This IRCA registered five 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 analyze 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 organization’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 organization and present your overall evaluation to top management
- The certification requirements to become a registered auditor/lead auditor with IRCA.
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 organizations 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
Training from LR
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Certification with Exemplar Global
For an additional $99 USD you can also obtain an Exemplar Global Course Certification for your course.
What are the advantages of adding the Exemplar Global Certification?
With the additional Exemplar Global Course Certification, you will get access to:
- The Exemplar Global Work Style Behavioural Assessment
- One-Year Graduate Certification
- Use of Exemplar Global’s brands and logo to promote your certification
- Access to Exemplar Global Webinars and Online events
- Access to Exemplar Global online resources, including Auditor OnLine and regular Job Board notifications
- Access to the social community of graduates
- An innovative, continual learning environment for learners and graduates
- Ongoing support for an entrepreneurial career track for graduates and learners
How to add Exemplar Global Certification to your training course?
If you're booking online, you can add the option of Exemplar Global before you proceed to checkout or contact our team directly.