ISO 13485 defines the requirements for a comprehensive quality management system for an organization who demonstrates ability to provide medical devices & related services.  When you are certified, your customers & supply chain know your business takes quality & regulatory affairs very seriously.

Like many other standards, this 13485 stems out of the ISO 9001 standard so there are many similarities as well as differences between them. Unlike the ISO 9001 standard, this one is heavily structured and requires many documents to be written in order to help your organization meet or even exceed customer & regulatory requirements. This ISO 13485 version is pushing the QMS to focus on managing risk throughout the whole quality system not only through the Corrective action & design process.

It pushes organizations to control their suppliers to have proper traceability procedures, understand risk at each process level as well as in a strategic level and ensure complaint handling & communication systems are clearly defined in order to mitigate risk. Not that they did not require some of this information before, but it is clear now that risk needs to be addressed at every level.

Bottom line, is that ISO 13485 focused in process effectiveness but also provides a commitment to the industry standards of safety & quality as well as regulatory compliance. As a matter of fact, United states FDA (Food and Drug administration) plans to use ISO 13485 for medical device regulation. You can read more about these plans here.

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