Audit Planning – Learn how to plan all aspects of an audit, including creating working documents.Process- and Risk-Based Approach to Auditing – Describe how to use a process- and risk-based approach to increase the value of your audits.Auditing Basics – Describe the audit cycle, auditor responsibilities, and identification of audit-related risks and opportunities.QMS Requirements – Describe the ISO 9000 standard series as well as analyze requirements of and relationship between ISO 9001:2015 and ISO 13485:2016.Quality Management System (QMS) Basics – Describe the core components of an effective QMS.Note: All attendees must study the current published version of ISO 13485 before attending class. In-person classes run as full-day sessions. Virtual seminars run as 1/2-day sessions.
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