ISO 13485:2016 Medical Device Management Systems Internal Auditor

In the pursuit of continual improvement, organisations are constantly embarking on the journey to strengthen their quality management systems and processes with the aim of producing high customer loyalty and satisfaction and building long-term partnerships with them.

To keep quality management system standards relevant to the community of users, ISO 13485, 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.

During the course, you will learn the following:

• 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

The 2-day ISO 13485 internal auditor certification course will follow this structure:

Day 1

• introduction to the Quality Management System
• Overview of ISO 13485:2016 standard
• Comparison and differences between the ISO 13485:2003 and ISO 13485:2016 standards

Day 2

• Terminologies and definitions
• Auditing principles and auditor responsibilities
• Audit planning and preparation
• Conducting opening and closing meetings
• Audit execution
• Provide verbal and written feedback
• Non-conformity reporting
• Audit report preparation
• Audit follow-up

The ISO 13485:2016 internal auditor training and certification program is ideal for:

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

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

• Manufacturers of medical devices and systems
• Contract manufacturer or 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.

The ISO 13485 internal auditor training course content is developed by domain experts with years of experience at TÜV SÜD.

The course curriculum follows the current business landscape and market requirements within the medical devices industry.

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.

1. Can I also attend e-learning courses on top of attending the ISO 13485:2016 Medical Device Management System Internal Auditor course?
Yes, you can register for any e-learning course at TÜV SÜD.

2. How do I enroll for the ISO 13485:2016 Medical Device Management System Internal Auditor course?
To enroll, please click on "Buy now" and check out from your cart.

3. What is the ISO 13485:2016 Medical Device Management System Internal Auditor course methodology?
The 2-day course contains classroom learning, role plays, group exercises, case studies, and discussions on real-life scenarios.

4. Are there any tests in between the ISO 13485:2016 Medical Device Management System Internal Auditor course?
No, there are no in-between assessments. However, there will be case studies included in the ISO 13485:2016 training.

5. Can I get a refund if I cancel my enrollment for the ISO 13485:2016 Medical Device Management System Internal Auditor course?

• If the cancellation request comes less than 14 days before the confirmed training date, no refund will be provided for the training.
• If the cancellation request comes 14 or more days before the confirmed training date, a refund of 50% of the total fee paid will be issued.

6. Do I get a certificate of completion after I do the ISO 13485:2016 ISO 13485:2016 Medical Device Management System Internal Auditor course?
Yes, you get a certificate of completion after doing the 2-day ISO 13485:2016 classroom program.