Quality Management System

ISO 13485:2016 Internal Auditor Training Course

Based on Medical Device Management Systems

Based on Medical Device Management Systems

WHAT YOU’LL GAIN FROM THE ISO 13485 INTERNAL AUDITOR TRAINING COURSES?

  • Understand the requirements of ISO 13485:2016 for medical products and related services
  • Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
  • Acquire the skills to take on the position of an internal medical services auditor in the company

ABOUT THE ISO 13485 INTERNAL AUDITOR TRAINING COURSE

To keep quality management system standards relevant to the community of users, ISO 13485:2016, the internationally recognised quality management system standard for the 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 13485:2016 standard.

TRAINING DURATION

  • 2-day instructor-led training

WHO SHOULD ATTEND

This course is specially designed for:

  • Quality and regulatory managers and supervisors
  • Product designers within the medical devices industry
  • Management representatives and consultants
  • Internal QMS auditors
  • External consultants

EXAMINATION & CERTIFICATION

Upon completing the 2-day program, you will get a globally recognised certificate from TÜV SÜD. This reassures potential employers about your skills and knowledge as an auditor for ISO 13485:2016.

LEARNING & CAREER PROSPECTS

As an ISO 13485:2016 internal auditor, you may work in the following industries:

  • Manufacturers of medical devices and systems
  • Contract manufacturer or Original Equipment Manufacturer (OEM) of medical devices
  • Distributors and importers of medical devices
  • Service providers in maintenance, calibration, repair, and technical support
  • Medical devices and systems innovation and development
  • Components and raw material supplier to the OEM or contract manufacturer

It is a possible pathway towards a lead auditor role in the medical devices industry.


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