What is ISO 13485 – Quality Management for the Medical Device Industry?

The ISO 13485 is similar to the other international standards of ISO. In fact it is very similar to ISO 9001 which is something to do with quality management. However the ISO 13485 is about the manufacturing of medical devices and the quality management system that needs to be in place for such organizations.

Hence the question “What is ISO 13485?” can be answered in a more descriptive manner like this: In general there are regulations regarding the manufacturing of medical devices however what ISO 13485 does is makes sure that this quality level is at a high standard such that it is internationally recognized by most firms around the globe and customers too.

The Certification process

The certification process for ISO 13485 is similar to other ISO standards in the sense that it is possible to take the help and support of an ISO 13485 consultant to achieve the target of being compliant with the requirements for certification which would be later followed by the audit for certification. The process goes like this:

  • Identify the requirements and how they are applicable to your organization

  • Analysis and access the state your organization and the effort and cost needed to gain compliance.

  • Planning each stage toward the final goal is an important step of this process.

  • Preparing for final assessment with a pre-assessment check always pays off.

  • Finally the official assessment is where everything should fall in place and be ready.

Kelmac International is a Medical Device Certification Consultant

Kelmac International can help with process of ISO 13485 certification in more ways than one. They have an edge having been involved with clients in several countries around the world, some of which are even the fortune 500 companies.


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