ISO 13485 Fundamentals

ISO 13485 Fundamentals Series

Product: LP13485

Description: ISO 13485 Quality Management System training gives you an understanding of all the specific requirements in the standard, how to create a QMS, and the specific clauses in easy to understand terms for proper QMS implementation. The training series includes Internal Auditor training and certificate upon completion.

Length: 11 hours of online training

Contents:  31 Courses

Cost: $999 per seat or $1,999 up to 5 seats

In the ISO 13485 Fundamental Series you will learn:

 Getting Started on your Certification
 ISO 13485 Overview
 MS Planning for ISO 13485
 Risk-Based Thinking
 Process Planning
 Measurement Planning
 Document and Record Control
 Medical Device File
 Leadership Responsibilities
 Resource Planning
 Competency, Training, and Awareness

✔ Corrective Action
✔ Advisory Notices
✔ Design and Development
✔ Understanding Customer Product Requirements
✔ Calibration
✔ Purchasing
✔ Providing Products and Services
✔ Complete Internal Auditor Training and Certificate
✔ ISO 13485 Tour
✔ Preparing for your Registrar’s Audit

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