[Amps] FW: Power factor correction on tube amps

[Roger (K8RI)]

On 3/10/2013 12:01 PM, Ward Silver wrote:
> 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.

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 detailed, 
rigid, and contains penalties for non conformance compared to ISO

As I said earlier, ISO can be an effective tool when properly 
implemented and understood, but in the case of medical devices, I'd 
expect FDA validation to be far more effective and restrictive.

73

Roger (K8RI)

  ISO-9xxx is not
> appropriate for most manufacturing but if your life hangs in the
> balance, you had better hope and pray that the manufacturers of whatever
> instrument is about to help you see another day take their process
> seriously.  People expressing the attitude that ISO-9xxx had "no benefit
> at all" were vigorously encouraged to find another line of work and
> quickly.  When the product use environment is both complex and
> high-risk, design and production processes are absolutely critical.
>
> 73, Ward N0AX
>
>> >ISO docs mainly describe the work process and record keeping in detail,
>> >but not the product itself.
>> REPLY:
>> Exactly why it's a waste of time. Nobody cares about the "work process".
>> They care about the product.
>>
>> A company can be in full compliance and still turn out junk.
>> Carefully documented junk.
>>
>> ISO 9xxx is a perfect example of bureaucratic meddling with no benefit at
>> all.
>>
>> Wise up, people.
>>
>> 73, Bill W6WRT
>
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