QHS050

Medical devices -- Quality management systems -- Requirements for regulatory purposes

ISO 13485:2016 is a standard for quality management systems for medical devices. It is based on ISO 9001:2008 and was first published in 1996. The current version came into effect in March 2016. The standard is designed for organizations involved in the design, production, installation, and servicing of medical devices and related services. It can also be used by certification bodies and other external and internal parties to help with their auditing processes. The standard's requirements include: Adhering to the standard Documenting what needs to be documented Maintaining what is required Having written procedures in place and ensuring the effectiveness of the system Considering risk factors in all activities The standard's purpose is to facilitate harmonized medical device regulatory requirements. It focuses on how companies should manage decisions related to purchasing, design, development, production control activities, and other aspects of the quality management system.