I have worked with ISO 9001 quality systems since 1997.
That matters, because I am not an ISO skeptic.
Quite the opposite.
I have worked through ISO 9001:1994, 2000, 2008 and 2015, and for most of that time I watched the standard get better.
The 1994 version was cumbersome and documentation-heavy. Too much energy could be spent proving that you had documented a process rather than determining whether the process actually worked.
ISO 9001:2000 was a major improvement. It pushed organizations toward the process approach. The 2008 revision refined that framework. Then 2015 incorporated risk-based thinking throughout the system rather than treating preventive action as a separate exercise.
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