04. Jul 2016

Innovation with Quality

Designing the future by using ISO 9001:2015

It is not in every company that quality management and innovation are a couple working synergistically. After all, cooperation is controlled by apparent conflicting targets. Innovation is to help new products to reach the customer and markets as soon as possible: New solutions, which often are radical, should be tried out and directly tested or used by the customer as soon as possible. Quality management, for its part, builds upon capable processes, legal certainty and the capability of durably meeting the customers’ requirements.

In some companies, creative workshops are shielded locally or organizationally. This is done in order to ensure that the fact that problems and open issues are shown too early does not lead to a loss of the courage for change. However, today’s business world is characterized by increasing dynamism and complexity. Product life cycles are becoming shorter, and technological changes and innovations coin our lives in all areas. At the same time, we are at the start of the next technological change due to rising interlinking and digitization in all areas of life. Only if a company is capable of simultaneously driving change and designing stable processes can this company act successfully in today’s business world.


Approaches of ISO 9001:2015

How does ISO 9001:2015 tackle the challenges placed by a global, dynamic and complex world - what are the pillars relating to the topics of innovation and innovation management? And how is the field of tension between stability and variability handled? The competent ISO Technical Committee started working at the revision leading up to ISO 9001:2015 by drawing up concepts for the future. Surveys made among users resulted in a specification for the new Standard that laid down that the revision should help to ensure that changes in an increasingly complex, demanding and dynamic environment, in which organizations are operating, are reflected. For this purpose, some elements with a special significance for innovations were added to the Standard while other elements saw a further development:


Considering the context of the organization

In the past, the primary focus of ISO 9001 in terms of the business environment was on managing the value added chain. Concrete requirements relating to customers and suppliers had always been a key concern of the Standard. At today’s market conditions, this is not sufficient to ensure changeability. Consequently the Standard now has new requirements asking the organization to identify internal and external topics that are relevant to the organization’s purpose and strategic direction and have an effect on the organization’s ability to achieve the intended results of the organization’s quality management system. Examples of these topics include technologies, social changes, legal changes, the organization’s own capability and performance as well as corporate culture.


Alignment to the strategy

Still another clear requirement is that for aligning the quality management system to the organization’s strategy. As early as at the determination of the context of the environment, it is required to take topics that are relevant in strategic terms into account. Moreover, the consistency of the system is demanded. This means that policy and the objectives and targets need to be compatible with the context of the organization and the organization’s strategic direction. The task of balancing these elements while conducting periodic reviews and triggering further developments is assigned to top management. However, the strategic direction also needs to be considered at an operational level: For example, the process approach also covers the necessity to systematically identify and control processes and their interactions as to make sure that the results striven for are congruent with the organization’s policy and strategic direction.


Identifying risks and opportunities

In a complex world full of changes, it will often be impossible to guarantee that all information necessary to estimate topics is available. Correspondingly there will be risks - this means uncertainties, which can have positive or negative effects. It is exactly at this point that ISO 9001:2015 starts out by requiring “risk-based thinking” to be anchored within the organization. This requirement for establishing risk-based thinking has enabled a partial reduction of the prescriptions and helped to substitute them for requirements focusing on performance. In concrete terms, this is reflected by the fact that ISO 9001:2015 is more flexible than ISO 9001:2008 with its requirements placed on processes, documented information and responsibilities within the organization. This additional asset for organizations that are innovative and open to change is more than welcome! Moreover, the way to grasp opportunities systematically is addressed just as well. In this respect, the Standard also reflects the link to possible fields of innovation. In Clause 0.3.3, ISO 9001:2015 runs as follows: “Opportunities can arise as a result of a situation favourable to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity.” 


Managing changes

Change management also is addressed in the Standard. In the past, the focus was on stability or, in concrete terms, the preservation of integrity within the quality management system. Now there are concrete requirements when it comes to systematically implementing a change - by way of planning considering responsibilities and resources and having a look at the consequences of changes.


Changing systems - even radically

It also is in the past that the term of “continual improvement” was used in different ways. Some interpreted the term by stating that the organization was continually working at improvements by using many different approaches - which meant that even big changes were covered. In practice, there mostly was the interpretation of a “continual improvement process” (CIP), i.e. a process in which approaches for improvement resulting from daily practice would systematically be implemented. Typically such a process will neither include innovation nor strategic change management. Now it is made clear that an organization needs to track all approaches necessary to ensure that products and services meet the requirements and that even future requirements and expectations can thus be fulfilled. In concrete terms, correction, corrective actions, continual improvement, breakthrough change, innovation and re-organization are mentioned in the Standard. 


Developing products and services

Innovation of products and services leads up to development activities. In the past, some organizations sweepingly excluded this topic from their field of application. In this respect, the Standard rather was prescriptive, and it was strenuous to harmonize it with development models that focused on creativeness or were dynamic. Now the requirements relating to design and development have been changed according to these circumstances while exclusions from the Standard no longer are allowed. In order to review usability of the new requirements, the organization will have to deal with them in detail. So this is a good time to systematically deal with the topic.


Quality management systems creating value for the organization

Context, strategy, stakeholders, opportunities and risks - this is the language of business. In this respect, a quality management system needs to support the organization and top management in ensuring that the customer requirements are met and customer satisfaction is increased. This is good news for all Quality Managers for whom the quality management system is a future oriented element of design. Thanks to the extended requirements in connection with management commitment, Quality Managers are strengthened when it comes to continuing to pursue their strategy.


Where can the term of innovation be found?

ISO 9001:2015 uses the term of “innovation” very sparingly. Innovation is stated as being a method or way of improvement. “Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization" (ISO 9001, Clause 0.1, Introduction).

If, however, we have a look at the concrete requirements, we will see that ISO 9001:2015 places concrete requirements in many areas when it comes to dealing with the innovation of the system, processes, products and services as well as changes of, e.g., business models. Equally typical phases of innovation management are addressed. Examples include the observation of the changes of customer expectations or technological changes (context), addressing of “future customer requirements”, planning of changes, product and service development, having a look at risks and opportunities or product/service tests (verification and validation in the language of the Standard).

It would be useful to deal with the two technical worlds more intensively in order to find a common language and help the right combination of the two worlds to support organizations on their way to success as well as possible. Quality and innovation do not contradict each other but are - in today’s business environment - topics that are highly overlapping and can only be implemented usefully if they are used together within the organization.

Author and Contact Person


Ms. Dr. Anni Koubek

Executive Vice President Innovation, Business Development Certification Quality

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