Requirements of ISO 13485:2016 PPT

Complete PowerPoint Training Package

$149.00

Use these materials to educate groups on the ISO 13485 standard.

  • Tailor it to fit your audience:
    • Present to Management Team as you investigate ISO 13485
    • Educate employees as your company implements ISO 13485 certification
    • Present to customers & vendors so they understand the requirements
  • Use the quizzes to ensure they comprehend the information
  • Provide a Certificate as a record of the ISO 13485 training

The training meets Sec. 6.2.2 requirement of the ISO 13485 standard:

  1. Employee Awareness – explains the Quality Management System
  2. Record of Training – The student will receive a certificate upon completion
  3. Training Effectiveness – It includes quizzes to ensure the student comprehends the information before moving onto the next section.
  • Includes Technical Support
  • The 77 slide PowerPoint includes detailed speaker’s notes covering:
    • What is ISO 13485?
    • Steps to registration
    • The process model/process approach
    • What are the requirements?
        • Section 4 – General Requirements
        • Section 5 – Management Responsibility
        • Section 6 – Resource Management
        • Section 7 – Product Realization
        • Section 8 – Measurement, Analysis & Improvement
    • What are the next steps for ISO 13485 certification?
  • 103 Page Trainer’s Guide(PDF)
    • Outline of speaker notes
    • Answer key for the quizzes
  • 37 page Student Guide
    • Copy of the slides and space for notes
    • Quizzes
  • Quizzes on the requirements
    • 2 Quizzes on the requirements
    • 66 questions in total
  • Customizable Certificate
    • Space for Student and Instructor’s names

Product Details

Product Type: Digital

Price: $149.00