ISO 13485:2012 | Medical Device Standards | NQA

The international Quality Management Systems for the design and manufacture of medical devices can help your company stand out. Find out more!

ISO 13485:2012 or ISO 13485:2016 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain.

Helps You With 

quality control, risk management, legal compliance, traceability and recall, process improvement, product improvement, operational efficiency.

Please note: You can still apply for either 2012 or 2016 versions of ISO 13485. Certificates issued for 2012 version will have validity up to the end of the transition period (March 2019). Learn more about the changes to ISO 13485 here.

WHAT IS ISO 13485?

ISO 13485 is based on the ISO 9001:2008 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.


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 organisations whose services support medical device manufacturers.


  • 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
  • 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.

“I just wanted to say thanks to you and John for your efforts surrounding our recertification audit. The consensus of the Arcamed/Precium team is that we found the entire process professional, instructional and enjoyable. We appreciate your quick response in closing out the audit findings and we are focused on the ongoing effort to make improvements to our business.” James K. Evans, Precium Technologies


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ISO 13485 Transition Checklist