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?
- 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
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
- Consultants
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
What's included?
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
Contact us
If you have any enquiries, let us know how can we help you.
Call: +91 80815 80815
Email us: info.in@bsigroup.com
Notes:
- This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor. This will provide the delegate with the flexibility of attending it from the convenience of home or office, without travelling to BSI facility. A stable internet connection, headset with USB connection, a quiet and suitable work area. In advance of the training a ‘testing room’ will be provided for delegates to confirm their hardware works and that they can fully participate in the training.
- Examination will be conducted online via an e-assessment platform 'Questionmark'. Invigilation will be done through delegate’s webcam and microphone.
Please Note: This training fee is applicable only for residents of India and the Indian subcontinent.
