9.4 Mandatory Effective Implementation Requirement

The requirement for effective implementation is expressed in Par. 4.1: General Requirements, in prescriptive form in Par. 8.4: Analysis of Data, and in more prescriptive terms in Par. 8.5.1: Continual Improvement.

This use of redundancy (previously classified as concomitance) offers a great deal of help to those who had trouble with the 1994 text in that it clearly defines the basis for metrics to establish QMS effectiveness. For example, its descriptive language on audits now encompasses all audit categories—conformance, compliance, system, process, product, internal, vendor, and customer. Additionally, design reviews and customer complaints are also necessary parameters upon which to base effectiveness—we need to also include these two categories into our analytical studies.