ISO 13485: Quality Management System for Medical Devices

ISO 13485 is one of several standards published by the International Organization for Standardization (ISO) which provides specific requirements for quality management systems within organizations involved with medical device design and manufacturing. It was first introduced in 1996 and has since been updated multiple times, most recently being revised in October 2016. This standard applies specifically to manufacturers of active implantable and non-implantable medical devices and related accessories.

The purpose of this standard is to ensure that companies meeting these criteria have a well-developed quality management system that focuses on ensuring patient safety and product reliability. It helps monitor compliance with other relevant regulatory requirements such as those imposed by the Food & Drug Administration (FDA). Compliance with this standard simplifies conformity assessments because it demonstrates stringent controls over procedures throughout all stages of production.

To achieve certification under ISO 13485, a company must demonstrate effective control of processes and services from initial concept through delivery. These controls cover areas including risk analysis, traceability, document handling, and change management among others. Achieving registration indicates that a firm's products comply with the requirement set forth by regulators concerned with patients’ health, thus making them safer for consumers worldwide.

In summary, ISO 13485 specifies the necessary administrative steps to obtain a certified quality management system suited for medical device manufacturing. By implementing and maintaining a process focused on quality, firms can increase their credibility while simultaneously improving efficiency and reducing costs associated with defective goods.