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Introduction/Overview Review of Requirements - ISO 13485

Continual Improvement

Management Systems

Course Length

8 Hours

Max Attendees


Course Description

The overview offers a detailed examination of the ISO 13485 standard, including the structure, management requirements, and registration and auditing processes. Participants will learn the requirements of ISO 13485 and have the opportunity to discuss application and implementation of the standard in their facility using real-world examples.

Course Objectives

  • History of Quality Systems standards – ISO 9000, ISO 13485, etc.
  • The Quality Management System Requirements
    • Requirements of the of the ISO 9001 standard
    • The additional requirements of ISO 13485 and how to interpret them
    • How to integrate these requirements into a company’s existing processes
  • The registration process
    • Selecting your registrar
    • Pre-assessment audit
    • Certification Audit
    • Maintaining your certification
  • Getting your Quality system started
    • When to get started
    • How to get started
    • Who should be involved

Course Outline

Who Should Attend:

  • Executives who need to make decisions about ISO 13485 in their business.
  • Managers who need a comprehensive understanding of quality system standards and how to implement the standards in their facility.
  • Engineers who need an introduction to quality system standards and additional knowledge of them.
  • Supervisors who need to relate the standards to the way they perform their everyday activities.
  • Trainers who want a simple, effective method of explaining the standards to employees.