ISO 13485:2016 Internal Auditor Live-Online (2-Day)
Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. Students participating in this course will gain knowledge and skills to implement a QMS with ISO13485:2016 management system requirements.
Many medical device companies are utilizing ISO 13485 as a platform to build their business management systems because of its value or because third-party certification is a specified requirement by customers and/or regulators.
Our training provides an overview, distributes knowledge, and arranges group exercises. You will be given group exercise case studies with examples from the aerospace industry will be used to help attendees gage where their QMS's has potential gaps and help meet their specific needs. Within the 2-Day Understanding and Documenting ISO 13485 for medical device training, you'll learn to:
- Understand the application of Quality Management Principles in the context of ISO 13485:2016.
- Interpret ISO 13485 requirements
- Plan and Execute the entire Audit process
- Understand Process and Auditing tools
- Conduct a successful Audit
- Terms and Definitions ISO 19011
- Understanding ISO 13485:2016 Clauses
This seminar is designed for:
- Management Representatives
- ISO 13485:2016 Implementation Teams
- Quality directors
- Engineers
- Auditors
- ISO coordinators
- Laboratory quality professionals
- Others who would like to learn the widely used international management systems auditing process.
Our training provides an overview, distributes knowledge, and arranges group exercises. This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.