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ISO 13485 2016 Course: Quality Management System for Medical Devices

Curriculum

  • 7 Sections
  • 13 Lessons
  • 6 Hours
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  • Module 1: Introduction to ISO 13485:2016
    2
    • 1.1
      Module 1 – Introduction to ISO 13485:2016
    • 1.2
      Quiz on Module 1 of ISO 13485:2016
      10 Questions
  • Module 2: Quality Management System (Clause 4)
    2
    • 2.1
      Quality Management System (ISO 13485:2016)
    • 2.2
      Quiz on Module 2 of ISO 13485:2016
      10 Questions
  • Module 3: Management Responsibility (Clause 5)
    2
    • 3.1
      ISO 13485:2016 Module 3 – Management Responsibility
    • 3.2
      Quiz on Module 3 of ISO 13485:2016
      10 Questions
  • Module 4: Resource Management (Clause 6)
    2
    • 4.1
      ISO 13485:2016 Module 4 – Resource Management
    • 4.2
      Quiz on Module 4 of ISO 13485:2016
      10 Questions
  • Module 5: Product Realization (Clause 7) – Overview
    10
    • 5.1
      ISO 13485:2016 Module 5.1 – Planning and Customer-Related Processes
    • 5.2
      Quiz on Module 5.1 of ISO 13485:2016
      10 Questions
    • 5.3
      ISO 13485:2016 Module 5.2 – Design and Development
    • 5.4
      Quiz on Module 5.2 of ISO 13485:2016
      10 Questions
    • 5.5
      ISO 13485:2016 Purchasing and Supplier Controls
    • 5.6
      Quiz on Module 5.3 of ISO 13485:2016
      10 Questions
    • 5.7
      ISO 13485:2016 Module 5.4 – Production and Service Provision
    • 5.8
      Quiz on Module 5.4 of ISO 13485:2016
      10 Questions
    • 5.9
      ISO 13485:2016 Monitoring and Measuring Equipment: Ensuring Compliance and Reliability
    • 5.10
      Quiz on Module 5.5 of ISO 13485:2016
      10 Questions
  • Module 6: Measurement, Analysis, and Improvement (Clause 8)
    6
    • 6.1
      ISO 13485:2016 Module 6.1 – Monitoring and Measurement
    • 6.2
      Quiz on Module 6.1 of ISO 13485:2016
      10 Questions
    • 6.3
      Control of Nonconforming Product in ISO 13485:2016
    • 6.4
      Quiz on Module 6.2 of ISO 13485:2016
      10 Questions
    • 6.5
      ISO 13485:2016 Module 6.3 – Data Analysis and Improvement
    • 6.6
      Quiz on Module 6.3 of ISO 13485:2016
      10 Questions
  • Module 7: Course Wrap-Up and Certification
    2
    • 7.1
      ISO 13485:2016 Certification Readiness & Course Wrap-Up
    • 7.2
      Quiz on Module 7 of ISO 13485:2016
      10 Questions
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ISO 13485:2016 Module 5.1 – Planning and Customer-Related Processes
ISO 13485:2016 Module 5.2 – Design and Development
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