The following definition of quality management is taken from the quality standard DIN EN ISO 9000:2005. This standard provides internationally recognized and clear definitions of the terms. Here, a quality management system is defined as “that part of an organization’s management system which, in relation to quality objectives, is directed towards achieving results to satisfy, as far as is reasonable, the needs, expectations and requirements of interested parties”. Thus, a quality management system is essentially responsible for ensuring that customer requirements are met. In doing so, many factors such as employees, processes, machines or information must be taken into account, coordinated and managed. The task of the quality management system is to integrate these factors into an integrated system in order to successfully design and manage them within the company. In accordance with the meaning of the word prevention, preventive quality management can be defined as a “management system for meeting customer requirements with the intention of anticipating non-fulfillment of customer requirements and detecting and eliminating errors or deviations as early as possible”. According to DIN EN ISO 9000:2005, a quality management system has three core elements: quality planning, quality assurance and quality control, which are explained below.
Quality planning is defined as “a part of quality management that is focused on establishing the quality objectives and the necessary execution processes and associated resources to meet the quality objectives”. The instruments of quality planning are known as quality methods. The best known of these are the two methods Advanced Product Quality Planning and Failure Mode and Effects Analysis (FMEA). Quality planning includes planning for the product (identifying and prioritizing quality attributes, defining quality objectives, quality requirements, and constraints), planning for management and execution activities (defining quality objectives for manufacturing processes, test and measurement equipment, and process enablement), and developing QM plans and providing for quality improvement. Quality planning is therefore the setting of quality objectives, consistent risk assessment and the enabling of products and processes.
According to DIN EN ISO 8402, 1995-08, clause 3.5, quality assurance is any planned and systematic activity that is implemented within the QM system and that is designed to create confidence that a unit will meet the quality requirement. Quality assurance is thus the sum of all measures to ensure constant product quality. A distinction is made between internal monitoring and external monitoring. Known methods in the context of quality assurance are classical testing with the aid of testing and measuring equipment, statistical process control (SPC) and the analysis, prioritization and correction of defects. Quality assurance is thus the sum of all measures to ensure constant product and process quality from the customer’s point of view.
Quality control is the part of quality management that is focused on the fulfillment of quality requirements. Quality control includes work techniques and activities both for monitoring a process and for eliminating the causes of unsatisfactory results. Quality control measures and quality assurance measures are interrelated. Quality control thus comprises all working techniques and activities for the analysis of a process and for the elimination of causes of defects. Based on the definition of quality used in this thesis, the overriding goal of preventive quality management is understood to be sustainable quality improvement in the sense of higher product and process quality.
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