Auditing against the '94 edition, I would address a finding's description against the requirements of the organization (QP's, WI's, etc) and the ISO Element along with /4.9 c) citing failure to follow "reference standards/codes, quality plans and/or documented procedures." Writing up a finding against a clause or sub-clause was always thought more meaningful citing the 4.9 c) area. An organization has implemented , for instance, a well defined system; however, due to whatever reason, someone dropped the ball. It was a lot more easier to cite the 4.9 c) area especially when this happens on numerous occasions which might be able to provide evidence of a systemic problem within an organization.
The standard has a number of locations which specifies types of procedures, the availability of documents, and so on, just as did the '94 edition, nothing new here in that regard.
The closest point I can find to addressing this issue especially if it if either problematic or systemic would be under
4.1 c) "determine the criteria and methods needed to ensure that both the operation and control of these processes are effective".
6.2.2 d) "ensure that personnel are aware of the revelance and importance of their activities and how they contribute to the achievement of the quality objectives".
and possibly management committment if a serious condition exists attributable to a failure connected to either: 5.1.a); 5.3; 5.4.1.
Ijust would be a lot easier if requirements from circa '94 4.9.c) were still on the books. One thing for sure, the standard as it now exist requires a lot of thought on the part of auditors to ensure that there is enough information provided in the audit report, especially the final summary for the auditee to be able to have a complete understanding of theresults of the audit and the effectiveness of it's QMS.
Thanks all, I just was looking for the best approach to use.
