|
No. |
Item |
Assessor’scomment |
Complaints by Company T |
Correction |
|
1 |
Purpose of quality manual (QM) |
Should include1.1 a)b) of the Standards in QM. |
1.1 explains the purpose of the Standards. No relation with
the purpose of our QM. |
No correction |
|
2 |
5.6.3 |
Words of a) b) c) of 5.6.3 clause are not written in QM. |
No requirement to write sentences as in the Standards in QM.
Please audit at our site, not by the document audit. |
No correction |
|
3 |
7.2 |
No documented procedures about 7.2.1 clause. |
No “ documented procedure” required, but QM describes
outlines. Please audit at our site, not by the document audit. |
No correction |
|
4 |
7.3 |
No documented procedures about 7.3 clause |
No correction |
|
5 |
7.3.6 |
QM says the customers’ acceptances of design output are evidences
of validation, but this is not acceptable. |
We have certification of ISO9001: 1994 by your body. The requirements
are not changed. It is irrational that the criteria of audit
changes by an assessor. |
No correction |
|
6 |
7.5.1 |
No documented procedures about7.5.1 clause. |
No “ documented procedure” required, but QM describes outlines.
Please audit at our site, not by the document audit |
No correction |