The International Organization for Standardization (ISO) technical committee TC176/TF has developed a “Future Concepts Final Draft” (1).  The purpose of the draft is to:

• Explore concept that can impact quality, quality management, or quality management systems.
• Provide guidance and recommendations to ISO/TC 176 committees, sub committees, working groups and task forces on future concepts.
• Provide an input for all groups revising current ISO/TC 176 documents.

The draft is getting some push back. For instance, Oxebridge Quality Resources, in a series of three articles entitled “You’re Going to Hate the Next Edition of ISO 9001,” criticizes the concepts. (2) The criticism is that there does not seem to be any attempt by TC 176/TF to realistically deal with why ISO 9001 certifications have been declining.

The final draft lists eight concepts. This piece looks at one of the concepts. That concept is Organizational Culture. It will discuss the concept, and the arguments for its inclusion in the revision of ISO 9001. It will also look at some of the implications for the quality profession.

ISO 9001 Purpose

To evaluate the concepts, it is worth stating the purpose of ISO 9001:2015. Section 0.3.1 under Process Approach states that the standard promotes “a process approach”, which is designed to improve the effectiveness of a quality management system.

ISO 9001:2015, therefore, establishes a standard against which an organization’s “quality management system” can be evaluated. The quality management system is the set of policies and processes related to quality management.

Section 0.2 Quality Management Principles provides the basic principles for quality management. These are:

1. Customer Focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making
7. Relationship Management

With these principles in mind, let us look at the concepts presented in the draft document to see how well they match with the principles.

Concepts

The task force lists eight concepts that it believes are important for ISO 9001’s future. These are:

1. Customer Experience
2. People Aspects.
3. Change Management.
4. Integration
5. Knowledge Management.
6. Emerging Technologies.
7. Ethics & Integrity.
8. Organizational Culture.

When the concepts are compared against the principles, except for Customer Experience, and People Aspects, there is no obvious one to one match.  Thus, the reader must dig deep to assess how each concept is to be integrated into ISO 9001. This is not an easy task because of the structure of the draft. The draft has essentially three components for each concept. These are: 1. a general definition, 2. An argument supporting the need to incorporate the concept and 3. How the concept will be incorporated. Often the supporting arguments fade, when it comes time for incorporation. This can be seen in the concept Organizational Culture.

Organizational Culture

Definition

Lines 939 and 940 of the draft provide a definition of Organizational Culture. “Organizational culture refers to the collective beliefs, values, attitudes, manners, customers, behaviors and artifacts unique to an organization.”

Argument

The favorable arguments are lengthy. Two aspects summarize the arguments. 1. “Organizational culture has a tremendous impact on quality, quality management and quality management system (QMS) practices and policies.” (Lines 956 and 957) 2. Organizational culture requirements are already included by inferences within ISO 9001 and excellence models. (The excellence models referenced are the 2019-2020 Baldrige Excellence Framework and the European Foundation Quality Management model.)

Additionally, organizational “culture is fundamental to an effective QMS to meet the needs of interested parties. Including organizational culture in the standard will encourage every organization to examine the organizational culture and the expectations of leadership in setting that culture.” (Lines133-135)

In sum, the culture of the organization has an impact on the quality, quality management and QMS policies and practices. Under the current standard, however, organizational culture is merely inferred. Thus, the task force believes there should be greater specificity.

How to Incorporate Concept into ISO 9001

The idea is to add “Organizational Culture” to Clause 4.1 Understanding the Organization and its Context and clause 5.1 Leadership. “There is a reference to culture under clause 4.1 under NOTE 3: Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge, and performance of the organization.” (Line 129, emphasis added)

It is unclear whether the intent is to just add “organizational” before culture, or to add another issue “organizational culture”. It is also unclear, how, despite the favorable arguments, the addition will substantively impact ISO 9001 viability. After all, “culture” is already included as an issue. The encompassing nature of the definition of “culture” can include organizational culture. Further, all organizations have an existing culture. While the immediate intent seems to just add the word organization, the ultimate intent may be to specify a culture.

Lines 1027 to 1030, when discussing organizational leadership, state: “It is not only the embodiment and content of organizational quality culture, but also has great influence on the cultivation of that culture when the leaders pay attention and work to live within and influence the quality culture through the awareness of quality culture cultivation and their own quality consciousness and leadership.”

This implies that the organization’s culture should be a “quality culture”. But what is a quality culture? How can it be measured? How do you square the desire for a quality culture with the mere inclusion of “organizational”?

This lack of clarity in purpose, the lack of awareness of the basic problems underlying ISO 9001’s decline, and the minimal impact on the underlying cause for decline, will create problems for the quality profession.

Implications

There are two adverse impacts the proposed concepts will have on the quality profession. These are the minimal impact on ISO 9001’s major problems and the further eroding of the ISO 9001 boundaries.

Minimal Impact

The first is the minimal impact on ISO 9001’s fundamental problems. It is hard to see how adding additional ornaments to the ISO 9001 Christmas tree will improve the condition of ISO 9001. The number of ISO 9001 certifications have been declining for years. One reason for the decline is that there are a lot of auditors chasing fewer and fewer 9001 audits.   As competition for audits has increased, the quality of the audits and thus the relevance, has declined. This downward spiral has resulted in fewer jobs for quality auditors. The loss of quality auditor jobs will be exasperated by what is being called Quality 4.0. This is the use of Artificial Intelligence to do 100% product inspections. Those doing inspections will find their jobs slowing being eliminated.

The quality profession is declining. Adding the concepts to ISO 9001 is not going to stop this decline.

Boundary Erosion

The second impact is that the more ISO 9001 is moved outside the narrow boundaries of a quality management system, the more diluted and less meaningful it becomes. In addition, as ISO 9001 becomes more diluted, the more outside actors will seek to do auditor work.

As long as 9001 was strictly focused on the quality management system and product quality, quality professionals could keep others out. When the narrow boundaries are breached, as in the case of Risk Based Thinking (RBT), other actors become involved.

Risk Based Thinking

RBT was added to ISO 9001:2015. The introduction to ISO 9001:2015 indicates the expansive nature of RBT. “Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise.”

RBT enables management to identify the risks associate with its “processes” and “quality management”. ISO 9001:2015 requires management to be concerned with all the risks it faces. RBT requires an enterprise wide approach to risk assessment.

The concept draft reinforces the expansive nature of RBT. “Risk based thinking is essential for achieving success to mitigate potential risk or prevent recurrence of a risk and may involve change at some level.” (Line361-362)

The administrative process used to implement RBT is called Enterprise Risk Management (ERM). ERM is the process used to evaluate all the risks an organization faces and then develop mitigative actions. The QMS is just one part of the entire organization. A poor-quality product is just one of many risks.

ERM is being pushed by Accountants and Auditors around the world. (The details of this effort are presented elsewhere. (3)) A key professional organization pushing ERM’s adoption is the Institute of Internal Auditors (IIA). It is encouraging members to help implement ERM.  IIA recognizes that its members are well positioned to conduct risk assessment audits.  It also knows that internal auditors have more influence with management, than do the quality auditors.

The internal auditor’s performance audits cover the gamut of organizational activities. The quality auditor’s focus is just the QMS. For the internal auditor, an audit of the Quality Management Systems is be just one more audit area.

Conclusion

With ISO 9001 certifications losing value, fewer organizations are obtaining the certification. It is difficult to see how the addition of the concepts will halt this decline in ISO 9001 certificaitons.  It is likely the addition of the concepts will further dilute ISO 9001’s focus.  Further dilution could speed up the decline in certifications. In short, the addition of the concepts to ISO 9001 may do more harm than good.

End Notes

1. ISO/TC 176/TF 4 N42, 2019, “Future Concepts Final Draft – 1^st Concepts”, December, https://www.oxebridge.com/downloeads/ISO9001futureconcepts.pdf.
2. Paris, Christopher, 2020, “You’re Going to Hate the Next Edition of ISO 9001”, https://www/oxebridge.com/emma
3. Kline, James J. and Greg Hutchins, 2019, “Auditors, Accountants and ERM”, Journal of Government Financial Management, Winter, pages 33-37.

BIO

James J. Kline is a Senior Member of ASQ, a Six Sigma Green Belt, a Manager of Quality/Organizational Excellence, and a Certified Enterprise Risk Manager.  He has work for federal, state, and local government. He has over ten year’s supervisory and managerial experience in both the public and private sector.  He has consulted on economic, quality and workforce development issues for state and local governments.  He has authored numerous articles on quality in government and risk analysis. His book “Enterprise Risk Management in Government: Implementing ISO 31000:2018” is available on Amazon.  He is the principle of JK Consulting. jeffreyk12011@live.com