Change: ADDITIONAL Requirements
Procedure Required: NO
Record(s) Required: NONE
Comments:
This section requires the organization to "determine and manage the
work environment needed to achieve conformity to product requirements".
However, no procedure or record is required to reflect this that this
ever happens!
Guidance:
I suggest paraphrasing the wording of the standard in your Quality
Manual. An ISO 9000 Auditor will seek out areas where the work
environment should be managed and attempt to determine whether the
organization is adequately managing that work environment. A common
example of managing the work environment to achieve and maintain
"conformity to product requirements" in an electronics manufacturing
facility could include ESD precautions.
CAUTION - Phantom Requirement:
Even though ISO 9001:2000, section 6.4 is clearly limited to managing
the work environment to the extent that it effects the organization's
ability "to achieve conformity to product requirements", some ISO
9001:2000 auditors are incorrectly using ISO 9004:2000 as
a guide to interpreting ISO 9001:2000. Among other things, ISO
9004:2000, section 6.4 states: "Management should ensure that
the work environment has a positive influence on motivation,
satisfaction and performance of people in order to enhance the
performance of the organization."
As mentioned in the Introduction, the last paragraph of ISO 9004:2000, section 1.0, "Scope" clearly states: "This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001."
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Copyright © 2003 by Richard C. Randall This Page Last Revised: |
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