Quality managementQuality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management.
Quality management systemA quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling.
Verification and validationVerification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party.
ISO 9000The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.
Specification (technical standard)A specification often refers to a set of documented requirements to be satisfied by a material, design, product, or service. A specification is often a type of technical standard. There are different types of technical or engineering specifications (specs), and the term is used differently in different technical contexts. They often refer to particular documents, and/or particular information within them. The word specification is broadly defined as "to state explicitly or in detail" or "to be specific".
Reliability engineeringReliability engineering is a sub-discipline of systems engineering that emphasizes the ability of equipment to function without failure. Reliability describes the ability of a system or component to function under stated conditions for a specified period of time. Reliability is closely related to availability, which is typically described as the ability of a component or system to function at a specified moment or interval of time. The reliability function is theoretically defined as the probability of success at time t, which is denoted R(t).
Quality (business)In business, engineering, and manufacturing, quality – or high quality – has a pragmatic interpretation as the non-inferiority or superiority of something (goods or services); it is also defined as being suitable for the intended purpose (fitness for purpose) while satisfying customer expectations. Quality is a perceptual, conditional, and somewhat subjective attribute and may be understood differently by different people. Consumers may focus on the specification quality of a product/service, or how it compares to competitors in the marketplace.
Quality controlQuality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and identification of records Competence, such as knowledge, skills, experience, and qualifications Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships.
Statistical process controlStatistical process control (SPC) or statistical quality control (SQC) is the application of statistical methods to monitor and control the quality of a production process. This helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste scrap. SPC can be applied to any process where the "conforming product" (product meeting specifications) output can be measured. Key tools used in SPC include run charts, control charts, a focus on continuous improvement, and the design of experiments.
Agile software developmentIn software development, agile practices (sometimes written "Agile") include requirements discovery and solutions improvement through the collaborative effort of self-organizing and cross-functional teams with their customer(s)/end user(s), Popularized in the 2001 Manifesto for Agile Software Development, these values and principles were derived from and underpin a broad range of software development frameworks, including Scrum and Kanban.
Six SigmaSix Sigma (6σ) is a set of techniques and tools for process improvement. It was introduced by American engineer Bill Smith while working at Motorola in 1986. Six Sigma strategies seek to improve manufacturing quality by identifying and removing the causes of defects and minimizing variability in manufacturing and business processes. This is done by using empirical and statistical quality management methods and by hiring people who serve as Six Sigma experts.
Quality engineeringQuality engineering is the discipline of engineering concerned with the principles and practice of product and service quality assurance and control. In software development, it is the management, development, operation and maintenance of IT systems and enterprise architectures with a high quality standard. Quality engineering is the discipline of engineering that creates and implements strategies for quality assurance in product development and production as well as software development.
Medical deviceA medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases.
Scientific managementScientific management is a theory of management that analyzes and synthesizes workflows. Its main objective is improving economic efficiency, especially labor productivity. It was one of the earliest attempts to apply science to the engineering of processes to management. Scientific management is sometimes known as Taylorism after its pioneer, Frederick Winslow Taylor. Taylor began the theory's development in the United States during the 1880s and 1890s within manufacturing industries, especially steel.
Software qualityIn the context of software engineering, software quality refers to two related but distinct notions: Software's functional quality reflects how well it complies with or conforms to a given design, based on functional requirements or specifications. That attribute can also be described as the fitness for purpose of a piece of software or how it compares to competitors in the marketplace as a worthwhile product. It is the degree to which the correct software was produced.
Software testingSoftware testing is the act of examining the artifacts and the behavior of the software under test by validation and verification. Software testing can also provide an objective, independent view of the software to allow the business to appreciate and understand the risks of software implementation. Test techniques include, but are not necessarily limited to: analyzing the product requirements for completeness and correctness in various contexts like industry perspective, business perspective, feasibility and viability of implementation, usability, performance, security, infrastructure considerations, etc.
Total quality managementTotal quality management (TQM) consists of organization-wide efforts to "install and make permanent climate where employees continuously improve their ability to provide on demand products and services that customers will find of particular value." "Total" emphasizes that departments in addition to production (for example sales and marketing, accounting and finance, engineering and design) are obligated to improve their operations; "management" emphasizes that executives are obligated to actively manage quality through funding, training, staffing, and goal setting.
