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ISO 13485 Employee Training Details

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The course is approximately 30 minutes, includes audio, quizzes, and is intended for ALL of
the employees in an organization so they understand the importance of
ISO 13485.
There are 4 sections covering various aspects of ISO
13485:
- What is ISO?
Introduction to ISO 13485
Why is it important
Section 4 - General Requirements
Quiz
- Resource Management
Section 5 - Management Responsibility
Section 6 - Resource Management
Quiz
- Product Realization
Section 7 - Product Realization
Quiz
- Measurement and Analysis
Section 8 - Measurement, Analysis and Improvement
Quiz
| ISO 13485 has training requirements - we meet them! |
Section 6.2.2 of the ISO 13485 standard requires that you retain a record of the training and
prove its effectiveness. Learn about ISO 13485 Training Requirements...
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The student must pass a final quiz to make sure they understood
the material. If they fail a section, they must re-take that section
until they pass.
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It then creates a record by printing a certificate with the students'
name on it.
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Custom training can automatically send
results to a file, email address or Learning
Management System (LMS) if SCORM
Compliant.
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