ISO 13485

ISO 13485 is a Quality Management System standard for companies that produce medical devices.  The standard was first published by the International Organization for Standardization (ISO) in 1996.  The 13485 standard was based on the ISO 9001-1994 standard but with differences specific to the medical device regulatory environment.  In 2003, the standard changed again following the changes that occurred with ISO-9001:2000.  These changes included the process approach which restructured the standard into processes.  But for ISO 13485, the 2003 changes also included a focus on risk management further separating it from ISO 9001:2000.

The ISO 13485:2003 standard differs from ISO 9001-2008 in several ways including the following:  A focus on management promoting regulatory compliance, risk management methods required during development process, control of the work environment to ensure product safety, specific requirements for evaluating the effectiveness of corrective actions and specific requirements based on product use e.g. sterile products, implants, software, etc., have specific documentation, traceability, verification and/or validation requirements.

ISO 13485 registration demonstrates an organization’s commitment to regulatory compliance and managing their business processes in a controlled environment.  It also demonstrates to the regulatory community and customers a level of accomplishment and capability necessary to be successful in the medical device industry.  

Below are links and information related to ISO 13485 that may be useful to implementation and a better understanding of the standard.

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THE QUALITY MANAGEMENT RESOURCE

ISO 13485

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THE QUALITY MANAGEMENT RESOURCE

ISO 13485