Embracing Change - Embedding innovation into your QMS via ISO 9001:2015

by Peter Merrill

Two years ago, I described in this column how you can use ISO 9001 as the basis for innovation management.1 Many people were surprised because there is a tendency to think that a quality management system (QMS) based on ISO 9001 is inflexible. That is far from true, and I have previously quoted the agile manifesto2as an excellent frame of mind to have when developing your QMS. 

The International Organization for Standardization (ISO), however, is aggressively pursuing innovation with the formation last year of Technical Committee (TC) 279 on innovation management, on which I serve. Our first meeting was held in December 2013 and three working groups (WG) have been formed: 

  • WG1 is developing the new innovation management standard, initially as a guidance standard before becoming a requirements document. 
  • WG2 is developing terms and definitions.
  • WG3 is developing innovation tools. 

The next meeting of TC279 will be in October in Buenos Aires. 

Last year, I introduced you to ISO 10018 on people involvement and showed how it can be a great asset in drawing knowledge from people—the fuel of your innovation process.3 I was convener of ISO 10018 and I am delighted to see so much of its thinking now embraced by the revised version of ISO 9001. In the meantime, the revised ISO 9001 provides some great opportunities for innovators, but you must look carefully for those opportunities.

ISO 9001 changes

ISO 9001:2015 is at the draft international standard (DIS) stage. The structure of the standard is set. That means the clauses and subclauses are set, but the text within the clauses will be revised in the light of the comments received from around the world.

At a high level, there are some great improvements. The archaic term "management responsibility" has finally gone and it’s replaced with "leadership" (section 5) and planning (section 6). This is the language of business. "Resources" is retitled "support" (section 7) and the term "production realization" has been replaced with "operations" (section 8), which again reflects the language of business. The improvement section is also split in two and becomes performance evaluation (section 9) and improvement (section 10). This follows a structure adopted by ISO for all management system standards. I applaud this move forward; it means whether your management system is for quality, environment, or health and safety, it will have the same structure. 

There also are some major shifts in thinking behind the standard and that provides the agility that is so important for innovation. Risk is a significant introduction. The old standard implied risk, the new standard states it emphatically. What greater risk for an organization than to have a mature or declining offering? Enter the innovator!

Documentation of mandatory procedures has been eliminated, and the standard has shifted to ensure that processes and hence the system is in control. Some people say this means no quality manual is required. If you can find a better tool against which to evaluate the effectiveness of your QMS, then you can do so.

Innovation in ISO 9001

To refresh your memory, Figure 1 shows the steps of the innovation process.

Getting into specific clauses of the new standard, the first requirements appear in Section 4—Context of the organization. Context is about the internal and external factors that affect the organization—and of course for the innovator, that means external change. External change is the driver for innovation. In Clause 4.2—Needs and expectations of interested parties, this is where the innovator will address future needs. This is how you maintain future direction. This leads into Clause 4.3—Scope, which should include future offerings as well as today’s offerings. Clause 4.4—Processes is where you include your innovation process.

The quality management principles are in Annex B of the standard and B3—Leadership tasks organizations to set direction and objectives. One of your objectives should be innovation and your direction should be looking to the future. In Section 5—Leadership, clause 5.1 addresses strategic direction and Clause 5.1.2—Customer focus requires enhancement of customer satisfaction, and we, of course, address that by meeting unmet customer needs. This is reinforced in Clause 5.2—Policy by including future needs of your customer. Clause 5.3—Responsibility does not mention the title management representative, but it still requires someone to report on QMS performance. Clause 5.3 is where you will include your innovation champion.

Section 6—Planning is where risk is introduced and organizations are asked to plan it into the context of the organization to prevent future undesired effects. What is more undesired than to have no offering in the marketplace? Again, enter the innovator. Organizations are asked to address risk, and clearly, innovation is one of the primary activities for addressing future risk. In setting objectives (clause 6.2), the development of future offerings is a key objective. Clause 6.3—Planning of change means that, to quote Charles Darwin, "The species which will survive is that which responds to change."4 An organization’s change process must include the ability to respond to external change.

Section 7—Support shows Clause 7.1.2—People and Clause 7.1.6—Knowledgeas high-value clauses for the innovator. Clause 7.1.2 draws in ISO 10018, which is explained more fully in Annex C of ISO 9001. Clause 7.1.6—Organizational knowledge (also see Annex A7) is the fuel of the innovation process and includes the phrase "access the necessary additional knowledge." This is a key element of your innovation process and especially addresses the creative steps. 

Clause 7.2—Competence reminds users to know their innovation competencies. You can do this by going to www.petermerrill.com/self-assessment to identify your competence inventory. Then you need to fill the competence gaps.

Section 8—Operations is quite similar in structure to its predecessor, section 7 of ISO 9001:2008, but there are improvements in flow. Clause 8.2—Determination of requirements is improved with customer communication coming first in clause 8.2.1. There will be customer needs that do not become agreed requirements in Clause 8.2.3—Review of requirements. You should understand that if you identify a need in clause 8.2 that you cannot meet due to your own lack of capability, that is an innovation trigger. In this clause, the standard also asks us to obtain customer views and perceptions—another trigger for innovation.

Clause 8.3—Design and development has improved a lot with much better flow. However, work is still needed on clause 8.3.1, which addresses the applicability of design. The flow is now Clause 8.3.2—PlanningClause 8.3.3—InputClause 8.3.4—Control and Clause 8.3.5—Output, which makes far more sense. 

Clause 8.4 used to be purchasing and is now about "external providers," and for the innovator, this is one of the highest risk areas. A new offering means a new supplier or subcontractor. Clause 8.4.2 addresses control of these providers, and there are important words that say "outsourced processes are within the scope of the QMS," so risk must be managed here.

Clause 8.5 is about delivery, and this is often where innovators stumble. This is where you include your piloting process and clause 8.5.1 addresses validation of processes for your new offering. Don’t overlook Clause 8.5.5—Post delivery, where you evaluate issues with the user that you may have missed.

Finally, section 8 of the old standard is split into Section 9—Performance Evaluation and Section 10—ImprovementClause 9.1—Monitoring and measurement must include measurement of innovation, and I have written about this previously in QP.5 Clause 9.1 includes customer satisfaction measurement, which is often done poorly by a lot of organizations. The standard asks you to find views and opinions, as stated in clause 8.2. Don’t ask questions like: "Are you satisfied?" Instead, find opportunities by asking: "Where do you waste time?" or "Where do you have difficulty?" 

Clause 9.1.3 tells you whether needs have been met and points to those future opportunities. Clause 9.2—Internal audit also will point you to internal process opportunities for innovation. Clause 9.3—Management review says to not just look at history, but look to the future and address changes. Clause 9.3.2 says to identify innovation opportunities.

Section 10—Improvement importantly points to the fact that improvement can be achieved through creativity and innovation.

I have sprinted the ISO 9001 marathon in this column, but my aim was to outline how you can embed innovation into your QMS as you transition to the revised standard. You can do this by creating an agile QMS, which is what the revised standard is calling for.


  1. Peter Merrill, "Time for Change," Quality Progress, July 2012, pp. 42-43.
  2. Wikipedia, "Agile software development," http://en.wikipedia.org/wiki/agile_software_development#agile_manifesto.
  3. Peter Merrill, "The People Principle," Quality Progress, September 2013, pp. 42-44. 
  4. Charles Darwin, On the Origin of Species, 1859.
  5. Peter Merrill, "In the Lead," Quality Progress, September 2008, pp. 26-32.