ISO 13485:2016 Internal Auditor Training Course

Based on Medical Device Management Systems

Based on Medical Device Management Systems

WHAT YOU'LL GAIN BY ENROLLING FOR THIS iso 13485 internal auditor COURSE?

  • Globally accepted ISO 13485:2016 Internal Auditor certificate
  • Understand the requirements of ISO13485:2016 for medical products and related services
  • Acquire the skills to take on the position of an internal medical services auditor in the company, including how to plan, conduct and report an audit
  • Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
  • Deepen your knowledge through case studies and exercises

ABOUT ISO 13485 INTERNAL AUDITOR TRAINING COURSE

To keep quality management system standards relevant to the community of users, ISO 13485, the internationally recognized quality management system standard for medical devices industry, underwent major changes by the Standard Body and the revised medical standard ISO 13485:2016 was published on February 25, 2016.

This two-day training is to highlight the significant changes that affect registrants within the scheme, to help organisations understand some of the changes, how the changes may impact them, and how to audit against the revised ISO 13485 standard.

TRAINING DURATION

2 Days Instructor-led training

WHO SHOULD ATTEND?

This course is ideal for Quality and Regulatory Managers/Supervisors, Product Designers, Management Representatives and Consultants, Internal Auditors and Consultants. 

LEARNING AND CAREER BENEFITS

  • Understand the requirements of ISO 13485:2016, a standalone Quality Management Systems standard for Medical Device manufacturers that is mandatory while fulfilling the regulatory compliance
  • Learn to perform internal auditor activities and evaluate your organization’s Medical Device Quality Management System
  • Learn about the Guidelines of Medical Device Quality Management System auditing according to ISO 13485:2016

PRE-REQUISITES

Having prior knowledge and understanding of the Quality Management System - ISO 13485 Standards and/or experience in medical device operations.

EXAMINATION AND CERTIFICATION

Written examination will be conducted at the end of the course. Participants will receive a certificate upon completion of course.

For any any enquiries, please fill up the adjacent form.

CONTACT US TO KNOW MORE

Fill up the form on this page and we will be in touch with more details.

FIND OUT MORE