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.