Guidance approach (iso tc 176 sc..)

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Document: ISO/TC 176/SC 2/N 544R
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Secretariat of ISO/TC 176/SC 2 Date: 17 May 2001

ISO 9000 Introduction and Support Package:
Guidance on the Process Approach to quality management systems

In conjunction with the publication of the International Standards ISO 9001:2000 and
ISO 9004:2000, ISO/TC 176/SC 2 has published a number of guidance modules:

– Guidance on ISO 9001:2000 clause 1.2 'Application'
– Guidance on the Documentation requirements of ISO 9001:2000
– Guidance on the Process Approach to quality management systems
– Guidance on the Terminology used in ISO 9001:2000 and ISO 9004:2000 _1)

(1) This module was developed jointly with ISO/TC 176/SC1/WG2.
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ISO 9004:2000 guides the organization beyond the requirements of ISO 9001:2000 by focussing on performance improvements. ISO 9004:2000 recommends an evaluation of the efficiency, as well as the effectiveness of the processes.

Process effectiveness and efficiency can be assessed through internal or external review processes and be evaluated on a maturity scale. These scales typically range in degrees of maturity from “no formal system” to “best-in-class performance”. An advantage to this approach is that results can be documented and monitored over time to reach improvement goals. Numerous maturity tables have been developed for different applications. One such model is contained in ISO 9004:2000 Annex A, Guidelines for Self-Assessment.

3) The P-D-C-A Cycle and the process approach

The “Plan-Do-Check-Act” cycle was first developed in the 1920’s by Walter Shewhart, and was popularised later by W. Edwards Deming. For that reason it is often referred to as “The Deming Cycle”. Extensive literature exists about the PDCA cycle in numerous languages, and users of the ISO 9000:2000 family of standards are encouraged to consult this for a deeper understanding of the concept.

The PDCA concept is something that is present in all areas of our professional and personal lives, and is used continually, either formally of

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