Auditor/Lead Auditor Training for ISO 13485

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Who Should Attend
Professional involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier QA effort.

Learning Outcomes

• Understand the elements that constitute a quality system
• Know the ISO 13485 standard requirements
• Understand the audit evidence necessary to comply with ISO 13485 requirements
• Using ISO 19011, understand preaudit, auditing, and post-audit follow-up activities
• Know how to plan audit activities, develop checklists, and perform preassessment visits
• Learn how to conduct opening and closing meetings tailored to the medical device industry
• Understand how to collect audit evidence, handle confrontations, and improve listening and questioning techniques

Related ASQ Bodies of Knowledge
Certified Quality Auditor

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