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ISO13485:2003 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 gives an overview of all important aspects for managers of an organization in order to implement and maintain an ISO 13485:2003 compliant management system. A successful implementation will demonstrate a company's ability to supply medical devices and related services to customers that comply with regulatory requirements. ISO 13485 is not just product focused, but it focuses instead on the processes used to develop medical devices

Course length

1-3 days are required to complete the ISO 13485 course (doing a couple of hours/day).

Who should attend

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

  • This is the ideal course for anyone who does NOT have time to allocate a full day /days to take a LIVE course on ISO 13485:2003, and who wants to quickly and efficiently understand what ISO 13485:2003 is about.
  • You want to upgrade your knowledge and expertise from ISO 13485:1996 to 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

Your company and all who partake in the QMS and supplier audit activities will benefit from taking ISO 13485 training. It provides training on the standard itself but also on how to lead or conduct internal audits and supplier audits using ISO 19011, the guideline standard on how to audit management systems.

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:
  • The Standard
  • The Process Approach
  • Scope
  • Quality Management System
  • Management Responsibility
  • Resource Management
  • Product Realization
  • Measurement, Analysis and Improvement

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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ISO 13485:2003 Training

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