ISO 13485 Lead Auditor Practitioner Qualification

Level Practitioner Duration 7 days

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This first step on your auditor qualification journey is designed for senior management, regulatory affairs or quality managers, internal and external auditors with a need to understand the full requirements of the ISO 13485:2016 Quality Management System (QMS) standard. You’ll learn everything you need to become a Lead Auditor Practitioner, including how to manage an audit programme, how to apply risk-based thinking, and how to show leadership.

Expert BSI trainers will guide you on your learning journey and show you how to identify the aims and benefits of an ISO 13485:2016 QMS audit. You’ll also learn how to monitor supply chains to achieve continuous improvement, and how to develop safe and effective medical devices.

How will you benefit?

Full understanding of ISO 13485:2016 requirements
Able to explain and interpret requirements, relevant to your organization
Learn how a quality management system provides a framework for safer medical devices
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

Which qualification will I achieve?

On successful completion of your qualification, you’ll receive a BSI Mark of Trust that can be shared within your organization and across your network of contacts.

ISO 13485 Lead Auditor Practitioner qualification includes:

ISO 13485:2016 Clause by Clause (2 Days classroom – in-person or virtual)
- Full understanding of ISO 13485:2016 requirements
- Able to explain and interpret requirements, relevant to your organization
- Learn how a quality management system provides a framework for safer medical devices
ISO 13485:2016 Lead Auditor (5 Days classroom – in-person or virtual)
- 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 in planning, conducting, reporting and following up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate)
Each module is followed by a mandatory online examination. Delegates must pass the examinations to be awarded the qualification.
- Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management representatives
- Quality directors, managers, and engineers
- Consultants

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