ISO 13485

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

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Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485, ISO 13488, or ISO 14971 by a Conformity Assessment Body (CAB). The result of a positive assessment is the authorization for the CE-identification and the permission to sell the high quality medical device in the European Union.

ISO 13485:2003, based on the ISO 9001:2000 process model, suggests that the application and management of a system of processes is an effective way to ensure good quality management. All requirements of this International Standard are specific to organizations providing Medical Devices, regardless of the type or size of the organization.