"What is ISO 13485 quality management system?

Vincent218

ISO 13485 is a quality management system designed specifically for the medical device industry. It covers all aspects of the design, manufacture, and distribution of medical devices. The standard is based on the ISO 9001 quality management system, but with additional requirements specific to the medical device industry.

Whiteko358

ISO 13485 is an international quality management system standard for organizations that design and manufacture medical devices. It is based on the ISO 9001 standard and specifically addresses the quality system requirements appropriate for the design and manufacture of medical devices.

The standard is designed to be used by organizations that design and manufacture medical devices, as well as those that provide support services for medical devices.

The standardISO 13485:2016 can be used by any organization regardless of its size or product complexity.

linda_rice

The ISO 13485 quality management system is a set of requirements and guidelines that organizations can use to ensure that their products and services meet customer and regulatory requirements. The standard is based on the ISO 9001 quality management system, but includes additional requirements specific to the medical device industry.

There are a number of benefits to implementing an ISO 13485 quality management system, such as:

improved product quality
reduced defects and product recalls
improved customer satisfaction
reduced costs associated with rework, repairs, and warranty claims

For more information on ISO 13485, including a downloadable copy of the standard, please visit the ISO website.