ISO 13485 Certification Sander Electronics

ISO 13485 is known as Medical Devices Quality Management Systems Standards. It is enacted by International Organization for Standardization which 2016 is the latest version.

ISO 13485 is written based on ISO 9001, with some provisions added or deleted in response to the characteristics of the medical device industry. ISO 13485 emphasizes risk management, verification (confirmation), and strengthening of the supplier’s control process, becoming a single-use standard.

Although ISO 13485 is based on ISO 9001, but a company that only complies with the ISO 13485 standard cannot claim that it also complies with the ISO 9001 standard.

Applying for ISO 13485 not only needs to have all the compliance elements of factory registration, but also requires program review materials and related forms. Before applying for certification, the factory management system must be effectively operated for at least three months and a complete internal audit and management review must be conducted. And you need to pay attention to whether the product is “finished product” or “semi-finished product”.

If it is a finished product, it must be confirmed whether it is recognized as a medical device, because the definition of a medical device is slightly different in each country, and the application for ISO 13485 must be defined as a medical device before it can be applied. For example: massage equipment is not recognized as medical equipment in Taiwan, but it is recognized as medical equipment in Thailand.

If the product is a semi-finished product, as long as it’s proven to applied on medical equipment, and there are trial production or mass production records, all of them meet the requirements for ISO 13485 application.

Sander applied for certification using a self-developed and designed light-therapy helmet, but as explained above, the product needs to be confirmed as a “finished product” or a “semi-finished product” before verification. After sending the relevant application documents and materials to the verification unit for confirmation, due to the differences in the identification of medical devices, it took a lot of time to clarify back and forth from August to December 2021, and finally the certification determined that Sander’s “light-therapy helmet” is not a medical device, so it cannot apply for ISO 13485 verification.

In order to confirm that Sander’s “light-therapy helmet” is a medical device, after inquiring a number of times between different veriation company, at last Sander got SGS to conduct ISO 13485 verification.