Institute of Technology & Business Development

Institute of Technology & Business Development

Dates: October 26 and 27

Times: 8:30 am — 4:30 pm

Location: 185 Main Street, New Britain, CT 06051

Cost: $695

ISO 13485:2016 Internal Auditor

This course covers the fundamentals of auditing and specific techniques thereof. Included will be review and interpretation of the ISO 13485:2016 Standard as well as application of techniques during audit scenarios.
 
Content Outline:
 
• Audit Fundamentals
• Definitions, purpose, types
• ISO 13485:2016 requirements
• GMP background and FDA requirements
• What is auditing.
• Types of audits – 1st, 2nd & 3rd party audits?
• 3rd party auditing process and certification requirements
• Definitions of key words in ISO 13485 and GMP Standards
• Review of Standard requirements and summary of key points
• General requirements
• Changes from old Standard and newly emphasized points
• General review of 5 major categories
• Quality management system
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement
• Type of findings
• Minor non-compliances
• Major non-compliances
• Recommendations
• Corrective actions/follow-up
• Internal audit process