Ex 120 - Understanding ISO 13485:2003 Quality Standard for the Medical Device Industry

Overview

To provide a detailed overview of the Standard and the process approach to managing a company's quality system, its control and effectiveness. To explain the background, structure and requirements of the Medical Device Directive and CE marking and how the Standard relates to those requirements. By comparing ISO 13485:2003 with ISO9001:2000 and the FDA's QSR requirements we can discuss how to implement the standard.

The Standard ISO13485:2003 is the Quality System Standard for Medical Device Manufacturers. This ONE-DAY workshop is the ideal starting point toward understanding the intent and requirements of this Standard and the related guides and standards. This introduction will guide companies in reviewing current processes and systems, planning how to implement the Standard and understanding the challenges and benefits associated with the process approach to managing the quality management system.

Key Session Topics

• Understand the detailed requirements of the Standard.
• Understand the comparison of the requirements of ISO13485:2003 with FDA'S QSR and ISO9001:2000 requirements.
• Introduce the Guide ISO/TR14969
• Explain risk management requirements and briefly discuss ISO14971
• Understand the implications of the Standard for the Medical Device Industry in maintaining registration and market approval.
  • ISO13485 is required by Canada, Japan and Australasia.
  • ISO13485 replaces EN46000 in EC.
  • ISO13485 is the direct equivalent to QSR
• Analyze how it will affect your company systems to be process and not procedural based.
  
• Study the approach of Regulators.
  
• Identify the importance of Design Control, Corrective and Preventative Action (CAPA) and Production and Process Control (P&PC). How to make them add value to your processes.

Who Should Attend

• Executives and Senior Management
  
• General Managers/Business Unit Managers
  
• Quality and Regulatory Professionals
  
• Management Representatives/Internal and External Auditors
  
• Those seeking an understanding of the proposed revisions