Understanding ISO 19011:2018 - Webinar Recording/Transcript

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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.

Auditing is a multi-disciplinary activity. Quality auditors may come from a variety of departments and have varied backgrounds. Job functions that would benefit from the presentation include but aren’t limited to:

  • C-Suite execs
  • Quality managers
  • Department managers
  • Process owners
  • Audit managers
  • Lead auditors
  • Internal auditors
  • Supplier quality auditors

Dan O’Leary, our go-to presenter on quality management, is President of Ombu Enterprises LLC, a consultancy offering training and execution in Operational Excellence focused on analytic skills and a systems approach to operations management. Mr. O’Leary has more than 30 years experience in quality, operations and program management in regulated industries including medical devices, clinical labs, aviation and defense. He is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.