ISO 13485:2016 Medical Devices Internal Auditor Training Course

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.