In 1996, ISO published " ISO9000 for Small Businesses: What to
do: Advice from ISO/TC176". The book has been a very good guide
book for small businesses to install efficient ISO9000 systems.
It has given many ideas to generate alternatives for achieving ISO9000
requirements. Thus the book has been useful for a company to avoid
uniformity in the structure of quality management system or uniformity
of documentation. Therefore even for a large business, it has been
a very good guide.
ISO9001: 2000 has come and the new version of the book had been
anticipated.
In 2002, ISO published the new version of the book, which was reviewed
in accordance with ISO9001: 2000.
I will give some comments for the book.
- [5.5.2 Management representative]
The new book gives more comments than the old version on this item.
I summarized them into following three items.
| (１) |
The responsibility and authority cannot be
assigned to someone outside the organization. |
| (２) |
It may be appropriate for the owner/manager
to assume the role for small businesses. |
| (３) |
Only one person can have overall responsibility
and authority on behalf of the organization, even it has a
several local management representatives. |
- [7.5.2 Special process]
The words of special process disappeared in ISO9001: 2000. Instead,
processes where the resulting output cannot be verified by subsequent
monitoring or measurement are required special cares in 7.5.2 clause.
The book takes up two examples. The one is the pouring of a concrete
slab. The other is welding. But the both can be verified by subsequent
measurement if "subsequent" does not means "immediately".
In NOTE 3 of 3.4.1 [process] of ISO9000: 2000, it says that process
where the conformity of the resulting product cannot be readily
or economically verified is frequently referred to as a " special
process".
Therefore, there are the following three different definitions.
It is confusing!
| (１) |
Cannot verified by subsequent measurement |
| (２) |
Cannot measure immediately |
| (３) |
Cannot be readily or economically
verified |
If sampling inspections are economically done because the processes
are stable the processes become special processes according to
(3). Then all processes of mass production will be special processes.
Therefore, QS9000: 2000 (ISO/TS16949: the second edition) says
that special processes shall apply to all processes for production
and service provision. The problem still remains unsolved.
- [8.5.2, 8.5.3 Corrective and Preventive action]
In f) clause of 8.5.2, it requires reviewing corrective action taken.
JIS adds special NOTE saying that this clause requires reviewing
a) to e). JIS also adds the same NOTE for 8.5.3.
But the book explains clearly as for corrective actins that you
should follow up the actions to find out whether they have been
effective. As for preventive actions the same thing is explained
for reviewing as following up the actions to find out whether they
have been effective.
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