Change: None
Procedure Required: YES
Record(s) Required: NONE
Comments:
This section clearly specifies the requirements for document control
(essentially the same as required in ISO 9001:1994).
CAUTION - Phantom Requirement:
Many ISO 9000 Auditors and Registrars interpret section 4.2.3b as
requiring organizations to schedule a periodic review of
documents. However, the standard does NOT specifically require a
periodic review. The standard states that the organization must
"review and update as necessary and re-approve
documents".
The simplest way to address this phantom requirement is to
include a review of all documents during the internal audit process and
report this in the management review meeting minutes.
Guidance:
I suggest:
a) stating the quality policy and quality objectives in the Quality Manual (ref. sections 5.3 & 5.4.1 for more detail)
b) that your quality manual paraphrase each section of ISO 9001:2000 (ref. section 4.2.2 for more detail)
c) creating documented procedures as required by section 4.2c
d) creating documented procedures for ALL of the applicable elements contained in section 7
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Copyright © 2003 by Richard C. Randall This Page Last Revised: |
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