iso13485Introduction to ISO 13485:2012 Quality Standard for the Medical Device Industry


Delivered in-house, this interactive and practical workshop is designed to provide delegates with a basic knowledge of the background, structure and requirements of the Medical Device Directive and CE marking and how the Standard relates to those requirements.

Course Objectives

Providing an overview of the intent and requirements of ISO 13485:2012 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 Skills / Learning Objectives

Through the combination of interactive tutorials and workshops, our course will enable the delegates to:

  • Interpret the basic requirements of ISO 13485:2012 as it relates to quality management systems.
  • Apply the process approach to managing a company's quality system, its control and effectiveness.
  • Compare ISO 13485 with ISO9001 and the FDA's QSR requirements with the view of implementing the Standard.
  • Identify the importance of Design Control, Corrective and Preventative Action (CAPA) and Production and Process Control (P&PC) and how these can add value to processes.

Course Outline

Introduction and overview of the requirements of ISO 13485:2012.

  • Comparison of the requirements of ISO13485 with FDA'S QSR and ISO9001 requirements.
  • Introduction to the Guide ISO/TR14969
  • Risk management requirements and ISO 14971
  • The implications of ISO 13485 for the Medical Device Industry in maintaining registration and market approval.
    • ISO13485 is required by Canada, Japan and Australasia
    • ISO13485 is the direct equivalent to QSR
  • Analysis of a process-based management system and the impact this may have on a company's procedural based system.
  • The approach of Regulators.
  • Sources of information and further development

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 revisions

Booking and Course Fees

Fees include:

  • Delegate workbook, including reference information
  • Training provided by qualified and experienced tutors with extensive practical management auditing experience across a variety of manufacture and service industries
  • Certificate verifying attendance and completion of course

This course is for delivery in-house only. Offering better value for money, in-house training can be customised and designed to meet specific individual and company needs.

Please Contact us to discuss your in-house requirements.

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