What is the ISO 13485 standard?
ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices, and that related services consistently meet customer requirements and applicable regulatory requirements. It is designed and intended for use by organizations for the design and development, production, installation, servicing and sales of medical devices.
The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. 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. Organizations certified to ISO 13485 can not claim conformity to ISO 9001.
Connection with national requirements for approval of medical devices
Legal access to markets for products is essential for manufacturers of medical devices. ISO 13485 is often required by national regulations as part of the approval process for medical devices, e.g. for the EU directive on medical devices (Medical Device Directive 93/42/EEC, In Vitro Diagnostic Directive 98/79/EC, Active Implantable Medical Devices 90/385/EEC).
DNV GL - Business Assurance is appointed as a notified body to carry out conformity assessment according to Annex II and V of the Medical Device Directive 93/42/EEC. Manufacturers certified according to ISO 13485:2016 fulfill all the quality management requirements for any class of devices under this directive.
ISO 14969: This standard provides guidance for the application of the requirements for quality management systems contained in ISO 13485. This guidance can be used to better understand the requirements of ISO 13485 as it helps illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.
ISO 14971: This standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories. It also specifies a procedure to estimate and evaluate the identified risks, control these risks and monitor the effectiveness of the control. How can we help you? We are an accredited third party certification body. For certification, you need to implement an effective quality management system complying with the requirements of the standard.