This intensive two day course is intended for medical device quality professionals aiming to build on their knowledge of ISO 13485:2016 and evaluate the effectiveness of the quality management system in their organization.
Learn the principles and practices of effective quality management systems process audits in accordance with the ISO 13485:2016 and ISO 19011:2018.
An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, and group workshops.
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 16 CPD points on completion and comprehensive training notes
- Gain an internationally recognized BSI Training Academy certificate
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.
