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
Available delivery methods
Delivered by one of our expert trainers who facilitates participation and discussion.
Work with our training experts to develop a training course or programme specific to your exact requirements.