This two-day course will improve the effectiveness of the Quality Management System and help you understand the best practices to conduct an effective internal audit in accordance with the requirements of ISO 13485:2016.
Who should attend?
Individuals needing to conduct an effective QMS audit in accordance with the requirements of ISO 13485:2016 and ISO 91011:2011
What will you learn?
- An overview of the ISO 13485 requirements
- The management systems and internal audits roles
- The roles and responsibilities of an Internal Auditor
- Plan your audits and how to develop the effective checklists
- How to carry out effective audits using LR's 6 Stage Approach
- To gather objective evidence through observation, interviewing and sampling of documents
- To evaluate audit findings and determine conformity, nonconformity and effectiveness
- To report findings accurately, adding value to the business
- What is corrective action and who is responsible for implementation
- How to follow up and verify the effectiveness of corrective action taken
- How to address common internal audit weaknesses within the medical device industry.
What do you need to prepare?
To have successfully completed Introduction to ISO 13485 course.
- Training course materials
- Lunch and refreshments for public attendees only
- Certificate of attendance.
Training from LR
With Lloyd's Register, you can learn in the way that works for you. We offer courses in a range of styles, from in-house to virtual classroom. Find out more about Ascend Training Courses from Lloyd's Register.
Your future development
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.
If you are looking for a course for four or more people, you may find our in-house option more cost-effective. Contact the team for a quote.