Ex 120 - Understanding ISO 13485:2002 Quality Standard for the Medical Device Industr


To provide a detailed overview of the new proposed Standard and how the changes will affect a company's quality system, its control and effectiveness. By explaining the philosophy and reasons for the changes we can more fully discuss its impact on regulatory issues and the benefits of customer satisfaction and product improvement. By comparing the proposed standard with ISO9001:2000 and the FDA's QSR requirements we can discuss how to implement the changes, while at the same time maintaining current registrations.

Revision to ISO 9001 has required changes to ISO13485, the Quality System for Medical Device Manufacturers. These changes will set in motion numerous changes to a company's quality system and regulatory compliance. This ONE-DAY workshop is the ideal starting point toward understanding the intent and direction in which the Standard and associated documents are moving; giving insight into reasons behind the changes. This introduction will guide companies toward reviewing current processes and systems, planning for change and understanding the challenges and benefits associated with this projected revision.

Key Session Topics

  • Understand the direct comparison of ISO13485 with the FDA's QSR requirements and ISO 9001:2000 including the development of the Guide ISO9004:2000.
  • Understand the implications of proposed changes to 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 the implications of proposed changes, how it will affect your company systems to be process based not procedural.
  • The approach of Regulators to the proposed changes.
  • Identify changes to Internal Audits, 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

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