ISO 13485:2003

What is ISO 13485:2003?

  • ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices.
  • Its primary objective is to facilitate harmonized medical device regulatory requirements.
  • The standard contains specific requirements for manufacture, installation and servicing and calls for:
  • Implementation of a Quality Management System with several enhancements
  • Risk Management approach to product development and product realization
  • Validation of processes
  • Compliance with statutory and regulatory requirements
  • Effective product tractability and recall systems

Who is ISO 13485 applicable to?

ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

What are the benefits of certification?

  • Customer satisfaction – through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements
  • Reduced operating costs – through continual improvement of processes and resulting operational efficiencies
  • Improved stakeholder relationships – including staff, customers and suppliers
  • Legal compliance – by understanding how statutory and regulatory requirements impact the organization and its customers
  • Improved risk management – through greater consistency and tractability of products and use of risk management techniques
  • Proven business credentials – through independent verification against recognized standards
  • Ability to win more business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector
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