While good in intention, the practical value of ISO and QS stuff is to provide the equivalent of an ongoing annuity to companies that perform the conformance audits. So it should be no surprise that
all.< I wouldn't say that, Bill. Just think of the money spent on air fares, hotels, meals and so-on (CIA, Secret Service and FBI can be more specific on what the so-on can include!) for the people w
Having worked on the design, development, verification, and validation of life-critical medical devices (cardiac defibrillators), I can categorically state that process matters. A lot. ISO-9xxx is no
IOW ISO provides a paper trail for lawyers....nothing else if a company is already highly credible. Carl KM1H Having worked on the design, development, verification, and validation of life-critical m
This confuses me a bit. Any medical device, including computer systems used for testing and data collection, plus equipment in the network is rigidly controlled by FDA "validation" which is far more
Any manufacturer who does not think there is already a paper trail for lawyers will get an expensive lesson, sooner or later. In this hyper-accountable world, process is often over-applied and over-r
REPLY: People who believe that ISO-9xxx will make a silk purse out of a sow's ear are highly encouraged to avoid making any life-critical equipment. I'll say it again: The best assurance of quality p
"Think of all the ways you can hurt yourself laughing." Yes and No. ISO won't make a silk purse out of a sow's ear. ISO forces the company to have written procedures that are current and are applied.
REPLY: Too bad Mr Stradivarius didn't have ISO-9xxx to guide him. He might have made a halfway decent product. 73, Bill W6WRT _______________________________________________ Amps mailing list Amps@co
Maybe in a way he did. After he perfected his instrument. How many failures do you think he had before he found the secret? Then he had the formula in his head or maybe in his notes. Someone came alo