29. May 2018

The new ISO 9004:2018

In April 2018, the revised version of ISO 9004:2018 has been published. The following article deals with facets of the Standard’s history, as well as with objectives of the revision and significant changes.

Why is there an ISO 9004?

ISO 9004 was originally designed in 1994 as a Guideline for the application of ISO 9001. In the year 2000, the requirements were expanded: The Standard was developed together with ISO 9001 as a consistent pair. It contained further requirements and – for the first time – an instruction for self-assessment. However, ISO 9001 was still included as the main body of the Standard.

In 2009, the interconnection to ISO 9001 was lifted – the 2009 version was developed as an independent Standard to guide an organization towards improved performance and had a bridging function to business excellence models (Malcom Baldrige Award, EFQM Model etc.).

This bridging function remains the same in the 2018 version of ISO 9004. The current version intends to provide Guidance to achieve sustained business success, which is equated with the concept of „Quality of an organization“.

Figure 1, Source: Nigel Croft, Proceedings of the "61st EOQ Quality Congress" in Bled, Slovenia, October 2017

What is meant by „Quality of an organization“?

Even if this is only a „small change” in the title – it still sends a clear message: The quality of an organization is equated with its ability to achieve sustained success.

Sustained success in a complex, demanding and ever-changing environment is not to be taken for granted. For example, the 2018 Corporate Longevity Forecast predicted that by 2027, organizations represented in the Standard & Poor’s 500 would be listed in this index for an average of 12 years. The S&P 500 includes stocks of the largest companies with market capitalization of more than six billion dollar. New technologies, economic shocks, disruptive competitors and eventually the inability to identify and address future challenges are the main reasons for conditional sustainability.
Obviously, there is a need for guidance to achieve „sustained success“. However, ISO 9004:2018 is not only applicable to large enterprises but to any organization, regardless of its type and size.


Objectives of the revision, procedure and previous findings

What were the objectives of revision? The revision of the Standard by ISO TC 176 SC2 Quality Systems WG 25 was carried out after successful ballot in May 2015, based on a „Design Specification for the Revision of ISO 9004“ of September 2015. Prior to the revision decision, a study had revealed that publicity of the Standard and awareness of the possible benefits of ISO 9004:2009 (as with the previous version) are quite limited.

Based on the results from surveys initiated by ISO TC 176: What do users except from the revised version of ISO 9004?
The Standard should be written in plain language and in user-friendly format, while taking into account the changing requirements of organizations in achieving sustained success. Furthermore, emphasis should be placed on the needs and expectations of interested parties so that an organization will gain competitive advantages. ISO 9004 should help to improve an organization’s management system, ensure the coherency of the organization’s vision, mission, values and culture and consider the management of risks and opportunities. In addition, the innovations, concepts, terms and definitions given in ISO 9000 and 9001:2015 should be incorporated.

The Standard should remain generic and applicable to all types of organizations. The ultimate goal of the revised ISO 9004:2018 is to provide a Guide that will help to achieve sustained business success with strategic and operational management.


Content and Changes

The graphic illustrates the „philosophy” and major changes of ISO 9004 best (Figure 2). We want to focus on some of the points (green exclamation marks) in particular:

Figure 2, Source: acc. to Draft DIN EN ISO 9004:2018, modified by the auditors

First, one notices that ISO 9001 is not represented in this graphic. Here, it might be symbolic, but this is reflected throughout the Standard - ISO 9004 no longer wants to be considered an „add-on standard“ to ISO 9001 but independent, while addressing managers at all levels, particularly those in leading positions. Accordingly, all interested parties are equally taken into account.

Again, this concept is illustrated in a graph in the Standard:

Figure 3, Source: acc. to the Draft DIN EN ISO 9004:2018

The Clause „Identity of the organization” is conceptually new. While ISO 9004:2009 has only touched on the subject of “vision” and “mission”, the 2018 version enlarges upon these topics, and complements them with “identity” and “culture”. This is based on the background that organizations are sometimes not able to reconcile their identity and culture in case of necessary changes, which inevitably causes failure: therefore, this Clause is particularly important for achieving sustained success in a complex and ever-changing environment.

The title „Leadership” is new in ISO 9004:2018, although individual elements such as objectives, policy and strategy were already addressed in the 2009 version.
Further new topics are: "to create an environment in which people are engaged” and „to ensure that leaders at all levels establish and maintain the unity of purpose and direction”. The topic “strategy” is substantially extended as well. In addition to „the purpose of strategy” – as it was focused on in the 2009 version – now the Standard contains various recommendations on how to „develop the strategy and what should be considered when establishing strategy”.

In Clause 11 “learning organization”, the approaches of “learning as an individual”, “knowledge of the organization” and “values” are interlinked. Unfortunately, there was hardly any development of the section “Innovation”. There is still potential for improvement with regard to sustainability of organizations.


What are the benefits of the new ISO 9004?

The revision resulted in a successful new version of ISO 9004, which has been detached from ISO 9001 and which provides a comprehensive and complete consideration of successful business management. Therefore, the Standard is well-suited as a Guide for Managers.

However, the Standard also serves a second purpose: Most of the requirements of ISO 9001 are formulated in a concise way and are clearly focused on “the quality of products and services”. When implementing these requirements, some questions still arise: „What is the use of it” and “What are the benefits for our company?”

ISO 9004 uses a similar language and embeds the topics of ISO 9001 in the context of sustained success. Thus, the Standard has accomplished a goal that was not intended when first developing the Standard: It now provides excellent guidance on how to manage the requirements of ISO 9001 and complements them, so that organizations’ can achieve sustained success.



Thomas Votsmeier
Head of the International Cooperation/Standardization,

Anni Koubek and Thomas Votsmeier are both members of the ISO TC 176 SC2 Quality Systems WG 25.

Author and Contact Person Quality


Ms. Dr. Anni Koubek

Executive Vice President Innovation, Business Development Certification Quality

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