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.
Who should attend?
- 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.
What will you learn?
- 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
What do you need to prepare?
- 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
Your future development
- Tutored Audits (coached live audit at your company)
- See our Business Improvement courses.