ISO 13485 Training

About ISO 13485 Internal Auditor Training

ISO 13485 Internal Auditor Training outlines quality management system requirements for design, development, production, and servicing of medical devices and related services. The purpose of ISO 13485 Internal Auditor Training is to provide personnel with the necessary knowledge to plan and conduct an audit of a medical device company in accordance with ISO 13485 Internal Auditor Training standard. ISO 13485 Internal Auditor Training also provides information for the development of an audit program.

ISO 13485 Training

ISO 13485 Internal Auditor Training Course Overview

The ISO 13485 Internal Auditor Training course is composed of six elements:

  • Containment
  • Corrective action system
  • Documentation requirements
  • Product identification and labeling
  • Training requirements
  • Validation

ISO 13485 Internal Auditor Training also covers management responsibilities, including management review and top-level delegation. This ISO 13485 Internal Auditor Training course is designed to enable students to understand and apply ISO 13485:2003 and the relevant Annexes.

ISO 13485 Training Provided by IAS

In addition to ISO 13485 internal auditor training, IAS provides ISO 13485 Awareness Training for all employees of an organization who wish to successfully implement ISO 13485 standards. ISO 13485 Awareness training is designed to provide managers and their employees with an overview of the ISO 13485 standards so that they are comfortable with them. This type of ISO 13485 training helps people understand the system’s Dos and Dont’s, as well as what, when, why, and who should adhere to it. Almost all employees and workers who will be involved in the organization’s installation and usage of ISO systems will receive this type of ISO 13485 training.

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Course Delivery for ISO 13485 Training

There are three types of course delivery for ISO 13485 training provided by IAS:

  • Classroom Method for ISO 13485 Training:  ISO 13485 training can be provided in a classroom environment. A trained course director educates a group of students in a formal learning context. ISO 13485 training will involve interactive lectures, hands-on exercises, and real-life case studies. Special In-House training is available for organizations who wish to give ISO 13485 training in their own facilities during particular business hours.
  • Virtual Classroom for ISO 13485 Training: This type of ISO 13485 training is designed to allow candidates to participate from the comfort of their own homes or offices, regardless of where they are in the globe. Candidates will engage in a live ISO 13485 training session with highly qualified tutors through Zoom Meeting, which will include interactive discussions, face-to-face screen sharing, and live classroom conversations. Take advantage of all the advantages of classroom training from the convenience of your own home or workplace.
  • Self-learning Method for ISO 13485 Training: This ISO 13485 training option is for those who do not have enough time to attend a full live session. Candidates will have access to an online self-study site with all of the necessary study resources. Candidates will be able to complete ISO 13485 training by completing a number of learning modules completely online.

Duration of ISO 13485 Training

  • ISO 13485 Internal Auditor Training: ISO 13485 internal auditor training can be completed at your own speed. Participants will have access to the self-learning portal for 30 days. Once a candidate has finished all of the learning modules, an online examination will be provided. Candidates who pass the test will be eligible for the ISO 13485 Internal Auditor Training Certification. Participants who choose for ISO 13485 auditor training in the classroom will attend a two-day session, lasting 16 hours.
  • ISO 13485 Awareness Training: This ISO 13485 training course is delivered in a self-paced format. Participants will have 30 days to use the online portal. A participation certificate will be given to a candidate if they have completed all of the learning modules. Participants who wish to participate in the live ISO 13485 training will be required to attend a one-day course that will typically take around 3-4 hours.

Benefits of ISO 13485 Training

Attending ISO 13485 Training courses will benefit candidates in a variety of ways. The completion of ISO 13485 training is the first step toward becoming an ISO certified quality expert. Additionally, workers who complete ISO 13485 auditor training and implement the ISO Quality Management System receive certification. ISO 13485 training also helps ISO professionals acquire the knowledge, skills, and abilities they need to compete internationally. The following are just a few of the advantages of ISO 13485 training:

  • Increases your knowledge, allowing you to advance in your career.
  • Make new business connections.
  • Obtain a competitive edge
  • Boost productivity while cutting costs
  • Suggest recommendations about how to make work procedures better.
  • Provide medical equipment that is both safer and more efficient.
  • Increased client retention and satisfaction

For more information on ISO 13485 training or how to apply for ISO 13485 Internal Auditor Training, please contact us or visit our ISO 13485 training frequently asked questions page to learn more.