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1. The meaning of "NOTE" in 4.1 General of ISO9001: 2000
The note says that processes needed for the quality management system
should include processes for management activities, provision of resources,
product realization and measurement. Then there are following four
elements in this sentence.
a) Management activities
b) Provision of resources
c) Product realization
d) Measurement
About a), management activities are activities of a quality management
system as its name indicates. It is like saying that the circulation
system of the blood needs circulate activities. It speaks for itself.
The explanation of the note is unnecessary.
About b), provision of resources is an activity to support efficient
product realization activities. Therefore it is one of management
activities. I wonder why TC176 includes this activity in a). No need
to separate and make independent from a). Only the confusion remains.
About c), product realization is not management activities and to
make product realization process efficiently management activities
may necessary. Quality management activities done by its system are
complementary to product realization system. Therefore, inclusion
of product realization in the sentence is the origin of confusion
of quality management processes with product realization processes.
Product realization can be done without management activities with
sacrifices of bad quality, delay of deliveries and high production
cost.
About d), measurement is also one of management activities, and it
is one step for analysis and improvement. But activities of analysis
and improvement are lacking in the Note.
2. The sentence in NOTE1 of 3.7.5 in ISO9000: 2000
With the awareness of the above issue, when I read 3.7.5 "quality
plan" in ISO9000: 2000, I noticed the following sentence in NOTE1.
" These procedures generally include those referring to quality
management processes and to product realization processes"
This sentence clearly separates the both. The both are in complementary
relation as ISO9001: 2000 referred to 0.1
If a company has not design and development processes, then there
is no need to complementary management processes. Then the company
will declare exclusion of 7.3 clause: Design and development in its
quality manual. But precisely it is not exclusion of design and development,
but control of design and development.
The word of " control" has disappeared in 2000 version from 1994 version.
The disappearance indicates symbolically the confusion of management
processes with product realization processes in ISO9001: 2000.
The title of 7. should be "Product realization management" or "Product
realization control", not the present "Product realization".
I don't know why excellent members of TC176 have made such basic mistakes.
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