Online ISO 13485 version 2016 Medical Devices Quality Management System Internal Audit course

The menu of the course

• Presentation
• MCT (multiple-choice test) Beginning (10 questions)
• 1 Scope
• 2 Normative references
• 3 Definitions
• 4 Principles
  • 4.1 Management principles
  • 4.2 Audit principles
  • 4.3 QMS performance
• MCT Internal audit (6 questions)
• 5 Audit programme
  • 5.1 General
  • 5.2 Objectives
  • 5.3 Establishing
  • 5.4 Implementing
  • 5.5 Monitoring
  • 5.6 Reviewing and improving
• Case Audit programme
• MCT Audit programme (11 questions)
• 6a Audit preparation
  • 6.1 General
  • 6.2 Initiating
    • 6.2.1 First contact
    • 6.2.2 Situations and feasibility
  • 6.3 Preparing the audit
    • 6.3.1 Document review
    • 6.3.2 Audit plan
• Case Audit readiness
• MCT Audit preparation (9 questions)
• 6b Performing an audit
  • 6.4 Audit activities
    • 6.4.1 Opening meeting
    • 6.4.2 Audit evidence
    • 6.4.3 Audit conclusions
  • 6.5 Audit report
  • 6.6 Completing the audit
  • 6.7 Audit follow-up
• Case Audit report
• Case Management review
• MCT Performing an audit (8 questions)
• 7 Competence and evaluation of auditors
  • 7.1 General
  • 7.2 Auditor competence
  • 7.3 Evaluation criteria
  • 7.4 Evaluation methods
  • 7.5 Auditor evaluation
  • 7.6 Improving the competence
• Case Auditor question
• MCT Auditor competences (8 questions)
• MCT End (20 questions)