ISO 13485

About ISO 13485

Customers in the current generation are very demanding. Due to excess of availability of resources they have a plethora of options because of which why they demand so much from the organisations. The health of these customers does play an important role. Health for that matter is a very important aspect of human life.

What is ISO 13485?

The ISO 13485 certainly specifies a core requirement of a system of quality management where the organization is expected to demonstrate its ability to provide the various medical devices and all such related services which meet with the customer requirements. These organizations have the flexibility to be involved in one or various more stages of the life-cycle.

The life cycle includes the following steps and processes:

  • Design and development: Naturally the first step has to be of designing and then the development of the process. The product has to be properly designed properly and then keeping all considerations it needs to be developed as well.
  • Production: Once the product is properly designed and developed, the next is to produce the aspired product. The product should be designed keeping in mind the certifications and all the guidelines.
  • Storage and distribution: Finally, when the product is produced, the excess of the product is stored and distributed accordingly without compromising on the quality.
  • Installation and services: Finally, these medical devices are installed properly. But it does not end here. Once the installation is done after the service is provided on the products.

ISO 13485 is applied to all possible organizations regardless of its size and type.


It's important to note that ISO 13485 is specifically tailored to the medical device industry and focuses on the unique challenges and regulatory requirements of this sector. While it shares similarities with other quality management standards like ISO 9001, ISO 13485 places a greater emphasis on aspects related to medical device safety, effectiveness, and regulatory compliance.

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