ISO 13485:2003 Internal Auditor Training
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ISO 13485:2003 Internal Auditor Training

ISO 13485:2003 Internal Auditor Training

Seminar Content

ISO 13485 is a Quality Management Standard for Medical Devices. 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. This course meets the training portion of the requirements for certification of individual internal auditors. The seminar will include an explanation of ISO 13485:2003 and audit systems, the auditing process and audit instruments; documentation process, how to conduct an audit, how to write the audit report, and take corrective action; auditing case studies to develop skills for identifying nonconformance. 3 day seminar.

Who Should Attend

Quality Assurance Managers, ISO 13485:2003 Implementation Team Members, Management Representatives, and ISO 9001:2000 Internal Auditors should attend this seminar.

Recommended Training and/or Experience

Understanding & Implementing for ISO 13485:2003 or equivalent is suggested.

Seminar Materials

Seminar manual with case study and guide for auditing the standard will be provided to participants.

Seminar Goals

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

Seminar Outline

Day 1

  • Introduction and Welcome
  • The Challenge for Top Management
  • Eight Quality Management Principles
  • The ISO Standard Explained
    • Family of Standards
  • Overview of ISO 13485:2003 Requirements
    • Exclusions
  • Overview of ISO 13485:2003 Requirements: Clause 4
  • Overview of ISO 13485:2003 Requirements: Clause 5
  • Overview of ISO 13485:2003 Requirements: Clause 6
  • Overview of ISO 13485:2003 Requirements: Clause 7
    • Audit Plan (Study/Homework)

Day 2

  • Overview of ISO 13485:2003 Requirements: Clause 8
  • Introduction to ISO 13485:2003 Audit Trails
  • Documentation for ISO 13485:2003
  • Introduction to Quality Audits
  • Management of Audit Programs
  • Audit Planning and Preparation
    • Scope and Objectives
    • Audit Plan
  • Performing the Audit
    • Opening Meeting
    • Quality Audits

Day 3

    • Conducting the Audit
  • Writing Nonconformity Statements
    • Writing Nonconformities (using CARs)
  • Closing Meeting
    • Summary Statement and Closing Meeting
  • Completing the Audit Report
  • Corrective Action and Close Out (using CARs)
    • Verification and Close Out

Course Sequence: 13485IAT

About ISO 13485 2003
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. The European medical device quality system standard as of this writing is EN ISO 13485:2003. ISO 13485:2003 will replace current harmonized standards EN ISO 13485:2000 and EN ISO 13488:2000 after a three year transition ending in July 2006. more...


Omnex Systems Webinar - Managing Audits Globally Using Best Practices - October 29, 2005 (12 MB Webex file)Download Webex Player

Download Complete Global Medical Device Regulations and Information
Download Complete Global Medical Device Regulations and Information

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