While ISO 13485 is not a requirement, the sheer wealth of benefits created by getting certified can’t be ignored.
Medical device industry businesses can utilize ISO 13485 at any point in the product life cycle, giving the bonus of flexibility.Īdopting this standard allows access to a step-by-step framework for creating a QMS, allowing users to analyze gaps in the current quality management framework and better monitor where and how improvements can be made. Those in this industry can create a quality management system (QMS) within ISO 13485 standards that guarantee best practices. Specifically, ISO 13485 refers to medical devices and related services. What is ISO 13485?Īs with other ISO certifications, ISO 13485 enables an organization to prove it can consistently and thoroughly meet the requirements of customers and regulatory bodies. The question is, though, how is ISO 13485 for medical device quality management systems different from ISO 9001 for quality management? And who exactly should get certified?Ĭontinue reading to discover everything you need to know about ISO 13485 and its requirements. Its uptake has grown in recent years, with the number of total valid ISO 13485 certificates globally rising from 23,045 in 2019 to 25,656 in 2020. Any organization involved in the design, production, servicing, or installation of medical devices needs ISO 13485 certification to demonstrate its dedication to quality.
