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ISO 13485 :2003 Lead 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 online course trains and helps auditors to:

  • Understand the Quality Management Principles
  • Interpret All Clauses of ISO 13485:2003
  • Apply Principles of PD ISO/TR 14969:2004 and ISO 14971:2001
  • Apply ISO 19011:2002 Definitions, Concepts, and Guidelines
  • Apply Principles of ISO 19011:2002 to the Auditing Process Manage an Audit Program
  • Understand the ISO 13485 :2003 Registration Process

Course length

5-6 days (doing a couple of hours/day) are required to complete the ISO 13485:2003 lead auditor course.

Who should attend

Anyone who wants to quickly and efficiently understand and learn how to audit or lead an audit using the QMS and EMS auditing guideline to ISO 19011.

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

  • Want to quickly and efficiently learn how to lead an ISO/TS 16949:2009 audit
  • Want to quickly and efficiently be trained on ISO/TS 16949 (the standard), and ISO 9000 (the vocabulary for the standard)
  • Want to be a lead auditor to conduct internal audits and supplier audits for your company
  • Want to improve your CV and career opportunities with qualifications in quality assurance and leading 1st part audits
  • Want to upgrade your expertise from auditing QS 9000 to ISO/TS 16949:2009
  • Want to upgrade your expertise from auditing with ISO 10011-1 to ISO 19011:2002
  • Do NOT have time to allocate two days to take an auditor class
  • Want to train more of your staff on auditing 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:

  • Master the auditing techniques per ISO 19011, which are used for quality, environmental, and safety management system audits
  • Learn how to prepare and conduct an audit
  • Be exposed to real auditing case studies covering many industries

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
  • 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
  • Industry 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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