Change: New Requirements
Procedure Required: NO
Record(s) Required: Inspection and/or Test Records
Comments:
This section requires the organization to monitor and measure the
characteristics of the product to verify that product requirements have
been met at appropriate stages of the product realization process in
accordance with the planned arrangements (see 7.1).
Evidence of conformity with the acceptance criteria must be maintained. Records must indicate the person(s) authorizing release of product. Product release and service delivery must not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.
I find it interesting that even though ISO 9001:2000 never specifically requires the acceptance criteria to be documented (ref. 7.3.3), evidence (i.e., a record) of conformity with the acceptance criteria must be maintained identifying the specific individual(s) who authorized release of the product!
Guidance:
I suggest paraphrasing the wording of the standard in your Quality
Manual AND identifying those stages in the process where product is
measured (i.e., inspected and/or tested) in the process flow chart
(developed to address section 7.1).
Be prepared to discuss the criteria for inspection and/or testing
activities with your ISO 9000 auditor.
Develop a method for creating records of final inspection and/or test which identify the specific individual(s) who authorized release of the product.
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Copyright © 2003 by Richard C. Randall This Page Last Revised: |
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