Designed by your partner in learning as an intensive course for medical device quality professionals, this ISO 13485 internal auditor training builds knowledge for an effective quality management system.
The two-day training is delivered either in person or live online in a classroom environment. Guided by experienced instructors, you will learn how to explain the structure and scope of the standard and identify an auditor’s key responsibilities. You’ll also discuss every stage of the internal audit process through role-play, workshops and tutorials, plan and conduct an audit and assess if it was done effectively.
Although some prior understanding of ISO 13485:2016 is useful, you’ll leave the course with all the knowledge you need. You’ll be able to maintain compliance and internal processes and motivate colleagues to do the same.
How will I benefit?
- Able to fully grasp and comply with ISO 13485:2016
- Confidence that your organization is using competent auditors
- Maintain rigorous internal processes
- Write factual audit reports and suggest corrective actions
Who should attend?
- Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
- Individuals interested in conducting first-party or second-party audits
- Management representatives
- Internal auditors
- Managers
- Consultants
What will I learn?
- Explain the structure and scope of the ISO 13485:2016 management system standard and how it applies to the organization aiming for regulatory compliance worldwide
- Identify the principles of auditing and auditor responsibilities
- Plan an internal audit
- Conduct informal opening and closing meetings
- Conduct an audit based on process identification sampling and questioning
- Provide verbal and written feedback
- Document coincide non-conformities
- Effectively report on an audit
- Follow-up on corrective actions
What is included?
- A loan copy of the standard for use during the course
- Gain an internationally recognized BSI Training Academy certificate
- Gain 16 CPD points on completion and comprehensive training notes
Prior knowledge and learning
You should have experience with, or basic knowledge of, quality management systems for the medical device industry. We recommend you have a basic awareness of medical device development, quality assurance and ISO 13485:2016. The requirements of ISO 13485 course are not taught on this course. For those who don’t have the above, you will first need to attend our ISO 13485 Clause by Clause.
Assessment
On completion of the ISO 13485 Internal Auditor course participants will have the option to complete an online multiple choice exam. If you choose not to sit the exam, a certificate of attendance will be issue for the course.
