CHAPTER 2: THE ISO GUIDANCE DOCUMENTS
As part of the family of ISO 9000 documents, ISO 9004 provides guidelines to those organizations seeking to implement the requirements specified in ISO 9001.
ISO 9004 is mentioned only once within the ISO 9001 requirements and only in the introduction – something that is rarely considered by implementers. This is borne out by the numbers of the individual volumes sold by ISO – at one point ISO 9001 outsold ISO 9004 by a factor of 10:1!
Those who did obtain a copy of ISO 9004 may not have been entirely satisfied with their acquisition! Let’s briefly review the previous and current versions, since they are applicable to the ISO 9001 document that has remained substantially unchanged since the 2000 version.
ISO 9004:2018
This version of ISO 9004 is entitled “Quality management – Quality of an organization – Guidance to achieve sustained success.”
The introduction states:
“Introduction
This document provides guidance for organizations to achieve sustained success in a complex, demanding and ever-changing environment, with reference to the quality management principles described in ISO 9000:2015. Where they are applied collectively, quality management principles can provide a unifying basis for an organization’s values and strategies.
While ISO 9001:2015 focuses on providing confidence in an organization’s products and services, this document focuses on providing confidence in the organization’s ability to achieve sustained success.
Top management’s focus on the organization’s ability to meet the needs and expectations of customers and other relevant interested parties provides confidence in achieving sustained success. This document addresses the systematic improvement of the organization’s overall performance. It includes the planning, implementation, analysis, evaluation and improvement of an effective and efficient management system.
Factors affecting an organization’s success continually emerge, evolve, increase or diminish over the years, and adapting to these changes is important for sustained success. Examples include social responsibility, environmental and cultural factors, in addition to those that might have been previously considered, such as efficiency, quality and agility; taken together, these factors are part of the organization’s context.
The ability to achieve sustained success is enhanced by managers at all levels learning about and understanding the organization’s evolving context. Improvement and innovation also support sustained success.
This document promotes self-assessment and provides a self-assessment tool for reviewing the extent to which the organization has adopted the concepts in this document (see Annex A).”3
The guidance was published with the intention of being consistent with ISO 9001 – the term “consistent pair” being used to describe them both. The format of the ISO 9004 document was closely aligned to the ISO 9001 requirements so that cross-referencing was made easier.
ISO/TS 9002
ISO 9004 was never intended to be a how-to guide for those who were new to the concepts and practice of QMSs, which would be frustrating, especially when the title states “guidelines.”
It did, however, provide excellent descriptions for those who sought to improve the basics of the QMS they had constructed, in particular concerning internal audit planning.
3 www.iso.org/obp/ui/#iso:std:iso:9004:ed-4:v1:en.