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.
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
What will I learn?
On completion of this training, participants will be able to:
- Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance
- Identify the key principles of auditing and auditor responsibilities
- Plan an internal audit
- Conduct an effective audit based on process identification, sampling and questioning
- Determine if corrective action has been effectively implemented
How will I benefit?
- Maintain compliance with ISO 13485:2016
- Improve a global benchmark in quality standards
- Be confident that your organization can rely on competent auditors
- Motivate colleagues through CPD and ensure rigorous regulatory internal processes
- Write factual audit reports and suggest corrective actions
- You will gain 16 CPD points on completing the course
- This course does not detail the requirements of ISO 13485:2016 so some previous knowledge is required
- Training course notes
Additional course options
Discover our ISO 13485 Qualifications - Our ISO 13485 auditor qualifications will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner or Professional status by successfully completing courses, exams and demonstrating practical application. Find out more