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Typical Quality System standards include more options than GMPs. One of many leaders was and has always been, ISO 9001 certification consultant. It seemed to be in 1987 as the solution to the many differing quality standards first tier OEMs (Original Equipment Manufacturers) were subjecting their clients to. Inside of the automotive industry alone had been upwards of eight to 10 different standards a company would end up being prepare with regard to. Once they were ready, they have to entertain a team of auditors for 2 to 5 days or perhaps more. That really arising from hand. I thought this was certainly a scenario that asked for community input the expertise of the International Organization for Standardization.