ISO 13485:2016 Medical Devices Internal Auditor Training Course

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Description

This 3-Day course is designed primarily to provide participants with a detailed understanding of the changes and the effects of the new ISO 13485:2016 standard including risk management. In addition, upon successful completion of the course, participants will:

  • Be able to effectively plan, prepare and carry out an internal audit as per ISO 13485:2016
  • Be able to evaluate the significance of audit findings, develop and implement corrective action programs
  • Have the means to effect greater improvements on their quality systems

 

Course Content

  • Introduction to ISO 13485:2016
  • ISO 13485:2016 Overview
  • 1) Section 4: Quality Management System
  • 2) Section 5: Management Responsibilities
  • 3) Section 6: Resources Management
  • 4) Section 7: Product Realization
  • 5) Section 8: Measurement, Analysis and Improvement
  • Auditing ISO 13485:2016
  • Audit Performances and Audit Reporting
  • Corrective Action

Objectives

This 3-Day course is designed primarily to provide participants with a detailed understanding of the changes and the effects of the new ISO 13485:2016 standard including risk management. In addition, upon successful completion of the course, participants will:

  • Be able to effectively plan, prepare and carry out an internal audit as per ISO 13485:2016

  • Be able to evaluate the significance of audit findings, develop and implement corrective action programs

  • Have the means to effect greater improvements on their quality systems

Audience

  • Managers, Executives, Supervisors and those who are involved in organizing and conducting ISO 13485:2016 internal audits

  • Personnel who are involved in the implementation and maintenance of the quality management system in accordance to ISO 13485:2016 Standard, or those who wish to know more about the standard and its requirements.

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