreshments for public attendees only

• Tutored Audits (coached live audit at your company)
• See our Business Improvement courses.

Four days.