What is ISO and ISO 13485?

What is ISO

ISO is an independent international organization established in 1947 with a membership of 169 national standards bodies. ISO develops and publishes international standards. Until now, ISO has published over 20,000 international standards, covering technology, management, manufacture, etc. Each international standard will be updated and revised according to the current situation, and the year of publication will be added after the name of the guidelines. However, ISO is not responsible for institutional certification which external certification agencies perform.

What is ISO 13485

There are different requirements for market approval of medical devices and general commercial products when user safety is taken into consideration. Each country has its own regulations, such as the Taiwan Medical Device Management Law, the United States 21 CFR 820, the European Union MDR, and the Chinese Medical Device Supervision and Administration Regulations. These regulations all refer to ISO 13485.

The current edition of ISO 13485-Quality Management for Medical Devices was published on 1 March 2016. Based on ISO 9001 quality management system, ISO 13485 was established and tailored to the medical device industry. It provides guidelines to medical device manufacturers or suppliers on how to plan, develop, and maintain internal quality systems. ISO13485 draws up standards for the facilities, equipment, organization and personnel, production, quality control, storage, distribution, handling of customer complaints, and other matters for the manufacturers of medical devices. This is to ensure that the product is consistent and meets the declared intended use throughout its entire life cycle, including design, development, manufacturing, storage, and transportation.

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