Change: Re-wording
Procedure Required: NO
Record(s) Required: NONE
Comments:
This section requires the organization to plan and carry out production
and service provision under controlled conditions. Controlled
conditions must include, as applicable:
a) the availability of information that describes the characteristics of the product,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement, and
f) the implementation of release, delivery and post-delivery activities.
On the surface this section appears to define "controlled conditions". However, upon closer examination one will see that the requirements for "controlled conditions" hinge upon the words "as applicable". This section requires no documented procedure(s) or record(s); nor do any of the sections relating to the criteria for "controlled conditions". Ultimately, the users may pick and choose which, if any, of the requirements they wish to address.
Guidance:
I suggest paraphrasing the wording of the standard in your Quality
Manual and addressing each of the criteria for "controlled conditions"
in the process flow chart (developed to address section 7.1). Be prepared to discuss the criteria
for controlled conditions with your ISO 9000 auditor.
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Copyright © 2003 by Richard C. Randall This Page Last Revised: |
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