Iso 13485 Quality Management System For Medical Devices

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

. ISO 13085 is an ISO standard Published in 2003.



ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability and excludes some of the requirements of ISO 9001 that are not necessary as regulatory requirements.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and amputates some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. The standard can be used by manufacturers to demonstrate applicable regulatory requirements, and by other organizations whose related services support medical device manufacturers.

The certification of a high quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market. A manufacturer must have the quality procedures that are documented, controlled, and effectively applied and maintained. The ISO 13485 is not a product standard, its process oriented.

Advantages of ISO 13085

- Ensure that all of our products comply with relevant safety and regulatory requirements.

- Focus on risk management activities and design transfer activities during product development.

- Continually monitor the quality of our customer interactions, with the intent to improve our customer's total experience.

- Requires specific for documentation and validation of processes for sterile medical devices.

- Ensuring that personnel have the right experience, education, training, and skills. Acceptable levels of competence must be defined. Training needs must be established and assessed. A record of competence must be maintained.

by: Kevin Meaney

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