Medical Devices - QMS Auditor/Lead Auditor Training (ISO 13485:2016)

Level Lead auditor Duration 5 days

Available to book: Public classroom View dates and book now

From managing an audit programme to reporting on results, this lead auditor training course teaches you everything needed to conduct a quality management system (QMS) audit.

Led by experienced instructors over five days, the training is suited to quality managers, directors, engineers or consultants. It will help you fully identify the benefits of a QMS and explain the role of the auditor.

On completing this stage of your learning journey, you will be able to apply risk-based thinking, leadership and process management and understand the arrangements for BSI certification.

How will I benefit?

Identify the aims and benefits of an ISO 13485:2016 audit
Plan, conduct and follow up on auditing activities
Build stakeholder confidence by understanding the latest requirements
Gain 40 CPD points on completion of the course

On completion of this training, participants will be able to:
- Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011
- Identify the purpose and benefits of an ISO 13485:2016 QMS
- Explain the role of an auditor to plan, conduct, report and follow up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate).
- Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management representatives
- Quality directors, managers, and engineers
- Consultants
- 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.
- On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
Please Note: This training fee is applicable only for residents of India and the Indian subcontinent.
If you have any enquiries, let us know how can we help you.
Call: +91 80815 80815
Email us: info.in@bsigroup.com

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