#Iso 13485 updates iso
As of March 1, 2018, all medical device certifications and certification renewals are required to align with the ISO 13485:2016 standard, which supersedes ISO 13485:2003.The standard was updated to adjust to technological advancements, modernized quality management practices and an increased regulatory focus on risk. The last date of validity of the previous standards (ISO 13485:2003 and ISO 13485:2012) will be February 28th, 2019. 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. The Importance of ISO 13485 QMS Software. 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. Read more about certification to ISO’s management system standards. 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. The European version of the international medical device quality management systems standard, EN ISO 13485:2016+A11:2021, has been updated with new annexes demonstrating the link between specific clauses of the standard and the general safety and performance requirements (GSPR) of the Medical Device and IVD Regulations.
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.
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