ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain. Why was ISO 13485 revised and what are the main improvements?Īll ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. Following consultation with interested parties in November 2018, a decision has now been made by the relevant Technical Committee, ISO. Even before that transition period had ended moves were being made to revise the standard. Read more about certification to ISO’s management system standards. Why was ISO 13485 to be revised so soon The last ISO 13485 revision was published in 2016 and the transition period for migration to this version ended in March 2019. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.