(University at Buffalo: Buffalo, NY) -- The ISO 13485 internal auditor training program from the University at Buffalo provides the skills necessary to perform process audits in the medical device industry, which results in findings for continual improvement. Participants learn audit activities and techniques, what objective evidence to gather, and what third-party external auditors expect when determining ISO 13485 compliance.

Training focuses on process performance and compliance. The structure involves formal tutorials, group workshops, and open forum discussions.

Upon course completion, participants:
• Are able to complete an audit of their organization’s quality manual against the requirements of the standard
• Develop an understanding of the concepts and vocabulary of quality systems, their benefits, and approaches to effective management of quality systems
• Acquire a range of skills that will serve them well as an internal auditor, including audit diplomacy and communication skills, team-building skills, process assessment, and continual improvement

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