1. Company A had received nonconformity about design
review
Company A got ISO9001 registration ten years ago. During the years the
same assessor had done surveillance assessment. Recently the assessor
had changed and a new assessor came.
The new assessor pointed out as a nonconformity that against requirements
of design reviews in ISO9001: 2000, the company did not do design reviews
before design verification.
The management representative of the company made an objection to the
nonconformity saying that the Standard requires design reviews shall
be done at gsuitable stagesh, therefore there was no requirement a fixed
sequence about design reviews.
But the assessor strongly asserted his nonconformity. Finally the management
representative could not help admitting the nonconformity.
2. Two problems on the nonconformity
The one is a false understanding of gsuitable stagesh by the assessor.
The meaning of gsuitable stagesh explained by a diagram in gISO9000
for Small Businesses: Advice from ISO/TC176h, shown below.
Simplified diagram of the relationship
between design review,
design verification and design validation
I insert letters of A, B, C and D in the diagram for explaining
following passages clearly.
According to the diagram, the meaning of gsuitable stagesh is that
you can select stages from A, B, C and D, corresponding to your product
nature, the processes employed and the size and structure of your
company. The assessor insisted on the uniformity of C. It is a false
understanding of gsuitable stagesh.
The other problem was that it is not a fair assessment for the certification
body because the nonconformity was different by assessors.@The assessment
criteria are unstable for such an important matter.
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