Understanding ISO 19011:2018 - Webinar Recording/Transcript
Understanding ISO 19011:2018: The Path to Better Medical Device System Audits
The rules on device quality auditing are changing. There’s a new ISO 19011:2018 out with a new focus on risk management.
FDAnews has called on Dan O’Leary, our go-to guy for quality management, to guide you through the ins and outs. In this 90-minute presentation, he’ll touch on the essentials of ISO 19011:2018 including establishment, implementation, monitoring, evaluation and competence of auditors, and the audit process itself. Prepare to discover:
- The basics: Learning and applying the seven principles of auditing
- The updates: How ISO 19011:2018 differs from ISO 19011:2011
- The six major steps: Understanding the six major steps to conducting an audit
- … and how they apply: Establishing, implementing, monitoring, review and approval of your audit program
- Auditor competence: Understanding and evaluating
- Types of audit sampling: And when to apply them
- Audit findings: Determining and recording
- And much more
Bonus Material: Participants receive an audit program checklist, based on the new standard, to help ensure an efficient and effective implementation.
You must adopt best practices and understand the risk-based approach of ISO 19011:2018 for auditing success. Take 90 minutes to master what’s new with the master of device quality management.