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".
TraceabilityTraceability is the capability to trace something. In some cases, it is interpreted as the ability to verify the history, location, or application of an item by means of documented recorded identification. Other common definitions include the capability (and implementation) of keeping track of a given set or type of information to a given degree, or the ability to chronologically interrelate uniquely identifiable entities in a way that is verifiable. Traceability is applicable to measurement, supply chain, software development, healthcare and security.
Quality assuranceQuality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design.
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.
Accuracy and precisionAccuracy and precision are two measures of observational error. Accuracy is how close a given set of measurements (observations or readings) are to their true value, while precision is how close the measurements are to each other. In other words, precision is a description of random errors, a measure of statistical variability. Accuracy has two definitions: More commonly, it is a description of only systematic errors, a measure of statistical bias of a given measure of central tendency; low accuracy causes a difference between a result and a true value; ISO calls this trueness.
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.
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.
StandardizationStandardization or standardisation is the process of implementing and developing technical standards based on the consensus of different parties that include firms, users, interest groups, standards organizations and governments. Standardization can help maximize compatibility, interoperability, safety, repeatability, or quality. It can also facilitate a normalization of formerly custom processes.
Acceptance testingIn engineering and its various subdisciplines, acceptance testing is a test conducted to determine if the requirements of a specification or contract are met. It may involve chemical tests, physical tests, or performance tests. In systems engineering, it may involve black-box testing performed on a system (for example: a piece of software, lots of manufactured mechanical parts, or batches of chemical products) prior to its delivery.
