ISO 13485 Training

About ISO 13485 Training 

ISO 13485 is the ISO standard that specifies requirements for a comprehensive quality management system for manufacturers of medical devices. ISO 13485:2016 was published by ISO on January 1, 2016. Any firm involved in the design, production, installation, or servicing of medical equipment can benefit from ISO 13485 training courses to better understand and apply quality management requirements.

medical devices

ISO 13485 Training Levels

Level 1. Awareness ISO 13485 Training

The goal of awareness training is to provide managers with an overview of the ISO 13485 standard so that they are familiar with the process. This awareness develops an understanding of what, when, why, and who should follow this system, as well as the system’s Dos and Don’ts. Almost all employees and workers who will be involved in the organization’s implementation and use of ISO systems are given ISO Foundation training. 

Level 2. Internal Quality Auditor ISO 13485 Training 

The goal of internal quality auditor training is to teach employees how to conduct an audit using an audit checklist, record non-conformities, and verify corrective actions. Every ISO standard mandates that internal auditors be completed by competent employees. Therefore, this training has grown increasingly popular and widely used by all organizations to teach their workforce. 

Level 3. Lead Auditor ISO 13485 Training 

The lead auditor course is the most advanced level of ISO 13485 training. The ISO 13485 Lead Auditor training is designed to give participants the information and skills they need to plan, conduct, and report a Medical Device Management System audit using the appropriate audit principles, processes, and techniques. This course will also teach employees how to conduct third-party ISO audits in compliance with ISO 13485 guidelines. Lead auditor ISO 13485 training is recommended for those who have prior knowledge of Quality Management Systems and who are looking to advance their careers by becoming external third-party auditors for organizations across the globe. 

Mode of Delivery for ISO 13485 Training

There are several ways ISO 13485 Training is conducted:

  • Classroom / In-House Training

This type of ISO 13485 training is conducted in a classroom setting. A qualified course director instructs a group of students in a formal learning environment. The training will consist of interactive sessions, hands-on activities, and real-life case studies. Special In-House training is designed for organizations that would like to conduct training in their own building at specified business hours. 

  • Virtual Classroom

This type of ISO 13485 training is designed so that candidates can participate all over the world from the comfort of their own homes or offices. The structure will be similar to the in-house training program, with candidates attending the live training session via Zoom Meeting. 

  • Self-Learning 

This type of ISO 13485 training is designed for candidates who may not have the time to attend a full live session. Candidates will have access to an online self-learning portal, where all the necessary study material will be easily available. Candidates will be able to complete ISO 13485 training by completing a series of learning modules.

ISO 13485 Training Duration

Lead Auditor Training: The course will typically run for 5 days, for a total of 40 hours. An examination will take place on the last day of the course. Candidates who pass the examination will be awarded ISO 13485 Lead Auditor Training Certification. 

Internal Quality Auditor Training: This type of ISO 13485 training is taught via self-learning mode. Participants will have access to the self-learning portal for 30 days. Once a candidate completes all of the learning modules, an online examination will be given. Candidates who pass the examination will be awarded ISO 13485 Internal Quality Auditor Certification. 

Awareness Training: This type of ISO 13485 training is taught via self-learning mode. Participants will have access to the portal for 30 days. Once a candidate completes all of the learning modules, a Participation certificate will be awarded.

Benefits of ISO 13485 Training

By attending ISO 13485 Training courses, candidates will benefit in many ways. ISO 13485 training is the first step to becoming an ISO certified quality professional. Furthermore, it provides certification opportunities for employees who participate in this training and implements the ISO Quality Management System (QMS). Furthermore, ISO 13485 Training also helps develop the knowledge, skills, and abilities ISO professionals need to be globally competitive. The following are just a few advantages of ISO 13485 training: 

  • Increase the number of employment opportunities
  • Make new business contacts
  • Gain a competitive edge
  • Increase efficiency and cut costs
  • Provide advice on how to improve work processes.
  • Provide medical equipment that is safer and more efficient.
  • Increased customer satisfaction