Internal Auditor Training for ISO 13485 (RABQSA Certified)

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Who Should Attend
Professionals who will conduct, manage, or participate in internal (first-party) audits in the medical device industry. It is useful for those seeking to develop an ISO 13485-compliant quality management system.

Learning Outcomes

• Become familiar with the elements of a sound quality system.
• Understand the audit evidence necessary to comply with ISO 13485 requirements.
• Using ISO 19011 as a guide, learn preaudit activities, conducting the audit, and post-audit and follow-up activities.
• Know how to prepare for an audit and effectively manage your resources.
• Know how to collect audit evidence and document observations, including techniques for effective questioning and listening.
• Understand how to verify effectiveness of corrective action, close out an audit, and conduct follow-up surveillances.

Related ASQ Bodies of Knowledge
Certified Quality Auditor

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