The Quality System Regulation (QSR) 21 CFR Part 820, aka FDA current Good Manufacturing Practices (cGMP) for Medical Devices, is what regulatory professionals should be referencing in their quality system procedures. Part 820 embodies all the major parts of the FDA quality system that are shared with ISO 13485:2016—“Medical devices—Quality management systems—Requirements for regulatory purposes.” In fact, according to the QSR’s preamble, Part 820 was originally crafted to align with ISO 9001:1994 and ISO 13485:1996.

The FDA has said that ISO 13485 covers about 90 percent or more of its QSR. How nice, but what about the other 10 percent? Many manufacturers are surprised when an FDA investigator asks questions about other “Parts” in the Federal Regulation that don’t align with ISO 13485, and yet are considered some of the most critical points of concern during an FDA inspection.

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