ISO 9001:2015 Quality management system is based on processes, critical success factors for them, measurement and analysis of processes, and continuous improvement. This section describes how processes are used to in a quality management system. (See Figure 3 and SFS 2017, 28.) The KPIs and continuous improvement are described in more detail in their own chapters. (See Chapter 3.4 and Chapter 3.5.)
Figure 3. ISO 9001:2015 Quality Management System Process Model (SFS 2017, 28)
The ISO 9001 quality management system is based on processes which has been built in accordance with the functions and objectives and continuously developing these processes.
There are several requirements for building the processes. Define the processes required for the quality management system and apply them throughout the organization. It will also be necessary to determine the order and interaction of the above processes, as well as the criteria and methods to ensure the operation and control of these processes. Then, the availability of resources and information needed to support the operation and monitoring of these processes
a) Determine the processes
should be ensured and monitored, measured and analyzed, and decisions made based on facts (measurement results). Finally, steps must be taken to implement the planned measures and to continuously improve the processes. (SFS-EN ISO 9001 2015, 6)
The process consists of the activity, the resource, the output, and the performance that determines their effectiveness throughout the process (Laamanen 2005, 20). Laamanen (2005, 19-22) defines a business process as a series of logically related recurring activities within an organization, supplemented by the resources needed for implementation to deliver the desired results. Process thinking starts with the customer's needs and then must be thought about what kind of supply the customer's needs can be met. To do this, the processes (actions and resources) were designed and were considered that what kind of inputs (information, materials, vendors) are used to implement the processes. Adding value to the organization's supply chain from supplier to internal or external customer is done through processes, by adding resources to the processes that are needed to achieve the desired end-result (Bergman & Klefsjö 2010, 457).
Business processes can be separated into core processes that create value for customers and other stakeholders, and support processes that create the conditions for core processes. The role of support processes is to create value within the organization and act as a feeder to the core processes. (Laamanen 2005, 52-57) Laamanen (2005, 297) identifies the risks of process management as the inability to identify and distinguish between core and support processes, too many processes (over 20) or responsibilities are not clear. In addition, processes may not be fully utilized because they are not recognized, have no goals, are not measured, or are not properly rewarded.
A series of process steps goes through the functions of the entire organization. It is based on the needs of the customer and the desired result is an operation that the customer is satisfied with. The process continuously takes customer feedback into account as a self-improving function. (Laamanen 2005, 22; Grönroos 2009, 57) The horizontal flow of processes from supplier to customers throughout the organization, including suppliers and subcontractors, is described in the process map below (Figure 4) (Gillett et al. 2015, 187-190).
Figure 4. The Process Map of Organization (Gillett et al. 2015, 187-190)
Business processes can be separated into core processes that create value for customers and other stakeholders, and support processes that create the conditions for core processes. The role of support processes is to create value within the organization and act as a feeder to the core processes. (Laamanen 2005, 52-57) Laamanen (2005, 297) identifies the risks of process management as the inability to identify and distinguish between core and support processes, too many processes (over 20) or responsibilities are not clear. In addition, processes may not be fully utilized because they are not recognized, have no goals, are not measured, or are not properly rewarded.
O’Brien (2014, 12-13) lists Common types of supplier relationship: 1. Arm’s length supplier is the supplier of individual named supplements 2. Subcontractor is the company’s own resources supplier 3. Preferred supplier is the contract supplier 4. Outsourced provider provides a partial service to the company, continuously replacing the same function within the company 5. Critical supplier is a supplier whose activities have a critical impact on the company's operations 6. Strategic supplier is a strategically important partner for the company's development 7. Partner is a contractual partner 8. Group company is a company owned or belonging to the same group. [A company should evaluate the effects of different
types of suppliers on company’s own processes. In assessing risks and opportunities, the specificities, importance and criticality of suppliers should also be taken into consideration.]
Krajevski et al. (2019, 586-587) depicts integrated supply chains with Figure 5. It illustrates the integration between the company and the supplier and the customers. The goal is to achieve benefits for the entire supply chain through collaboration. As Krajevski et al. (2019, 586-587) states, this is a long-term process, but its benefits are significant in any case.
Figure 5. Integrated supply chains (Krajevski et al. 2019, 587)
The process interaction with other processes can be described by the "waterfall model"
(Figure 6), where the output of the previous process is the next input. Support processes for core processes are such, as management, personnel, and administration (Pesonen 2007, 134).
Figure 6. Process Interaction (Pesonen 2007, 134; Kruchten 2003, 54)
Successful use of the interactive development process waterfall model (Figure 6) requires a step-by-step response (Kruchten 2003, 54). The reasons for failure can be, according to Kruchten (2003, 55): 1. Incorrect initial assumptions. 2. Attempts to solve the problem in the wrong contex.t 3. Incorporation of some irrelevant human factors. 4. Modified approach to wrong. 5. Insufficient experience in the area to be resolved.
The iterative process model repeats the waterfall model all over again (Kruchten 2003, 60-61). It allows you to make changes during the process. The advantages over the traditional waterfall model are faster response, more manageable changes, better response and process improvement, in-process learning and improved end-product quality. (Kruchten 2003, 76) If, in the process of applying the waterfall model, measurement, analysis and corrective action are not carried out at a sufficiently short frequency during the process, any errors in any of the sub-processes will accumulate as a result of the failure. Measurement periods should preferably be 2-6 weeks rather than 6-12 months. The periods must be short enough for an effective response. (Larman et al. 2001, 4-5) A process-like operating model can also be described in the process map of Figure 7, where interactive processes meet customer expectations (Pesonen 2007, 137).
Marketing Process
Sales Process
Product Development
Process
The service implementation
process
Customer Service Process
Figure 7. The Process Map of Sales Company (Pesonen 2007, 137)
Corporate management defines a common purpose and direction for the organization and creates conditions and resources. Process planning ensures that they function as interrelated processes within a single system. Processes are used to implement the supply. Measuring, tracking, and controlling anomalies in processes and their sub-functions, as well as analyzing information, ensures continuous improvement of the processes. (Figure 8) (Moisio &
Tuominen 2008, 6)
Figure 8. Quality Management System ISO 9001 (Moisio & Tuominen 2008, 6)
•Strategic Planning