Course description
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.
Upcoming start dates
Suitability - Who should attend?
- Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management representatives
- Quality directors, managers, and engineers
- Consultants
Outcome / Qualification etc.
- In-depth understanding of how the ISO 13485:2016 interacts with the ISO 9001:2015
- Discover ways to increase efficiency and cost savings via quality management
- Learn how to build stakeholder confidence by understanding the up-to-date requirements
- Gain formal recognition of your knowledge and learn how to directly apply your skills in your organization
- Contribute to your career progression and unlock access to a wider range of higher-level and more advanced specialized qualifications
- Engage with a global community of fellow qualified professionals to share experiences and practical advice to use in your everydays life
Training Course Content
ISO 13485 Lead Auditor Practitioner qualification includes:
ISO 13485:2016 Requirements
- Gain an appreciation for the origins of ISO13485
- Understand the use of ISO13485 as the basis for a Quality Management System for Medical Device organisations
- Gain awareness of the key differences to the ISO9001:2015 standard
- Understand the process approach concept of the standard and the Plan-Do-Check-Act (PDCA) framework
- Learn the overall structure of ISO 13485:2016
- Recognize the key clauses of the ISO 13485:2016 standard
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 multiple-choice examination. Delegates must pass the examination to be awarded the qualification.
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BSI, the British Standards Institution, is one of the world’s leading providers of training, certification, standards, regulatory approval, business improvement and management development for local and global audiences.
Our expert teams provide top quality training to organizations of all sizes and every type of industry - ranging from leading multinationals to small, innovative start-ups and from governments to charities. From understanding how a standard can help your business,...