Lean methods and ISO 9001:2015 - does that go together?

ISO 9001 is the most important quality management standard, which is reflected not least in the certification figures [1]. However, this quality management is sometimes said to require an excessive amount of documentation and to create only additional effort and no added value. Studies show what many managers and quality management officers already know instinctively: The motivation for certification is crucial. Awarding the certificate for the sole purpose of external presentation fails to achieve the hoped-for improvements to the greatest possible extent. Real added value only comes from the motivation to improve internal processes [2].

Process-oriented approach strengthened
The ultimate goal of a quality management system (QMS) according to ISO is "[...] to meet customer requirements and strive to exceed customer expectations [...]" [3]. ISO 9001:2015, which has been mandatory since the end of the transition period, has further strengthened the process-oriented approach by explicitly requiring process metrics. In addition, requirements for expanding the analysis of the environment, for dealing with risks and opportunities, and for knowledge management have also been added. The removal of the explicit requirement for a QMB reinforces the responsibility of management [4]. This change goes hand in hand with findings that emphasize the importance of management support for a successful QMS [2].

At the same time, various lean management methods have long been established and are applied in numerous companies, even outside the general cargo industry [5]. The positive influence on various aspects of company performance is generally accepted [6, 7]. The overriding goal of the philosophy developed from the Toyota Production System is the consistent identification and avoidance of waste [8].

In companies, however, both topics are still partly not integrated [9], although the connection is often described [cf. 10, 11]. Even if the goals are slightly different, they are complementary systems whose lack of integration represents a waste. To show the connection of a QMS according to ISO 9001 and Lean Management, first the principles are contrasted. For a practical implementation, selected requirements of the standard are then brought together with established methods of lean management.

Another form of customer orientation
The principle of customer orientation of ISO 9001 is also found, as shown in the figure, in the design principles of avoiding waste, the pull principle and the zero defect principle. In accordance with the goals of lean management, however, these principles are directed more towards the internal view and thus the more efficient design of processes. Since waste is defined in lean thinking as everything the customer is not willing to pay for, it reflects a different form of customer orientation. According to Pull, only customer needs are responded to, and the zero defect principle states that no defects should be passed on to customers (even internal ones). The QM principles of leadership and involvement of people are also reflected in lean management, as employees are of essential importance in this. The process-oriented approach of quality management is found in the flow principle, since here information flows quickly along a process and the organization is aligned with the sem. At the same time, the process-oriented approach and standardization have much in common and thus form the basis for the improvement demanded in both concepts [12, 13].

But how can lean management and ISO 9001 also be brought together operationally? One approach can be the use of lean management methods for the implementation of the standard requirements. For example, it has already been shown that the Shopfloor Management (SFM) method can provide operational support for the increased management responsibility of standard revision [14]. In addition, there are other established methods that can support the implementation of standard requirements. Some of these will be discussed below by way of example.

One of the changes in standards is the demand for process indicators. These are already represented in Lean Management as a control instrument. Methods that can be used here are process standardization, SFM and Andon. Closely related to this is the Hoshin Kanri method, which specifies an overriding objective for successful process control and thus ensures uniform alignment within the company. Through the Hoshin Kanri method, the corporate strategy is developed, broken down to the units and implemented through measures [16]. This enables the standard requirements of chapter 6.2 "Quality objectives and planning to achieve them" to be fulfilled. Since Hoshin Kanri covers the entire PDCA cycle, the achievement of the objectives is also checked and thus parts of Chapter 9 "Assessment of performance" are already fulfilled [17, 18]. In order to achieve a certifiable level here, the corresponding requirements for documented information must be observed. However, the new introduction of this term in the standard vision means that organizations now have more freedom to define it.

The new requirements for knowledge management can also be implemented very well with lean management methods, since one of its main concerns is to enable employees to improve the system. The methods of work structuring, competence profile and qualification matrix, which are assigned to the design principles of self-development and coaching, are suitable here in the catalogue of methods. In this context, the connection to digitalization and the associated changes should also be taken into account [19].

The method referred to in lean management as customer orientation is intended to take into account the requirements of customers (both internal and external) in the company processes [16]. In order to meet the new requirements of the standard for recording interested parties, it is conceivable to embed further stakeholders in this method. In this context, lean methods can also be supplemented by QM.

QMS as an impulse for Lean Management
The examples presented show that established lean management methods can meet standard requirements and thus increase the integration of lean and ISO 9001 and reduce duplication of effort. However, it is also evident that a Lean method does not exist for every ISO 9001 task. A QMS, for example, can certainly help to consolidate lean methods in the company and to record them with suitable documentation. At the same time, despite efforts to generalize lean methods to a so-called lean enterprise, they often still refer to the areas directly involved in value creation. The standard has a broader focus in this respect and already includes service provision and indirect areas.

Thus, a combination of both approaches can support exactly what constitutes added value - by using established lean methods, the focus is placed on improving internal processes, and the intensive examination of internal processes can at the same time ensure profitability and the fulfillment of customer requirements. The methods should always fit into the overall context of the organization and should not be implemented for the sole purpose of obtaining certification.