ISO 13485 Training

About ISO 13485 Training

ISO 13485 is an ISO standard that establishes requirements for medical device manufacturer’s quality management systems. On January 1, 2016, ISO released the newest version of this standard, ISO 13485:2016. ISO 13485 training courses can help companies better understand and apply quality management criteria in the design, production, installation, and servicing of medical equipment.

ISO 13485 Training

Types of ISO 13485 Training

ISO 13485 Training Level 1: Awareness

The purpose of this type of ISO 13485 training is to give managers an overview of the ISO 13485 standard so that they are familiar with it. This awareness fosters comprehension of the system’s Dos and Don’ts, as well as what, when, why, and who should follow it. This form of ISO 13485 training is delivered to almost all employees and workers who will be involved in the organization’s installation and use of ISO systems.

ISO 13485 Training Level 2: Internal Quality Auditor 

This type of ISO 13485 training teaches staff how to use an audit checklist to conduct an audit, document non-conformities, and verify corrective actions. Internal audits must be performed by competent individuals according to every ISO standard. As a result, this ISO 13485 training has risen in popularity and is now widely employed by all firms to instruct their employees.

ISO 13485 Training Level 3: Lead Auditor

This ISO 13485 auditor training is the highest level of ISO 13485 certification training. The ISO 13485 Lead Auditor course is designed to provide participants with the knowledge and abilities necessary to plan, perform, and report a Medical Device Management System audit utilizing the proper audit concepts, methods, and methodologies. Employees will also learn how to perform third-party ISO audits in accordance with ISO 13485 guidelines in this training. ISO 13485 auditor training is recommended for those who have past experience with Quality Management Systems and want to improve their careers as external third-party auditors for companies all over the world.

ISO 13485 Training: Mode of Delivery

ISO 13485 training can be conducted in a variety of ways:

On-Site/Classroom Training 

ISO 13485 auditor training courses can be delivered in a classroom setting. In a formal learning setting, a trained course director instructs a group of pupils. Interactive seminars, hands-on activities, and real-life case studies will be included in ISO 13485 training. Organizations who want to provide training in their own facility during specific business hours might take advantage of special In-House training.

Virtual Classroom

This form of ISO 13485 training is designed to allow applicants to participate from the comfort of their own homes or offices anywhere in the world. Candidates will participate in a live training session through Zoom Meeting, with highly skilled tutors who provide interactive discussions, face-to-face screen sharing, and live classroom chats. Enjoy all of the benefits of classroom training at the comfort of your own home or office.


This form of ISO 13485 training is for people who don’t have enough time to attend a complete live session. Candidates will have access to an online self-learning portal that will contain all of the relevant study materials. By completing a series of learning modules, candidates will be able to finish ISO 13485 training.

Duration of ISO 13485 Training

Lead Auditor Training: The training is normally 5 days long, with a total of 40 hours of instruction. On the concluding day of the course, there will be an examination. The ISO 13485 Lead Auditor Training Certification will be offered to candidates who pass the exam.

Internal Quality Auditor Training: This ISO 13485 auditor training is delivered in a self-paced format. The self-learning portal will be available to participants for 30 days. An online examination will be offered once a candidate has completed all of the learning courses. The ISO 13485 Internal Quality Auditor Certification will be offered to candidates who pass the exam. Participants who choose the Classroom mode of delivery for ISO 13485 auditor training will attend a 2-day workshop, totaling 16 hours. 

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. Participants who want to attend the live ISO 13485 training will attend a one-day workshop, typically lasting 3-4 hours. 

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Advantages of ISO 13485 Training

Candidates will profit in a variety of ways by attending ISO 13485 Training courses. The first step in becoming an ISO certified quality expert is to complete ISO 13485 training. Additionally, ISO 13485 auditor training offers certification to employees who complete the course and uses the ISO Quality Management System (QMS). ISO 13485 Training also aids in the development of the information, skills, and abilities that ISO professionals require in order to be globally competitive. The following are just a handful of the benefits of ISO 13485 training:

  • Increases your knowledge which enables job growth 
  • Form new business relationships
  • Get a competitive advantage
  • Increase efficiency while lowering costs
  • Give suggestions for ways to improve work processes
  • Provide safer and more efficient medical equipment
  • Increase in customer satisfaction and retention

Contact IAS today to learn more about ISO 13485 training, or visit our ISO 13485 training frequently asked questions page!