ISO 13485 Medical Devices Management Systems

ISO 13485 is based on the ISO 9001:2000 process model approach and 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 realisation.
  • Validation of processes.
  • Compliance with statutory and regulatory requirements.
  • Effective product traceability and recall systems.

Who can use ISO 13485?

ISO 13485 contains requirements that are essential for any organisation 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 organisations whose services support medical device manufacturers.

What are the benefits of ISO 13485 Registration?

  • 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 organisation and its customers.
  • Improved risk management
    through greater consistency and traceability of products and use of risk management techniques.
  • Ability to win more business
    Procurement specifications often require certification as a condition to supply, so gaining certification opens doors.
  • Proven business credentials
    through independent verification against recognised standards.
  • Ability to win more business
    particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.

To obtain more information about these services, please contact our team immediately. We will graciously and happy to serve you.