Whereto After ISO 9001:2015?

Moving beyond quality management to innovation management

by Peter Merrill

September 2018 is coming fast, and those who have not transitioned yet to ISO 9001:2015 are probably in a last-minute panic. Unfortunately, a number of auditors have given the false impression that the new ISO 9001 standard does not require any new work and transition is quite straightforward.

That is far from true.

To get real value from the new standard, you must link it to your business strategy, as well as the external and internal issues that create the context of the organization. The attendant risks are prioritized, and a plan containing measurable objectives is developed to mitigate those risks.

That is, of course, only the beginning.

IMS standard

Interestingly, these are also the first steps in an innovation strategy, and the ISO Innovation Management System (IMS) standard goes much deeper into innovation strategy in Clause 5—Leadership.

For those organizations that have already transitioned to ISO 9001:2015 and have found the true value of the new standard, there’s good news: The new ISO 50501 Innovation Management is due for publication at the end of this year, and its structure will fit perfectly with ISO 9001.

So here is your opportunity to integrate innovation into your business. The plan-do-check-act (PDCA) structure diagram for the IMS is shown in Figure 1.


Clause 4—Context

Starting with Clause 4—Context, you probably conducted a quality management system (QMS) strengths, weaknesses, opportunities and threats (SWOT) analysis for ISO 9001, and you probably focused on the weaknesses and threats to identify risks in your ISO 9001 QMS.

I’ve heard some people say that they didn’t know why the standard mentioned opportunities in Clause 6—Planning. Well, here’s why: The opportunities—and also the threats—give you drivers for innovation. See Figure 2.


Clause 4.2—Interested parties gets you asking who will be your potential customers for future innovative offerings. This, of course, relates closely to opportunities.

These strategic challenges—especially the marketplace challenges—give you the fuel for your innovation engine. Which of your products are declining? Which of your customers are going quiet? Build your list of threats and opportunities in preparation for clause 6, which—in the innovation standard—we will reverse the title to call it "opportunity and risk."

Good businesses look for opportunity first, and then calculate the associated risk.

Clause 5—Leadership        

Before moving to clause 6, however, clause 5 addresses leadership. I’m so glad that the term "management responsibility" is gone and now replaced with the language of business. The innovation principles in ISO 50501 address the need for leaders who are courageous and look to the future. Leaders will certainly be responsible for developing a culture of innovation. (More on culture in clause 7.)

You also will want to build innovation into your policy statement in clause 5.3, and the leadership clause devotes a full subclause 5.4 to innovation strategy.

Clause 5.5 addresses structure, and don’t overlook Clause 5.6—Roles and responsibilities, which is often skipped through and considered a "given" in ISO 9001.

Here, you must pause and ask yourself how you will structure innovation into your organization. If this is something new for you, you will certainly need a core team of change agents.

Clause 6—Planning

This is where you start to build traction and where you initiate your innovation portfolio. The portfolio will get much closer attention in clause 8. The output from clause 6 will be the innovation plan in which you identify whether you will be addressing product, process or business model innovations.

Clause 7—Support

Clause 7—Support is exactly that. It gives you everything you need to enable innovation. Innovation culture is the No. 1 topic I’m most frequently asked about. People want to know how to develop a creative culture that can co-exist with the execution culture of quality management.

For instance, they want to know how to allow exploration, collaboration and experimentation to thrive. And interestingly enough, an entire subclause 7.3 is devoted to collaboration. Collaboration is the key to open the door to disruption.

We are used to managing the resources of time, money and people, but how do we manage knowledge, which is the lifeblood of innovation? This is a short clause in ISO 9001, but it gets a lot more attention in clause 7.4 of ISO 50501.

Linking closely to this is the need to have an IT infrastructure that enables the management of knowledge. This got far too little attention in ISO 9001. Strategic intelligence feeds this knowledge base, and again an entire clause is devoted to this.

One of the definitions of the innovation process is the conversion of new knowledge into new products and services. Those new products and services will have intellectual property (IP) related to them, and this will need protection. IP clause 7.4.3 is in this section, and IP gets a lot attention.

Competence 7.5, Awareness 7.6, Communication 7.7

Many human resource functions have included "innovation" in their list of competences for performance assessment, but they are not really clear on what they are asking for. In reality, they are usually looking for creativity, which is only one of the competences in innovation. Clause 7.5 provides considerable detail on competences needed.

The awareness and communication clauses are similar to ISO 9001, but with much more supporting information. Although ISO 9001 does not now require a manual, most organizations are continuing to use one, and this is where you can build in your innovation practices as in the documentation clause 7.8—especially given that many of them will be new to you.

Clause 8—Operation

In Alice’s Adventures in Wonderland, when the white rabbit asked the king where to begin its journey, the king replied, "Begin at the beginning and go on till you come to the end; then stop."1

That is the way we tend to approach standards. I certainly encourage you to do that in your first read of the standard. When it comes to implementation, however, I suggest a different approach.

Take a moment to think about change management. Implementing innovation management is a major change. The model in Figure 3 is one I use often. It stresses the importance of initiating change by identifying a burning platform and by a core team getting an early win.


That early win is going to come here in clause 8 using your innovation process. This is the heart of your IMS. Yes—start drafting your strategy. Yes—start planning the culture change. But you will find out what innovation is really like right here in the process.

If you have created an ISO 9001:2015 quality manual, I suggest you create a new working draft "Quality and Innovation Management" manual and consider creating a temporary clause 8.9 in the draft manual. Just call it, "Innovation Process." ISO 50501 refers to innovation initiatives in clauses 8.1 and 8.2. For the moment, you are going to have just one initiative while you prototype your innovation process.

Settle on a product that is fading or a process that is constantly failing, but don’t be overambitious. This is familiar territory for a quality professional. You need a diverse cross-functional team of people familiar with the issue you are going to address.

ISO 50501 Clause 8.2—Managing innovation initiatives gives you a comprehensive checklist of what you should consider as you plan your initiative.

Clause 8.3 gives you the process elements, and you will see it is similar to the model I have used for many years (see Figure 4). The main difference is that I see the innovation process as a continual cycle, and not a linear process that starts and stops. Similar to the PDCA model, right?


Clause 8.3.2—Opportunity

The process starts in clause 8.3.2 by identifying opportunities. If you are choosing to work on a process innovation, you will probably start with a gemba walkabout to understand what is and isn’t happening in the process. If it is a product you are trying to innovate, you will talk to the customer and ask questions such as, "Where do you waste time?" "What are the biggest hassles?" or "Which requirements are unclear or hard to meet?"

You also should do some process or product benchmarking and find out what other people are doing in your area of interest. You should collect a large volume of data and information, which you analyze to arrive at a clear problem definition.

Clause 8.3.3—Concept solution

This is where you take the knowledge from clause 8.3.2 and use techniques such as creative problem solving (often called ideation) to find concept solutions. These are just ideas at this point. This is where divergent thinking creates radical new solutions. Traditional problem solving used in the world of quality finds solutions within the status quo, repairing a broken step in a process or clarifying requirements. Creative problem solving finds an entirely new product or process.

Albert Einstein famously said, "No problem can be solved with the same level of consciousness that created it."2 This is where you step out of the box. Find many alternatives, and collect and analyze data on whether a solution is easy to copy, has high risk, has high cost or will take a long time to implement.

Clause 8.3.4—Validate concepts

Now you develop the "proof of concept" and prototype—either virtually or in reality—to find the weaknesses of a limited number of preferred solutions. The innovators’ maxim is "Fail early and fail fast," and we do this before we have incurred significant cost. Analyze the time, cost and risk data and test whether the solution can be copied. You may choose to protect the IP you have created, and that was addressed back in clause 7.

Clause 8.3.5—Working solutions

"Ease of use" is the maxim here. Too often, developers try to add their own pet ideas instead of going back to the user needs collected in clause 8.3.2. This is where prototyping validates the new service or product and not just the concept.

We solidify business partner relationships and mitigate risks. If a new offering has been developed for a specific customer, the trials and tests with that customer will uncover areas of difficulty so they can be removed. Clauses 8.3.3 to 8.3.5 in ISO 50501 will have a lot of alignment with clause 8.3 in ISO 9001:2015. I suggest you hold off trying to mesh them immediately. Learn from this first innovation experience and understand the process. The ISO 50501 process has a bigger scope than clause 8.3 in ISO 9001:2015.


Clause 8.3.6—Deploy solutions

I prefer to call this "deliver solutions." This clause at present misses some of the important commercial aspects of delivering a solution. The value proposition is a vital tool. Downstream risks—such as the user budget cycle—need to be borne in mind. You also switch the conversation from features to benefits at this point.

Clause 9—Performance evaluation

Metrics matter and can be different in the world of innovation—especially in the early creative steps. In those early steps, the metrics may be binary and tend to be subjective. Clause 9 on innovation performance indicators gives good guidance on the types of indicators that can be used—first at the input or creative end of the innovation process, and then for throughput when you measure speed and level of engagement, and finally at output where you measure results.

This clause does, of course, include the internal audit (or assessment) of the IMS and the management review, both of which are quite similar to ISO 9001:2015.

Clause 10—Improvement

After a solution is delivered, there is always learning to be gained. The impact may not be that anticipated, and weaknesses and gaps should be dealt with rapidly. This is where the strength of system thinking in an ISO management system strikes home. The system forces you to take action.

My aim here has been to introduce you to the structure and thinking in ISO 50501 and show you the opportunity to move beyond quality management to innovation management. As professed in ASQ’s Innovation Division, "Innovation is quality for tomorrow."


  1. Lewis Carroll, Alice’s Adventures in Wonderland, Macmillan Publishers International Ltd., 1865.
  2. Peter Merrill, Innovation Never Stops, ASQ Quality Press, 2015.

Peter Merrill is president of Quest Management Inc., an innovation consultancy based in Burlington, Ontario. Merrill is the author of several ASQ Quality Press books, including Innovation Never Stops (2015), Do It Right the Second Time, second edition (2009), and Innovation Generation (2008). He is a member of ASQ, previous chair of the ASQ Innovation Division and current chair of the ASQ Innovation Think Tank. Merrill is also head of delegation for his country to ISO/TC 279 Innovation Management.

Loved it
--Rebecca Sergio, 03-24-2018

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