Understanding ISO 13485:2003


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Overview

ISO 13485 was prepared by Technical Committee ISO/TC 210 for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.  This course is designed to provide participants with a fundamental understanding of the internationally recognized ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes. The elements of the standard are covered in detail, with special emphasis on the various ways that manufacturing or service organizations can meet the requirements.

Approach

Taught as a traditional classroom seminar, this two day course provides participants an opportunity to learn through the examination of real-life case studies, breakout sessions and classroom discussions.

Participants will:

  • Understand the medical devices quality assurance standards
  • Understand how the standards are applicable to their organization
  • Know the benefits & costs of registration
  • Become familiar with alternative approaches to registration
  • Know how to create the required documentation
  • Understand the concepts of how to maintain the registration
  • Be ready to implement ISO 13485

What You Will Learn

Fundamentals of ISO 13485:

  • Definition of Quality
  • Quality Control
  • Medical Devices Quality Assurance
  • Why ISO 13485?
  • When to pursue ISO 13485?
  • Benefits—tangible and intangible
  • How ISO 13485 integrates with your overall company improvement program
  • Typical costs
    • Initial registration
    • On-going maintenance
  • History of ISO 13485
  • Applicable standards & guidelines
  • The registration process
  • Internal and external audits
  • How to achieve registration
    • Creating the overall project plan
    • Project timeline
    • Differing approaches to registration
    • Rapid vs. slow approach
    • Developing documentation
    • Implementing the requirements
    • Conducting audits
  • Using a consultant
    • Typical consultant approaches
    • Selecting the consultant that’s best for you
    • Measuring consultant performance
  • Review of the elements of ISO 13485
  • Examples of ISO 13485 documentation
  • Post-registration marketing strategies
  • Obstacles to ISO 13485 registration
    • Strategies for overcoming obstacles

Training Outcomes

This course is primarily targeted at people who are driving the creation of company-wide quality management systems. Other people who may consider attending include management personnel and/or owners of companies that are interested in ISO 13485.

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