ISO 13485 Internal Auditor - Australia

Prerequisites

There are no formal prerequisites for attending this ISO 13485 Internal Auditor Training course.

Audience

This course is intended for everyone who wants to enhance their knowledge of quality management systems for medical devices and auditing techniques to meet the ISO requirements. 

ISO 13485 Internal Auditor Course Overview

ISO 13485 defines the requirements for a Quality Management System (QMS) in situations where an organisation must demonstrate its ability to consistently offer medical devices and related services that fulfil customer and applicable regulatory requirements. An ISO 13485 audit helps to identify the present state and health of your QMS and processes. It comprises an independent and systematic process audit to determine QMS's conformity or nonconformity. This training session equips learners with the auditing techniques of quality management systems following ISO 13485 and ISO 19011. Individuals with excellent auditing skills in medical devices will get higher designations and expand their professional networks within a short period.  

In this 2-day ISO 13485 Internal Auditor Training course, delegates will gain comprehensive knowledge of quality management systems and how to conduct internal auditing. During this training, delegates will learn about the management's responsibilities for making policy and financial decisions to support QMS. They will also learn how to plan a medical device and quality process audit and the documentation requirements. Our highly skilled and knowledgeable instructor with years of experience teaching ISO courses will conduct this training.  

Course Objectives

• To carry out activities in order to achieve audit objectives
• To provide products and services to medical device organisations
• To enhance the organisational ability and meet customer requirements
• To identify the context of a company as well as internal and external issues
• To create a culture of continual improvement and improve decision-making
• To maintain records and implement quality processes within an organisation

After attending this training, delegates will be able to promote awareness of regulations and review the management to identify improvements and regulatory requirements. They will also be able to evaluate the effectiveness of the quality management system and document each test during processing. 

What's included in this ISO 13485 Training Course?

This training course includes:

• The ISO 13485 Internal Auditor Examination
• The Knowledge Academy ISO 13485 Internal Auditor Manual 
• Certificate
• Experienced Instructor 
• Refreshments 

ISO 13485 Internal Auditor Exam

In order to complete this ISO 13485 Internal Auditor training course, delegates will need to pass the associated examination. The exam is:

• Multiple choice questions
• Duration of 40 minutes
• 50% pass mark
• Closed book