ISO 13485

  • / ISO 13485

ISO 13485 Quality Management System - Requirements for regulatory reasons

ISO 13485 can be described as an ISO standard, first published in 2003. It outlines what is required for creating a complete management system for the development and production of medical devices (clarification required[clarification needed]. The standard replaces earlier documents like EN 46001 as well EN 46002 (both 1997) and ISO 13485 published in 1996 and ISO 13488 (also 1996).

While it’s a standalone documents, ISO 13485 is generally aligned in accordance with ISO 9001. One of the major differences however can be found in the fact that ISO 9001 requires the organization to show continuous improvement while ISO 13485 requires only that they show that their quality system has been implemented and maintained.

Other differences that are specific to each are:

  • the dissemination and understanding of regulations as a managerial responsibility. A good example of market-specific regulations includes the 21 CFR 820, Quality System Regulation for Medical Devices that are sold across the United States.
  • control of the work environment control the work environment to warrant the safety of the product.
  • concentrate on risk management and design control actions in the course of product development
  • specific requirements for traceability and inspection for implantable devices
  • specific specifications for documentation and verification of procedures for medical devices
  • specific requirements to verify the efficiency of preventive and corrective actions

Conformity to ISO 13485 is often seen as the first step to reaching the compliance of European regulations. It is the conformance of Medical Devices and In-vitro Diagnostic Medical Device like to EEC-decrees 93/42/EEC. 90/385/EEC. and 98/79/ must be checked before the selling is allowed. The most reliable method to demonstrate conformity is certification of the Quality Management System – Requirements to be used for regulatory purposes like ISO 9001 and/or ISO 13485 and ISO 14971 by a Notified Body. The outcome of a positive test is a certificate of conformity that allows the CE marking as well as the authorization to market medical devices within the European Union.

The standard adopted by CEN as EN ISO 13485:2003/AC:2007 has been harmonised with respect to European Medical Device Directives, 93/42/EEC and 90/385/EEC as well as 98/79/EC.