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What is ISO 13485?

What is ISO 13485?

ISO 13485:2016 is based on the ISO 9001 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.

Benefits of ISO 13485 Certification

Reduced operating costs

Significant financial savings can be achieved through increased energy efficiency (OFGEM forecast energy prices to rise by at least 20% by 2020).

Improve efficiencies

Encourages a more effective use of your resources, in turn reducing amount of claims, returns, reprocesses and rejections - potentially lower levels of regulatory reporting.

Reduced carbon footprint

Actively set goals to reduce your carbon footprint and people will respond positively to your organization.

Legal compliance

Understand how statutory and regulatory requirements impact your organization and its customers.

Proven business credentials

Independent verification against a globally recognized industry standard speaks volumes.

Ability to win more business

Procurement specifications often require certification as a condition to supply, so certification opens doors.

Ready to start your journey?

We'll give you a clear indication of the costs of gaining and maintaining certification.