Chapter 7 of FDA CDRH’s division of small Manufacturers Assistance “Medical Device Quality Systems manual: A small entity Compliance Guide”. this manual was issued in December of 1996 shortly after release of the final version of the Quality System Regulation. It was intended to help explain the Quality System Regulation and how to comply with its requirements. Chapter 7 is titled “Equipment and Calibration “. Section 7-1 through 7-8 address software used in the production and quality system and has some interesting things to say about CNC equipment.