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:
- Employee Awareness – explains the Quality Management System
- Record of Training – The student will receive a certificate upon completion
- 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?
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- Section 4 – General Requirements
- Section 5 – Management Responsibility
- Section 6 – Resource Management
- Section 7 – Product Realization
- Section 8 – Measurement, Analysis & Improvement
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- 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
