Sec. 820.5 Quality system.

Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.

Interpretation:

It’s needless to say that the quality system regulation is a “quality system”.  There are other systems that have been adopted such as ISO 9000 that have additional requirements spelled out such as ISO 13485.  Although the FDA has plans to adopted a universal system along with the Global Harmonization Task Force, it currently expects an organization to follow and demonstrate compliance to the QSR. 

In some cases however, along with the QSR there are systems that can be applied to improve the overall quality of a product. For instance medical devices that consist of, or that contain software, can be developed using particular systems designed for software output.  Note that the FDA still requires an organization to demonstrate they are following the QSR.  Some organizations have developed their quality manual with references for the QSR along with other quality systems (such as ISO).  It can be useful (such as in FDA audits) to include in the table of contents the application of the QSR (and other quality systems) as they pertain to topics in their quality manual.  This is especially important in quickly demonstrating compliance to the QSR.

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Reference: www.FDA.gov

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