Notes:

There is little or no provision in Mil-Q-9858A for:

A.Document Control

B.Product Traceability

C.Calibration & Status of Inspection and Test Equipment

D.Internal Quality Audits

E.Training

F.Servicing

It should be noted that contracts for military products

almost always carry requirements for these, however

this is done by citing additional specifications in the contract.

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NSC = Not Specifically Covered In Q91 (1987) NOTES: Mil-I-45208A Contains Fewer Requirements Than Mil-Q-9858A

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NOTES: 1.In general, the FDA GMP regulations are much more detailed than Q91 (1987). However, Q91 is much broader in defining the Quality System. 2.The requirements for Critical Devices are extremely detailed. 3.The GMP's do not speak to the following paragraphs: 4.3 - Contract Review 4.4 - Design 4.7 - Purchaser Supplied Product 4.12 - Inspection and Test Status 4.19 - Servicing Marc T. Smith

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