Quality Culture and Ethical Behaviour: Requirements in ISO 9001:2026 QMS

Quality Culture and Ethical Behaviour: Requirements in ISO 9001:2026 QMS

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While reading the newly published standard ISO 9001:2026, I observed that the phrase “quality culture and ethical behaviour” is used several times. Let us examine its significance and implications for the requirements of a Quality Management System (QMS).

1. References in ISO 9001:2026

Foreword

The Foreword identifies the introduction of quality culture and ethical behaviour as one of the main changes in the revised standard. It explains that these aspects are now addressed within the requirements, particularly in relation to leadership, awareness and the environment for the operation of processes.

Clause 5.1.1 — Leadership and commitment

Subclause 5.1.1 (i) requires top management to demonstrate leadership and commitment with respect to the QMS by promoting quality culture and ethical behaviour.

Note 2 at the end of this clause clarifies that an organization's quality culture and ethical behaviour are reflected in its shared values, attitudes, practices and actions.

Clause 7.1.4 — Environment for the operation of processes

This clause requires the organization to determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.

The accompanying note explains that a suitable environment may involve a combination of human and physical factors. It further clarifies that some of these factors can be influenced by the organization's quality culture and ethical behaviour.

Clause 7.3 — Awareness

Subclause 7.3 (e) requires the organization to ensure that persons doing work under its control are aware of the organization's quality culture and ethical behaviour.

Annex A — Guidance on the requirements

The phrase “quality culture and ethical behaviour” also appears several times in Annex A. However, Annex A is informative and provides guidance for understanding the requirements; it does not introduce additional requirements for the QMS.

2. Implications from an auditing perspective

If we examine these provisions from an audit perspective, two explicit requirements deserve particular attention:

1. Leadership: Has top management demonstrated its commitment to promoting quality culture and ethical behaviour within the organization?

2. Awareness: Are persons doing work under the organization's control aware of its quality culture and ethical behaviour?

Auditors may seek objective evidence to establish whether these requirements have been addressed effectively. Such evidence could include management decisions, communication, awareness activities, workplace practices and the behaviour demonstrated by organizational leaders and personnel.

The auditor should not merely verify whether a policy or statement exists. The focus should be on how the organization promotes quality culture and ethical behaviour and whether relevant personnel are aware of them.

Furthermore, Clause 7.1.4 provides an additional connection between organizational culture, ethical behaviour and the environment in which processes operate. Therefore, the audit should not be restricted to leadership and awareness alone.

3. Is there a gap in Clause 9 — Performance evaluation?

One aspect that deserves consideration is the absence of an explicit requirement in Clause 9 to monitor, measure or evaluate the effectiveness of quality culture and ethical behaviour.

Clause 9 addresses performance evaluation through monitoring, measurement, analysis, evaluation, internal audits and management reviews. However, it does not specifically require organizations to evaluate the effectiveness of their efforts to promote quality culture and ethical behaviour.

This raises an important question: How can an organization determine whether its efforts to promote quality culture and ethical behaviour are effective if the standard does not explicitly require their effectiveness to be evaluated?

For example, an organization may conduct awareness programmes and communicate its expectations regarding ethical behaviour. However, the completion of these activities alone does not necessarily demonstrate that the intended culture has been established or that ethical behaviour is consistently practised. 

A more explicit requirement to evaluate the effectiveness of quality culture and ethical behaviour could have strengthened the standard by encouraging an organization to assess whether its initiatives are achieving the intended results.

4. Conclusion

ISO 9001:2026 gives greater prominence to quality culture and ethical behaviour by explicitly addressing them in the requirements relating to leadership, awareness and the environment for the operation of processes. Nevertheless, the absence of an explicit requirement in Clause 9 to evaluate their effectiveness may be considered a limitation.

In my view, promoting quality culture and ethical behaviour is important, but evaluating whether these efforts are effective is equally significant. Such evaluation could help organizations identify gaps, take appropriate action and strengthen their QMS. 

What is your opinion? Should ISO 9001 explicitly require organizations to evaluate the effectiveness of their quality culture and ethical behaviour as part of performance evaluation?

Regards,

Keshav Ram Singhal