Quality Digest Article Clarification

Isaac Sheps clarification - As co-convenor of the ISO/TC176 Working Group that prepared the current version of ISO 9004, published in April 2018, I was initially happy to read Mr. Eliot Dratch’s paper “How to Use ISO 9004 to Improve Your Manufacturing Operation”, published in QD on 22nd Sep. 2021. The use of ISO 9004 in any type of organization is very welcome. 

Having said that, I can’t leave this paper without comments as there are profound concerns that it is misleading the readers in their understanding of ISO 9004 and how it differs from ISO 9001. 

In particular, I need to correct the gross misconception expressed in the paper related to the scopes of ISO 9001 and ISO 9004, where it is stated that “Each standard specifies requirements for a quality management system (QMS) when an organization needs to demonstrate its ability to consistently provide products and services that meet customer expectations in addition to applicable statutory or regulatory requirements. ISO 9001 improves manufacturing quality management systems by requiring detailed processes and implementing gap analysis and internal audits, whereas ISO 9004 entails a self-assessment component.”

This is correct for ISO 9001 as it copies clause 1 a) of ISO 9001 scope, but it is definitely not the scope of ISO 9004 which (according to its clause 1) is to provide “guidelines for enhancing an organization’s ability to achieve sustained success”.

This difference in scope is key to understanding the respective focus of the two standards:

1. Although most organizations derive significant benefits by implementing an ISO 9001-based system (in terms of productivity, communications, breaking down interdepartmental barriers etc), the core objective of ISO 9001 is (and always has been) to provide confidence in the organization’s products and services.
2. The focus of ISO 9004 is to provide confidence in the organization itself, and its ability to be successful in the long term. This involves many factors other than just “providing conforming products and services”! This is emphasized in clause 4 of ISO 9004, which clearly states that: “The organization should go beyond the quality of its products and services and the needs and expectations of its customers. To achieve sustained success, the organization should focus on anticipating and meeting the needs and expectations of its interested parties with the intent of enhancing their satisfaction and overall experience”. (Examples of various interested parties and their needs and expectations are presented in Figure 2 of ISO 9004).

This conceptual difference between ‘Product/Service Quality’ and ‘Quality of an Organization’ is also illustrated by the difference in the inputs and outputs of ISO 9001 Figure 2 and ISO 9004 Figure 1 that represent the structure of each document respectively.

Last but not least, the tailorable 5-level Process Maturity self-assessment annex in ISO 9004 is aimed at helping organizations to diagnose their strengths and weaknesses, to be used as a basis for improvement activities.

Because ISO 9004 is a guideline (not a requirements) standard, “yes/no” conformity assessment such as that applied for ISO 9001 is not appropriate. To paraphrase Deming “you don’t have to do any of this – Survival is not compulsory!”.