Innovation and ISO 9001:2015
Users debate inclusion of innovation in the upcoming revision
By John E. "Jack" West and Charles A. Cianfrani
Should innovation be included in ISO 9001:2015? This question has become pertinent to quality professionals because the recently distributed International Organization for Standardization Draft International Standard (ISO/DIS) 9001 includes this word and concept as a quality management system (QMS) requirement for the first time.
This inclusion has prompted considerable discussion and debate, especially in social media. The primary thrust of the chatter has been related to the appropriateness of inclusion of such a word and concept as a requirement.
On one side is the view that innovation cannot and absolutely should not be required. At the other extreme is the position that innovation must unconditionally be a component of any credible QMS because it is relevant to the sustainability of all organizations.
Before exploring this question and to ensure a common understanding, consider the ISO/DIS 9000 definition of innovation: a process resulting in a new or substantially changed object. The object for the purpose of innovation can be a management system, process, product, service or technology.
A word that has a different meaning but is frequently considered a synonym for innovation is invention, which is idea generation, the result being a device or process somebody has created after study and experimentation. Invention does not have an ISO/DIS 9000 definition.
It is also meaningful to distinguish between innovation and improvement. Improvement is defined in ISO/DIS 9000 as activity to enhance performance.
When considering the inclusion of innovation in ISO 9001:2015, we believe that it is important to make a distinction between innovation and invention, and equally important to distinguish between innovation actions and the process of innovation.
It is also important to understand the difference between processes that are intended to achieve innovation and those directed at improvement because these processes have different objectives.
These ideas are often interrelated and sometimes even conflicted or confused. Ideally, a need drives invention and can result in an innovation that improves the product, process and organizational performance.
Not all innovation results in real improvement, however. In fact, it is possible to create inventions that actually degrade performance. Here is where a formal system can be critical to ensuring the concepts are properly used to achieve improvements.
It is also possible that improvement, innovation and invention come together in a single project (see Figure 1).
Reasons for the chatter
Some of the concerns that have been raised regarding the inclusion of requirements for innovation include:
- Requirements in the DIS are vague and cannot be clearly stated.
- Innovation is a qualitative concept and cannot be audited.
- Innovation processes are beyond the scope of a QMS.
- Advocates of inclusion of requirements related to innovation have recognized current and anticipated trends organizations will need to address, including:
- Changing customer requirements.
- Increased competition.
- Continuing pressure to lower costs.
- How new technology can impact product design and realization.
- The impact of globalization on organizations.
- The fact that innovation is embedded in the content and intent of the quality management principles such as leadership, involvement of people and continual improvement, which are elements of ISO 9001’s foundation.
- The fact that innovation has always been an implicit ISO 9001 requirement that is now being formally recognized.
What should we do?
As of early 2015, it is not known whether
innovation requirements will be
explicitly included in ISO 9001:2015. Although it is likely the word innovation, mentioned only once in the current DIS, will be deleted, we believe any uncertainty is irrelevant.
This is because even if innovation is not an explicit requirement in the published edition of ISO 9001:2015, it is an essential process to incorporate into the QMS of all organizations for many reasons, including:
- When considering the context of the organization (see Figures 2 and 3), to ignore the role of innovation can be a significant deficiency.
- It is vital to define and deploy a QMS that will not only meet minimum ISO 9001:2015 requirements, but also will provide a foundation for achieving overall performance excellence (see Figure 4).
- Innovation processes must integrate with the overall risk management processes of the organization (see DIS clauses 4 and 6).
The major issue is that many quality professionals do not recognize the importance of incorporating processes that formally require attention to innovation as an organizational imperative. All too often we hear the formal system is an impediment to successful innovation. In fact, the formal system should be designed to foster innovative improvements.
Furthermore, as was true in the past for control of design and development, many quality professionals will fail to dedicate effort to the design and deployment of processes to formally consider innovation for products, services, processes, technology and systems because doing so is perceived as difficult, organizational resistance is anticipated or they think it will take too much time.
Innovation has become an organizational imperative. A few years ago, many of us did not understand what the word implied. Today, organizations need disciplined processes to facilitate the development of innovative products and services.
Invention is still important, but turning an idea into a product desired by customers constitutes real innovation and ensures the organization’s continued existence. Improving existing products and processes is critical, but improvement typically is focused only on advancing existing products or processes. Innovation processes focus on new or substantially changed products and processes.
Keeping quality at the forefront
If the quality function desires to remain relevant in a changing business environment, it is not sufficient to continue to use the same methods in the same way as in the past—even the recent past. New or enhanced skills may be required, including processes to manage innovation. Maintaining the status quo is not an option.
Even if innovation requirements do not remain as an ISO 9001:2015 requirement, processes to formally consider innovation for products, services, processes, technology and an overall QMS are essential to the sustainability of an organization.
Quality professionals should be asking questions such as:
- Do formal innovation processes exist?
- Do those processes encourage appropriate innovation?
- Do results indicate the processes are effective?
- Is there a process champion promoting the quest for innovative products and processes?
Innovation is an essential component of a QMS today and will continue to be, even if it is not an explicit requirement of ISO 9001:2015.
John E. "Jack" West is a member of Silver Fox Advisors in Houston. He is past chair of the U.S. Technical Advisory Group to the International Organization for Standardization Technical Committee 176 (ISO/TC 176) and lead delegate of the committee responsible for the ISO 9000 family of quality management system standards. He is an ASQ fellow and has co-authored several ASQ Quality Press books.
Charles A. Cianfrani is a principal consultant for Green Lane Quality Management Services in Green Lane, PA. An ASQ fellow, Cianfrani is a U.S. expert representative to ISO/TC 176. He has an MBA from Drexel University in Philadelphia and a master’s degree in applied statistics from Villanova University in Pennsylvania.