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ISO 13485 :2003 Auditor Training


ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems ISO 13485:2003 an international standard designed to orient quality management systems toward the design, development, production, and installation of medical devices and related services. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488(also 1996).

Many medical device companies are utilizing ISO 13485:2003 as a platform to build their business management systems because of its benefits or because it is a necessary step to market their products and services in certain regions. For many companies, registration to ISO 13485 is a key to securing and maintaining global business.

Course objective

This course has been specifically designed to meet the needs of the Medical Device Industry and is for individuals responsible for planning and scheduling an audit program for ISO 13485 and those who must perform audits to ISO 13485 for quality assurance. It provides in-depth understanding of the ISO 13485 Audit Process.

Course length

2-3 days are required to complete the ISO 13485 auditor course (doing a couple of hours/day).

Who should attend

This is the ideal course for anyone who wants to quickly and efficiently learn how to audit to ISO 13485:2003, upgrade his/her expertise from auditing ISO 13485:1996 to ISO 13485:2003, and upgrade his/her expertise from auditing with the guidance ISO 10011 to ISO 19011.

This 7Step/CALISO online training course is for you if you:

  • You want to quickly and efficiently understand what ISO 13485:2003 is about,
  • You want to upgrade your knowledge and expertise from ISO 13485:1996 or ISO 9000:1994, EN 46001 to ISO 13485:2003,
  • You do NOT have time to allocate a full day to take a LIVE class on ISO 13485:2003,
  • You want to train more of your staff on ISO 13485:2003 economically and without having to immobilize them in a class for a full day,

Course Benefits

By participating in this 7 Step/CALISO online course, you will be able to:

  • Understand each element of ISO 13485:2003
  • Understand the ISO 13485:2003 auditing and registration process
  • Prepare, perform and complete an audit

Major topics include:

The structure of the training is as follows:
  • Definitions
  • Types Of Audits
  • Audit Objectives
  • Roles And Responsibilities
  • Auditor Activities
  • Initiating The Audit
  • Preparing The Audit
  • Executing The Audit
  • What The Auditor Is Looking For
  • Audit Documents
  • Audit Techniques: Tell Me/Show Me
  • Audit Techniques: Audit Path
  • Audit Techniques: Gradual Elevation
  • Audit Techniques: Sampling
  • Audit Completion And Corrective Action Follow-Up
  • Medical Device Case Studies

Authors: CALISO Corporation


Required Prerequisites

This is an internet-delivered course featuring graphical presentation screens with text-based instruction, videos, and on-going quizzes to reinforce learning and retention and gauge your understanding of a topic before you move forward. Convenient and portable, this course provides instruction without the expense of travel and time away from the workplace.

  • Internet Access
  • Browser cookies enabled
  • Recent browser such as Internet Explorer, Firefox, Chrome or Safari recommended

Award of Certificate

An online training certificate will be issued upon successful completion of the course and obtaining 70% or above on the final average of the ongoing quizzes. A final Exam is provided for trainees who have less that 70%.

With your registration, you will receive online access to the course until you complete it. The limit on course completion and access to your certificate is three years.

Quantity Discounts

Quantity discounts of 15% for 10 or more students registered. The discount is automatically calculated during registration by credit card.

Course Registration

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Your satisfaction is guaranteed. If you register to any of our online courses and are not satisfied with the content, let us know within 30 days of registration, and BEFORE you complete the course or are issued the online certificate: we will refund 100% of the registration fee. We are confident, that like our many other trainees, you will like any course we offer, take some of our other courses, and also recommend them to others. We are proud of our achievement, and want to show it through the explicit satisfaction guarantee that other trainers cannot offer.

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