ISO 13485 “Medical Devices Quality Management System“ is the internationally recognized standard for quality management systems in the medical devices industry
ISO 13485 is aimed at organizations involved in the entire life-cycle of medical devices, from design to production and subsequent activities, including decommissioning and disposal. It also covers areas such as logistics, distribution, service, testing, calibration, sterilization, etc., and can be used by organizations that produce raw materials, components and sub-assemblies.
The main objective of ISO 13485, in an industry that is highly regulated worldwide, is to promote global harmonization of the requirements of regulations governing medical devices. Choosing to certify your system in accordance with this standard demonstrates your commitment to achieving continuous improvement and giving customers confidence in your ability to bring safe products to the market.
For medical device manufacturers subject to conformity assessment procedures by a Notified Body in accordance with the annexes II, V, and VI, certification to ISO 13485 provide the necessary evidence of quality system conformity. For manufacturers of class I medical devices, who are not subject to assessment by a Notified Body, certification enables direct, independent verification of activities relating to the devices, in preparation for any surveillance activity that may be carried out by the Ministry of Health.
The standard specifies the requirements for quality management systems that enable an organization to demonstrate its ability to supply medical devices and related services that meet customer needs and conform with the applicable regulatory requirements.
Since it is recognized as a harmonized standard under the directives governing the market release of medical devices, ISO 13485 can be used by manufacturers as a reference for the implementation of quality systems within the framework of regulatory procedures governing the design, production and market release of medical devices.
ISO 13485 certification, which organizations can apply for regardless of their size, helps improve overall performance, eliminate uncertainty, manage risk (identified in relation to the safety and performance of the medical device for end-users) and extend market opportunities. Companies in possession of this certification demonstrate their commitment to quality to all stakeholders, whether end-users, customers or regulatory authorities.
Implementing and certifying a quality management system is a highly effective means of optimizing resources and preventing and managing clinical risks and emergency situations. Certification enhances company image and consequently increases the confidence of users, by reassuring them that the medical device complies with the applicable safety and performance requirements. To sum up, an ISO 13485 certified management system helps organizations involved in any phase of the medical device life-cycle to: